| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00884838092914 | 4598-006-53451 | 4598-006-53451 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | DA200P40 |
| 2 | 00884838092907 | 9896-055-88704 | 9896-055-88704 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | DA200ULTRA |
| 3 | 00884838092884 | 4598-006-49221 | 4598-006-49221 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CTR2280CESV |
| 4 | 00884838092877 | 4598-006-49211 | 4598-006-49211 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CTR2280CESV |
| 5 | 00884838092785 | 4598-003-95581 | 4598-003-95581 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CTR1720 |
| 6 | 00884838092723 | 9896-055-95221 | 9896-055-95221 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CTR1720 |
| 7 | 00884838092655 | 9890-000-87081 | 9890-000-87081 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CTR1725 |
| 8 | 00884838092648 | 9890-000-87071 | 9890-000-87071 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CTR1725 |
| 9 | 00884838092631 | 9890-000-87061 | 9890-000-87061 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CTR1725 |
| 10 | 00884838092624 | 9890-000-87051 | 9890-000-87051 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CTR1725 |
| 11 | 00884838092617 | 9890-000-87041 | 9890-000-87041 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CTR1725 |
| 12 | 00884838092600 | 9890-000-87031 | 9890-000-87031 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CTR1725 |
| 13 | 00884838092204 | 9896-055-92424 | 9896-055-92424 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CTR2150CEPN |
| 14 | 00884838092174 | 9896-055-92403 | 9896-055-92403 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CTR2150CEPN |
| 15 | 00884838088542 | 9890-000-70298 | 9890-000-70298 | X-ray control and HV generator | IZO | Generator, high-voltage, x-ray, diagnostic | 1 | Velara R/F 2T |
| 16 | 00884838076426 | 9890-000-86471 | 9890-000-86471 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | SRO 2550 ROT 380 |
| 17 | 00884838076174 | 9890-000-85092 | 9890-000-85092 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | MRC 200 0310 ROT-GS 1004 |
| 18 | 00884838076143 | 9890-000-70297 | 9890-000-70297 | X-ray control and HV generator | IZO | Generator, high-voltage, x-ray, diagnostic | 1 | Velara R/F 2T |
| 19 | 00884838092860 | 4598-005-94291 | 4598-005-94291 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CTR1735 |
| 20 | 00884838092730 | 9896-055-95231 | 9896-055-95231 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CTR1735 |
| 21 | 00884838088559 | 9890-000-70308 | 9890-000-70308 | X-ray control and HV generator | IZO | Generator, high-voltage, x-ray, diagnostic | 1 | Velara GCF 2T |
| 22 | 00884838076396 | 9890-000-86352 | 9890-000-86352 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | PHILIPS MRC 880 |
| 23 | 00884838076334 | 9890-000-86062 | 9890-000-86062 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | MRC 200 0508 ROT-GS 1005 |
| 24 | 00884838076310 | 9890-000-85892 | 9890-000-85892 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | PHILIPS MRC 600 |
| 25 | 00884838076150 | 9890-000-70307 | 9890-000-70307 | X-ray control and HV generator | IZO | Generator, high-voltage, x-ray, diagnostic | 1 | Velara GCF 2T |
| 26 | 00884838076075 | 9890-000-63272 | 9890-000-63272 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | MRM 0410 ROT-GS 2502 |
| 27 | 00884838076013 | 9890-000-30031 | 9890-000-30031 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | MRC 200 0508 ROT-GS 1001 PREOWNED |
| 28 | 00884838076006 | 9890-000-30021 | 9890-000-30021 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | MRC 200 0508 ROT 1003 PREOWNED |
| 29 | 00884838075924 | 9806-058-00104 | 9806-058-00104 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CT XS Tube |
| 30 | 00884838074279 | 9890-010-87752 | 706050 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Wireless Portable Detector |
| 31 | 00884838092945 | 9890-000-86502 | 9890-000-86502 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | MRC 200 0407 ROT-GS 1004 |
| 32 | 00884838092891 | 9896-055-96401 | 9896-055-96401 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | REEVO240G |
| 33 | 00884838089969 | 9890-000-86092 | 9890-000-86092 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | SRO 2550 ROT 360 |
| 34 | 00884838089945 | 9890-000-86102 | 9890-000-86102 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | SRO 33100 ROT 360 |
| 35 | 00884838076457 | 9890-000-86501 | 9890-000-86501 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | MRC 200 0407 ROT-GS 1004 |
| 36 | 00884838076440 | 9890-000-86482 | 9890-000-86482 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | SRO 33100 ROT 380 |
| 37 | 00884838076433 | 9890-000-86481 | 9890-000-86481 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | SRO 33100 ROT 380 |
| 38 | 00884838076358 | 9890-000-86101 | 9890-000-86101 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | SRO 33100 ROT 360 |
| 39 | 00884838076341 | 9890-000-86091 | 9890-000-86091 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | SRO 2550 ROT 360 |
| 40 | 00884838076280 | 9890-000-85831 | 9890-000-85831 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | SRO 2550 ROT 350 |
| 41 | 00884838076181 | 9890-000-85103 | 9890-000-85103 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | MRC 200 0407 ROT-GS 1004 |
| 42 | 00884838076167 | 9890-000-85002 | 9890-000-85002 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | SRM 0612 ROT 504 |
| 43 | 00884838074286 | 9890-010-88161 | 712031 | Radiologic table | KXJ | Table, radiologic | 2 | Portable DR Panel Protector |
| 44 | 00884838004047 | 9890-010-83731 | 732050 | System Image Processing, Radiological | LLZ | System, image processing, radiological | 2 | PCR ELEVA |
| 45 | 00884838103221 | 706110 | JAA,KPR | System, X-Ray, Fluoroscopic, Image-Intensified,System, X-Ray, Stationary | 2 | ProxiDiagnost N90 | ||
| 46 | 00884838102613 | 9890-000-87251 | 9890-000-87251 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | DA200P40+LMB |
| 47 | 00884838093522 | 9890-000-30101 | 9890-000-30101 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | Philips MRC 880 CPO |
| 48 | 00884838092983 | 9890-000-03362 | 9890-000-03362 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | SRM 0511 ROT 501 |
| 49 | 00884838092976 | 9890-000-86742 | 9890-000-86742 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | MRC 200+ 0407 ROT-GS 1004 |
| 50 | 00884838092778 | 4598-003-42971 | 4598-003-42971 | diagnostic x-ray tube housing assembly | ITY | Assembly, tube housing, x-ray, diagnostic | 1 | CTR2150CEAN |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08806167789466 | USO-U0N5B0K/WR | 5D Viewer | SAMSUNG MEDISON CO., LTD. | ||
| 2 | 08806167761172 | USO-U0N5B0B/WR | 5D VIEWER | SAMSUNG MEDISON CO., LTD. | ||
| 3 | 08806094744934 | F4335-AW | Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System t Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 4 | 08806094458220 | S4343-AWM | Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System t Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 5 | 08806094458213 | S4335-AWM | Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System t Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 6 | 08806090171147 | GR40CWD | The GR40CW and GR40CWD Digital X-ray Imaging System is intended for use in gener The GR40CW and GR40CWD Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 7 | 08806088773797 | GR40CW | The GR40CW Digital X-ray Imaging System is intended for use in general projectio The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 8 | 08806088670560 | GC70 | The GC70 Digital X-ray Imaging System is intended for use in generating radiogra The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 9 | 08806088670560 | GC70 | The GC70 Digital X-ray Imaging System is intended for use in generating radiogra The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 10 | 08806088582412 | GM85 | The GM85 Digital X-ray imaging System is intended for use in generating radiogra The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 11 | 08806088566313 | GU60A | The GU60A Digital X-ray Imaging Systems are intended for use in generating radio The GU60A Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 12 | 08806088566313 | GU60A | The GU60A Digital X-ray Imaging Systems are intended for use in generating radio The GU60A Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 13 | 08806088565231 | GC85A | The GC85A Digital X-ray Imaging System is intended for use in generating radiogr The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 14 | 08806088565231 | GC85A | The GC85A Digital X-ray Imaging System is intended for use in generating radiogr The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 15 | 08806088538440 | GR40CW | The GR40CW Digital X-ray Imaging System is intended for use in general projectio The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 16 | 08806088520971 | GU60A-65 | The GU60A-65 Digital X-ray Imaging Systems are intended for use in generating ra The GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 17 | 08806088520971 | GU60A-65 | The GU60A-65 Digital X-ray Imaging Systems are intended for use in generating ra The GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 18 | 08806088512266 | S4343-W | Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System t Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 19 | 08806088512211 | S3025-W | Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System t Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 20 | 08806088511153 | GM60A-32S | The GM60A-32S Digital Mobile X-ray Imaging System is intended for use in generat The GM60A-32S Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 21 | 08806088351889 | GF50A | The GF50A Digital X-ray Imaging System is intended for use in generating radiogr The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 22 | 08806088351889 | GF50A | The GF50A Digital X-ray Imaging System is intended for use in generating radiogr The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 23 | 08806088351872 | GF50 | The GF50 Digital X-ray Imaging System is intended for use in generating radiogra The GF50 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 24 | 08806088351872 | GF50 | The GF50 Digital X-ray Imaging System is intended for use in generating radiogra The GF50 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 25 | 08806088088266 | GM60A-40S | The GM60A-40S Digital Mobile X-ray Imaging System is intended for use in generat The GM60A-40S Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 26 | 08806086571210 | S4335-W | Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System t Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 27 | 08806086403467 | GC80 | The GC80 Series Digital X-ray imaging System is intended for use in generating r The GC80 Series Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 28 | 08806086403467 | GC80 | The GC80 Series Digital X-ray imaging System is intended for use in generating r The GC80 Series Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 29 | 08801643990107 | S4343-AW | Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System t Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 30 | 08801643990091 | S4335-AW | Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System t Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 31 | 08801643676568 | GR40CWC | The GR40CW and GR40CWC Digital X-ray Imaging System is intended for use in gener The GR40CW and GR40CWC Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 32 | 08801643431419 | S4335-WV | Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System t Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 33 | 08800086200064 | V-B-pAb-02 | Veuron-Brain-pAb2 | HEURON CO.,LTD. | ||
| 34 | 08800086200026 | V-B-pAb-01 | Veuron-Brain-pAb | HEURON CO.,LTD. | ||
| 35 | 08800086200019 | V-B-mN1-01 | Veuron-Brain-mN1 | HEURON CO.,LTD. | ||
| 36 | 08800061700015 | Mars1417V-TSI | Mars1417V-TSI Wireless Flat Panel Detector with only one package | Wireless Digital Flat Panel Detector | IRAY KOREA LIMITED | |
| 37 | 08800046800006 | 1.1.0 | ClariCT.AI | CLARIPI INC. | ||
| 38 | 08800025300084 | 1.1 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
| 39 | 08800025300077 | 1.1 | AVIEW | CORELINE SOFT CO.,LTD. | ||
| 40 | 08800025300039 | 1.0 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
| 41 | 08800025300022 | 1.1 | AVIEW Modeler | CORELINE SOFT CO.,LTD. | ||
| 42 | 08800025300015 | 1.0 | AVIEW | CORELINE SOFT CO.,LTD. | ||
| 43 | 08800023100006 | 1.0 | OnDemand3DTM | CYBERMED INC. | ||
| 44 | 08800022900089 | 1.0 | 1.0 | VARO Plan Software is a stand-alone Windows-based software application to suppor VARO Plan Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners for pre-operative planning and simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry. | VARO Plan | 3D INDUSTRIAL IMAGING CO.,LTD |
| 45 | 08800022900072 | 1.0 | DentiqAir is a software application for the visualization and segmentation of im DentiqAir is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. The software is intended to create design outputs to fabricate intraoral mandibular advancement devices used for the reduction of snoring. The dental professionals' planning data may be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems. Output of DentiqAir has not been 510(k) cleared yet. The export of the device design file should only be sent to manufacturer who hold a 510(k) for intraoral mandibular advancement devices using DentiqAir software. The manufacture of the device should occur as per the design specifications provided within the 510(k) clearance. | DentiqAir | 3D INDUSTRIAL IMAGING CO.,LTD | |
| 46 | 08800022900041 | 1.0 | DentiqGuide is a software device used to pre-operatively plan the placement of a DentiqGuide is a software device used to pre-operatively plan the placement of a dental implant and to visualize a patient’s CT image optionally aligned to an optical 3D surface data. Virtual crowns can be used to guide the planning under the final prosthetic aspect. The surgical guide data can be designed then exported to an external system for manufacturing. Key Lock. | DentiqGuide | 3D INDUSTRIAL IMAGING CO.,LTD | |
| 47 | 08800022900003 | 1.0 | 1.0 | Dentiq3D is a 3D visualization software for the analysis of various dental CT da Dentiq3D is a 3D visualization software for the analysis of various dental CT data. Dentiq3D provides intuitive and real-time 3D volume processing functions. | Dentiq3D | 3D INDUSTRIAL IMAGING CO.,LTD |
| 48 | 08800019700357 | 3.3 | EzDent-i is dental imaging software that is intended to provide diagnostic tools EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment. | EzDent-i | EWOO SOFT CO., LTD | |
| 49 | 08800019700340 | 5.4 | Ez3D-i is dental imaging software that is intended to provide diagnostic tools f Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions. | Ez3D-i | EWOO SOFT CO., LTD | |
| 50 | 08800019700319 | 1.3 | EzOrtho is a software indicated for use by dentists who provide orthodontic trea EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. | EzOrtho | EWOO SOFT CO., LTD |