| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00857377006339 | DGH 55B Calbox | The pachymeter calbox is an accessory that connects to a pachymeter and creates The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Pachmate 2 Calbox | |
| 2 | 00857377006308 | SM Calbox | The pachymeter calbox is an accessory that connects to a pachymeter and creates The pachymeter calbox is an accessory that connects to a pachymeter and creates a single precise, predetermined electronic pulse. The pachymeter measures the pulse, and the operator verifies that the measurement value is within an acceptable range. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Single Measurement Calbox | |
| 3 | 00857377006247 | DET 2006 | The DET2006 is a small, removable probe containing an ultrasonic transducer. Thi The DET2006 is a small, removable probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices. | ITX | Transducer, Ultrasonic, Diagnostic | 2 | DET 2006 Detachable Pachymeter Probe | |
| 4 | 00857377006230 | DGH 6006 | The DGH6006 is a corded probe containing an ultrasonic transducer. This probe is The DGH6006 is a corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic A-Scan devices. | ITX | Transducer, Ultrasonic, Diagnostic | 2 | DGH 6006 Corded A-Scan Probe | |
| 5 | 00857377006124 | DGH1920 | The DGH1920 is a single-element mechanical sector B-scan probe. This probe conne The DGH1920 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software. | IYO,ITX | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | 20 MHz B-Scan Probe | |
| 6 | 00857377006018 | DGH 555B | The DGH 555B is a Desktop Ultrasonic Pachymeter. It is a portable, battery-power The DGH 555B is a Desktop Ultrasonic Pachymeter. It is a portable, battery-powered electronic medical device that uses ultrasonic pulse technology to measure the thickness of the human cornea. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Pachette 4 | |
| 7 | 00857377006209 | DGH 1006 | The DGH1006 is a straight corded probe containing an ultrasonic transducer. This The DGH1006 is a straight corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices. | ITX | Transducer, Ultrasonic, Diagnostic | 2 | DGH 1006 Corded Pachymeter Probe | |
| 8 | 00857377006353 | DGH 555B Calbox | The pachymeter calbox is an accessory that connects to a pachymeter and creates The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Pachette 4 Calbox | |
| 9 | 00857377006322 | DGH 55 Calbox | The pachymeter calbox is an accessory that connects to a pachymeter and creates The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Pachmate Calbox | |
| 10 | 00857377006148 | DGH1500 | The DGH1500 is a single-element mechanical sector UBM probe. This probe connects The DGH1500 is a single-element mechanical sector UBM probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software. | ITX,IYO | Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | UBM Probe | |
| 11 | 00857377006223 | DGH 3006 | The DGH3006 is a corded probe containing an ultrasonic transducer. This probe is The DGH3006 is a corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic A-Scan devices. | ITX | Transducer, Ultrasonic, Diagnostic | 2 | DGH 3006 Corded A-Scan Probe | |
| 12 | 00857377006216 | DGH 2006 | The DGH2006 is an angled corded probe containing an ultrasonic transducer. This The DGH2006 is an angled corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices. | ITX | Transducer, Ultrasonic, Diagnostic | 2 | DGH 2006 Corded Pachymeter Probe | |
| 13 | 00857377006117 | Scanmate Flex | The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The system consists of three main components: an interface module with integrated probe holder, one or more ultrasonic probes, and the Scanmate software application. | ITX,IYO | Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Scanmate Flex USB Interface | |
| 14 | 00857377006100 | DGH 8000 | The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that co The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that connects to the user's PC via USB connection. The DGH 8000 uses ultrasonic pulse technology to create 2-dimensional, cross-section images of the human eye. | ITX,IYO | Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Scanmate B | |
| 15 | 00857377006346 | DGH 555 Calbox | The pachymeter calbox is an accessory that connects to a pachymeter and creates The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Pachette 3 Calbox | |
| 16 | 00857377006131 | DGH1912 | The DGH1912 is a single-element mechanical sector B-scan probe. This probe conne The DGH1912 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software. | IYO,ITX | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | 12.5 MHz B-Scan Probe | |
| 17 | 00857377006162 | DGH1500-50 | The DGH1500-50 is a 50 MHz ultrasonic element that is for use with the DGH1500 UBM Probe. | ITX,IYO | Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | UBM 50 MHz Transducer | |
| 18 | 00857377006155 | DGH1500-35 | The DGH1500-35 is a 35 MHz ultrasonic element that is for use with the DGH1500 UBM Probe. | ITX | Transducer, Ultrasonic, Diagnostic | 2 | UBM 35 MHz Transducer | |
| 19 | 00857377006315 | MM Calbox | The pachymeter calbox is an accessory that connects to a pachymeter and creates The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Multiple Measurement Calbox | |
| 20 | 00857377006094 | DGH 6000 | The DGH 6000 is a Portable Ultrasonic A-Scan. It is an electronic device that co The DGH 6000 is a Portable Ultrasonic A-Scan. It is an electronic device that connects to the user's PC via USB connection. It is a portable device that uses ultrasonic pulse technology to obtain axial length measurements of the human eye | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Scanmate A |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00191506017224 | H749009881CD0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
| 2 | 00191506017187 | H749009765R0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
| 3 | 00191506015206 | H749009881IZ0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
| 4 | 00191506015190 | H749009881IR0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
| 5 | 00191506015183 | H749009881I0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
| 6 | 00191506015176 | H749009881CZ0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
| 7 | 00191506015169 | H749009881CR0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
| 8 | 00191506015152 | H749009881C0 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
| 9 | 00191506015084 | H7490097650 | Guidance System | AVVIGO™ Guidance System II | BOSTON SCIENTIFIC CORPORATION | |
| 10 | 00184360000709 | 806302012 | s5i Control Console | VOLCANO CORPORATION | ||
| 11 | 00184360000686 | 807401001 | s5i Imaging System Workstation | VOLCANO CORPORATION | ||
| 12 | 00184360000525 | 807301001 | s5 PC Module | VOLCANO CORPORATION | ||
| 13 | 00083059012071 | 1207 | The Aware™ Pad is intended to be used as an aid for performing breast self-examination. | Aware Breast Self-Exam Pad | BIOMERICA, INC. | |
| 14 | 00083059012033 | 1203 | The Aware™ Pad is intended to be used as an aid for performing breast self-examination. | Aware Breast Self-Exam Pad | BIOMERICA, INC. | |
| 15 | B995LI10050 | LI-1005 | Velacur is a portable ultrasonic elastography machine used to assess and monitor Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised of a control unit, activation unit, and ultrasound probe. A carrying case is also provided. | Velacur | SONIC INCYTES MEDICAL CORP. | |
| 16 | B616UVXS0 | XS | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
| 17 | B616UVXR0 | XR | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
| 18 | B616UVXP0 | XP | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
| 19 | B510DUS70000 | DUS-7000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
| 20 | B510DUS5000A1 | DUS-5000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
| 21 | B510DUS30001 | DUS-3000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
| 22 | B377GMD61VASUS40 | Vascular V4 | GMD61VASUS4 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 23 | B377GMD61ENDUS40 | Endocavity V4 | GMD61ENDUS4 | USB ultrasound probe, general purpose/endocavity. | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 24 | B377GMD61ABDUS40 | Abdominal V4 | GMD61ABDUS4 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 25 | B377GMD6180NV010 | Neonatal | GMD6180NV01 | USB ultrasound probe, general purpose/neonatal | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 26 | B377GMD6175VA010 | Vascular | GMD6175VA01 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 27 | B377GMD6175RV010 | Endocavity | GMD6175RV01 | USB ultrasound probe, general purpose/endocavity | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 28 | B377GMD6150AB010 | Abdominal 5 MHz | GMD6150AB01 | USB ultrasound probe, general use/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 29 | B377GMD6135AB020 | Abdominal 3 MHz | GMD6135AB02 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 30 | B377GMD6135AB010 | Abdominal 3.5-5 MHz | GMD6135AB01 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 31 | B377GMD6112EY01 | Ophthalmic | GMD6112EY01 | USB ultrasound probe, general purpose/ophthalmic | ClearProbe | GLOBALMEDIA GROUP, LLC |
| 32 | B3015017750001 | Model 201 | 501775000 | SonoCiné Image Acquisition Station Model 201, PN 501775000 is an accessory to ul SonoCiné Image Acquisition Station Model 201, PN 501775000 is an accessory to ultrasound imaging Systems facilitating their use as an adjunct to mammography for B-mode ultrasonic screening imaging of the breast when used with a linear array transducer consisting of the following components: Image Acquisition Station Model 201 – PN 501775-000, Image Acquisition Station Software Application V3.1.x, PN 501642, Reading Station Software Application, V3.1.x, PN 501973. | SonoCine Image Acquisition Station | SONOCINE, INC. |
| 33 | B201CGONE0 | CGONE | Clear Guide ONE | CLEAR GUIDE MEDICAL, INC. | ||
| 34 | B201CGOHM0 | CGOHM | CG-OH-M | The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. | Clear Guide Optical Head | CLEAR GUIDE MEDICAL, INC. |
| 35 | B201CGOH0 | CGOH | CG-OH | The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. | Clear Guide Optical Head | CLEAR GUIDE MEDICAL, INC. |
| 36 | B201CGCORE170 | CGCORE17 | CG-CORE17 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen. | Clear Guide CORE | CLEAR GUIDE MEDICAL, INC. |
| 37 | B118314170 | Classic | Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, an Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series. | Sonocubic 3D Ultrasound Software | MEDGE PLATFORMS INC | |
| 38 | B118314160 | Classic | Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, an Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series. | Sonocubic 3D Ultrasound Software | MEDGE PLATFORMS INC | |
| 39 | B017ED102 | EyeSeal Disposable | ED1 | ArcScan Insight 100 | ARCSCAN, INC. | |
| 40 | B017AS100 | AS100 | AS100-120 | ArcScan Insight 100 | ARCSCAN, INC. | |
| 41 | B015000010 | 00001 | Accuro | RIVANNA MEDICAL, LLC | ||
| 42 | 90814277020127 | 21-05012-01 | Sterile Transducer Cover - individual cover in envelope | Sonic Window Sterile Transducer Cover | ANALOGIC CORPORATION | |
| 43 | 90814277020028 | 10-73868-02 | Replacement unit for Sonic Window Handheld Ultrasound System | Sonic Window Handheld Ultrasound Unit | ANALOGIC CORPORATION | |
| 44 | 90814277020011 | 10-73869-01 | Docking Station for Sonic Window Handheld Ultrasound System | Sonic Window Docking Station | ANALOGIC CORPORATION | |
| 45 | 90814277020004 | 10-73690-02 | The Sonic Window is intended for the visualization of vessels and vascular acces The Sonic Window is intended for the visualization of vessels and vascular access guidance of needles and catheters (Insertion of Peripheral Intra Venous (PIV) Catheters, as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only. | Sonic Window Handheld Ultrasound System | ANALOGIC CORPORATION | |
| 46 | 60889971738837 | Touch Prime Ultrasound System | 1738830 | XE Edition | Touch Prime Ultrasound System | CARESTREAM HEALTH, INC. |
| 47 | 60889971738820 | Touch Prime Ultrasound System | 1738822 | Touch Prime Ultrasound System | Touch Prime Ultrasound System | CARESTREAM HEALTH, INC. |
| 48 | 58051887042642 | THD HRStation | 800299 | THD HRStation is an integrated proctological station mainly dedicated to the dia THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathologies of the anal canal and specifically to the diagnosis of precancerous lesions.Thanks to the THD Procto Software, it allows the proctologist to have a unique, modular and expandable diagnostic system that, in addition to the realization of high resolution anoscopy, can also allow further diagnostic investigations such as anorectal manometry and Transanal ultrasound. | THD Procto Software System | THD SPA |
| 49 | 40841716102552 | 017986 | HDi System Overpack p/n 800994-005Contents: System Console, Linear Translation S HDi System Overpack p/n 800994-005Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply | ACIST HDi® HD IVUS System | ACIST MEDICAL SYSTEMS, INC. | |
| 50 | 30856724004357 | 06-050-030 | Clear Image Singles Lite | NEXT MEDICAL PRODUCTS, LLC |