No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05414904275535 | 5540/100 | MAVV8 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Valory | |
2 | 05414904233283 | 6011/104 | XBY1H | DR Detector | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DR 17e G |
3 | 05414904202357 | 5411/300 | 55247 | DX-D 100 - DX-D40/45 - 50 KW-300KHU-110V | IZL | System, x-ray, mobile | 2 | DX-D 100 |
4 | 05414904200704 | 6007/200 | 55SAF | DX-D 40C DETECTOR SET/A | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DX-D 40C |
5 | 05414904085714 | 5420/100 | 5RJ2R | DX-D 400 ANALOG MANUAL (D) | KPR | System, x-ray, stationary | 2 | DX-D 400 |
6 | 05414904015667 | 5367/100 | EYZ4E | DRYSTAR AXYS | LMC | Camera, multi format, radiological | 2 | DRYSTAR Axys |
7 | 05414904180389 | CR MD1.0F GENERAL PLATE 35X43 | 512HY | CR MD1.0F GEN.PL. 15X30 INS.35X43CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CR MD1.0F GENERAL PLATE |
8 | 05414904108802 | 5430/050 | 5TJOG | DX-D 600 ANALOG MANUAL SYSTEM | KPR | System, x-ray, stationary | 2 | DX-D 600 |
9 | 05414904094693 | CR MD4.0R FLFS CASSETTE 35X43 | 5R7XB | CR MD4.0R FLFS CASSETTE 35X43 CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CR MD4.0R FLFS CASSETTE |
10 | 05414904092514 | 5151/100 | 5R3EQ | CR 10-X DIGITIZER | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CR 10-X |
11 | 05414904092316 | 5430/120 | 5R2ZT | DX-D 600 AUTOMATIC SYSTEM | KPR | System, x-ray, stationary | 2 | DX-D 600 |
12 | 05414904092309 | 5430/110 | 5R2YR | DX-D 600 SEMI-AUTOMATIC SYSTEM | KPR | System, x-ray, stationary | 2 | DX-D 600 |
13 | 05414904092293 | 5430/100 | 5R2XP | DX-D 600 MANUAL SYSTEM | KPR | System, x-ray, stationary | 2 | DX-D 600 |
14 | 05414904043318 | CR MD4.0R GENERAL SR PLATE 35X43 | E5PMM | CR MD4.0R GENERALSR PLATE 35CM X 43CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CR MD4.0R GENERAL SR PLATE |
15 | 05414904043301 | CR MD4.0R GENERAL SR PLATE 35X35 | E5POQ | CR MD4.0R GENERALSR PLATE 35CM X 35CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CR MD4.0R GENERAL SR PLATE |
16 | 05414904040522 | CR HD5.0 FLFS DETECTOR 35X43 | E1WDZ | CR HD5.0 FLFS DETECTOR 35X43CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CR HD5.0 FLFS DETECTOR |
17 | 05414904037232 | AGFA CPB 200 13X18 | 347LJ | AGFA CP CASSETTE / AGFA CPB 200 | IXA | Cassette, radiographic film | 2 | AGFA CPB 200 |
18 | 05414904036969 | CR MD4.0T FLFS SET 35X43 | E2LTT | CR MD4.0T FLFS SET 35CM X 43CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CR MD4.0T FLFS SET |
19 | 05414904036693 | CURIX ORTHO REGULAR 35X35 | 3KUD1 | CURIX CAS US+OR REG 35X35 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO REGULAR |
20 | 05414904034606 | CURIX ORTHO REGULAR 30X40 | 3KN9Z | CURIX CAS EU+OR REG 30X40 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO REGULAR |
21 | 05414904034590 | CURIX ORTHO REGULAR 24X30 | 3KN8X | CURIX CAS EU+OR REG 24X30 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO REGULAR |
22 | 05414904034576 | CURIX ORTHO REGULAR 18X43 | 3KN6T | CURIX CAS EU+OR REG 18X43 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO REGULAR |
23 | 05414904034569 | CURIX ORTHO REGULAR 18X24 | 3KN5R | CURIX CAS EU+OR REG 18X24 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO REGULAR |
24 | 05414904033890 | CURIX ORTHO REGULAR 30X40 | 3KUCY | CURIX CAS US+OR REG 30X40 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO REGULAR |
25 | 05414904033883 | CURIX ORTHO REGULAR 30X35 | 3KUBW | CURIX CAS US+OR REG 30X35 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO REGULAR |
26 | 05414904033876 | CURIX ORTHO REGULAR 24X30 | 3KUAU | CURIX CAS US+OR REG 24X30 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO REGULAR |
27 | 05414904033760 | CURIX ORTHO REGULAR 18X24 | 3KT7M | CURIX CAS US+OR REG 18X24 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO REGULAR |
28 | 05414904033036 | CURIX ORTHO REGULAR 35X43 | 3KOB6 | CURIX CAS EU+OR REG 35X43 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO REGULAR |
29 | 05414904033029 | CURIX ORTHO REGULAR 35X35 | 3KOA4 | CURIX CAS EU+OR REG 35X35 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO REGULAR |
30 | 05414904026595 | CR MD4.0R FLFS SET 35X43 | E49XC | CR MD4.0R FLFS SET 35CM X 43CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CR MD4.0R FLFS SET |
31 | 05414904009345 | MAMORAY HD 24X30 | EDBU7 | MAMORAY CASSETTE / HD | IZH | System, x-ray, mammographic | 2 | MAMORAY HD |
32 | 05414904008898 | MAMORAY HD 18X24 | EDBQY | MAMORAY CASSETTE / HD | IZH | System, x-ray, mammographic | 2 | MAMORAY HD |
33 | 05414904008881 | MAMORAY HD 18X24 | EDBR1 | MAMORAY CASSETTE / HD | IZH | System, x-ray, mammographic | 2 | MAMORAY HD |
34 | 05414904006511 | CURIX ORTHO REGULAR 15X30 | 38XZ8 | CURIX CAS EU+OR REG 15X30 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO REGULAR |
35 | 05414904271124 | 2.0 | E5C34 | Software | LLZ | System, image processing, radiological | 2 | SE Suite |
36 | 05414904222218 | 5400/524 | XBOPM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DR 14S G DX-D IMAGING PACKAGE | |
37 | 05414904094686 | CR MD4.0R GENERAL CASSETTE 15X30 | 5R7W8 | CR MD4.0R GENERAL CASSETTE 15X30 CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CR MD4.0R GENERAL CASSETTE |
38 | 05414904094679 | CR MD4.0R GENERAL CASSETTE 18X24 | 5R7V6 | CR MD4.0R GENERAL CASSETTE 18X24 CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CR MD4.0R GENERAL CASSETTE |
39 | 05414904094662 | CR MD4.0R GENERAL CASSETTE 24X30 | 5R7U4 | CR MD4.0R GENERAL CASSETTE 24X30 CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CR MD4.0R GENERAL CASSETTE |
40 | 05414904094655 | CR MD4.0R GENERAL CASSETTE 35X35 | 5R7T2 | CR MD4.0R GENERAL CASSETTE 35X35 CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CR MD4.0R GENERAL CASSETTE |
41 | 05414904094631 | CR MD4.0R GENERAL CASSETTE 35X43 | 5R7RX | CR MD4.0R GENERAL CASSETTE 35X43 CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CR MD4.0R GENERAL CASSETTE |
42 | 05414904040539 | CR HD5.0 FLFS CASSETTE 35X43 | E1WE2 | CR HD5.0 FLFS CASSETTE 35X43CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CR HD5.0 FLFS CASSETTE |
43 | 05414904039564 | CURIX ORTHO FAST 30X35 | 3KUY8 | CURIX CAS US+OR FAST 30X35 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO FAST |
44 | 05414904039557 | CURIX ORTHO FAST 24X30 | 3KUX6 | CURIX CAS US+OR FAST 24X30 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO FAST |
45 | 05414904039533 | CURIX ORTHO FAST 18X43 | 3KUV2 | CURIX CAS US+OR FAST 18X43 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO FAST |
46 | 05414904033845 | CURIX ORTHO FAST 8X10 | 3KU3H | CURIX CAS US+OR FAST 8X10 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO FAST |
47 | 05414904033838 | CURIX ORTHO FAST 35X43 | 3KU2F | CURIX CAS US+OR FAST 35X43 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO FAST |
48 | 05414904033821 | CURIX ORTHO FAST 35X35 | 3KU1D | CURIX CAS US+OR FAST 35X35 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO FAST |
49 | 05414904033364 | CURIX ORTHO FAST 35X43 | 3KOS5 | CURIX CAS EU+OR FAST 35X43 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO FAST |
50 | 05414904033081 | CURIX ORTHO FAST 30X40 | 3KOQ1 | CURIX CAS EU+OR FAST 30X40 | IXA | Cassette, radiographic film | 2 | CURIX ORTHO FAST |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B852SPECBOARD4440 | 444 | Device Classification Name System, X-Ray, Mammographic510(K) Number K891090 | Specboard | MACBRUD CORPORATION | |
2 | B852SPECBOARD2220 | 222 | Device Classification Name System, X-Ray, Mammographic510(K) Number K123414Devic Device Classification Name System, X-Ray, Mammographic510(K) Number K123414Device Name SPECBOARD JR. | SPECBOARD JR | MACBRUD CORPORATION | |
3 | 45420045505811 | MP301-T | MP301-T | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
4 | 45420045505804 | MP301-D | MP301-D | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
5 | 45420045505798 | MP301 | MP301 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
6 | 45420045505781 | MP201 | MP201 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
7 | 45420045505668 | MP101 | MP101 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
8 | 30382904094097 | 409409 | 409409 | NEEDLE BIOPSY S/SU 20GA 1-1/2IN BREAST | BD PrecisionGlide | BECTON, DICKINSON AND COMPANY |
9 | 30382904094080 | 409408 | 409408 | NEEDLE BIOPSY S/SU 20GA 2-1/2IN BREAST | BD PrecisionGlide | BECTON, DICKINSON AND COMPANY |
10 | 30382904094073 | 409407 | 409407 | NEEDLE BIOPSY S/SU 20GA 3-1/2IN BREAST | BD PrecisionGlide | BECTON, DICKINSON AND COMPANY |
11 | 25420045507347 | MP201-10 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | ||
12 | 25420045507330 | MP301-10 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | ||
13 | 25420045506951 | MP301-T | MP301-T | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
14 | 25420045506944 | MP301-D | MP301-D | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
15 | 15420045512948 | AFFIRM™ CONTRAST BIOPSY SOFTWARE | AFFIRM™ CONTRAST BIOPSY | HOLOGIC, INC. | ||
16 | 15420045512931 | AFFIRM™ SPECIMEN IMAGING | AFFIRM™ SPECIMEN IMAGING | HOLOGIC, INC. | ||
17 | 15420045510869 | PBX-SYS-AFFIRM-2D | PBX-SYS-AFFIRM-2D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
18 | 15420045510852 | PBX-SYS-AFFIRM-2D | PBX-SYS-AFFIRM-2D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
19 | 15420045510845 | PBX-SYS-AFFIRM-2D | PBX-SYS-AFFIRM-2D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
20 | 15420045507197 | ASY-03669 | ASY-03669 | Affirm Breast Biopsy Guidance System | HOLOGIC, INC. | |
21 | 15420045507180 | ASY-03668 | ASY-03668 | Affirm Breast Biopsy Guidance System | HOLOGIC, INC. | |
22 | 15420045507173 | ASY-03667 | ASY-03667 | Affirm Breast Biopsy Guidance System | HOLOGIC, INC. | |
23 | 15420045506831 | ASY-05205 | ASY-05205 | Affirm Lateral Arm Upright Biopsy Accessory | HOLOGIC, INC. | |
24 | 15420045506824 | ASY-09644 | ASY-09644 | Affirm Lateral Arm Upright Biopsy Accessory | HOLOGIC, INC. | |
25 | 15420045506817 | ASY-03723 | ASY-03723 | Affirm Lateral Arm Upright Biopsy Accessory | HOLOGIC, INC. | |
26 | 15420045506541 | ASY-09175 | ASY-09175 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
27 | 15420045506534 | ASY-08832 | ASY-08832 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
28 | 15420045506527 | ASY-06886 | ASY-06886 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
29 | 15420045506510 | PBX-SYS-AFFIRM-3D | PBX-SYS-AFFIRM-3D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
30 | 15420045506503 | PBX-SYS-AFFIRM-2D | PBX-SYS-AFFIRM-2D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
31 | 15420045506497 | ASY-08178 | ASY-08178 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
32 | 15420045506480 | ASY-08176 | ASY-08176 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
33 | 15420045506473 | ASY-08175 | ASY-08175 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
34 | 15420045506466 | ASY-08174 | ASY-08174 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
35 | 15420045506077 | 3-000-2247 | 3-000-2247 | Digital Spot Mammography System, DSM | HOLOGIC, INC. | |
36 | 15420045505926 | 8-004-0017 | 8-004-0017 | Multicare Platinum | HOLOGIC, INC. | |
37 | 15420045505858 | STLC-00004 | STLC-00004 | Affirm Breast Biopsy Guidance System | HOLOGIC, INC. | |
38 | 15420045504738 | 3D System Software | Affirm Prone Biopsy System | HOLOGIC, INC. | ||
39 | 15420045504721 | System Software | Affirm Prone Biopsy System | HOLOGIC, INC. | ||
40 | 08033837190301 | MAMMOBED | 6100-06M1 | It's a special table on wheels for stereotactic breast biopsy procedures with pa It's a special table on wheels for stereotactic breast biopsy procedures with patient in prone position. | MAMMOBED | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL |
41 | 08033837190219 | BIOPSY DIGIT AM | 9100-01 | Biopsy Digit device uses two stereo images taken by a digital solid state camera Biopsy Digit device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. It is intended to mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement. | BIOPSY DIGIT | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL |
42 | 08033837190202 | BIOPSY DIGIT SL | 9201-01 | Biopsy Digit SL is a medical device intended to be used for mamnmographic proced Biopsy Digit SL is a medical device intended to be used for mamnmographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement. | BIOPSY DIGIT | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL |
43 | 08033837190110 | GIOTTO IMAGE SRA | 6702 | Giotto Image is a conventional film-screen x-ray mammographic device. | GIOTTO IMAGE | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL |
44 | 08033837190103 | GIOTTO IMAGE M | 6501 | Giotto Image is a conventional film-screen x-ray mammographic device. | GIOTTO IMAGE | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL |
45 | 07613327059281 | 0502513045 | 0502-513-045 | HD Bariatric Laparoscope, Autoclavable, 45 ¿ View Direction | Precision Ideal Eyes | STRYKER CORPORATION |
46 | 07613327059243 | 0502513010 | 0502-513-010 | HD Bariatric Laparoscope, Autoclavable, 0 ¿ View Direction | Precision Ideal Eyes | STRYKER CORPORATION |
47 | 07613327059182 | 0502513030 | 0502-513-030 | HD Bariatric Laparoscope, Autoclavable, 30 ¿ View Direction | Precision Ideal Eyes | STRYKER CORPORATION |
48 | 06430035430055 | Sophie Classic | Planmed Sophie Classic is a mammographic x-ray unit intended for diagnosis of br Planmed Sophie Classic is a mammographic x-ray unit intended for diagnosis of breast cancer. | Planmed | PLANMED OY | |
49 | 05414904009802 | MAMORAY HD 24X30 | EDBVA | MAMORAY CASSETTE / HD | MAMORAY HD | AGFA |
50 | 05414904009796 | MAMORAY HD S 18X24 | EDBZJ | MAMORAY CASSETTE / HD S | MAMORAY HD S | AGFA |