No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 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. | IZH | System, X-Ray, Mammographic | 2 | BIOPSY DIGIT |
2 | 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. | IZH | System, X-Ray, Mammographic | 2 | BIOPSY DIGIT |
3 | 08033837190059 | GIOTTO IMAGE_21'' 2Mpixel | 6902 | GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereo GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereotactic biopsy. | MUE | Full Field Digital,System,X-Ray,Mammographic | 2 | GIOTTO IMAGE 3DL |
4 | 08033837190042 | GIOTTO IMAGE_20'' 2Mpixel | 6907 | GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereo GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereotactic biopsy. | MUE | Full Field Digital,System,X-Ray,Mammographic | 2 | GIOTTO IMAGE 3DL |
5 | 08033837190035 | MAW | 6006-15GM3 | MAW is a Management & Acquisition Workstation with 21" LCD 2Mpixel monitor, dedi MAW is a Management & Acquisition Workstation with 21" LCD 2Mpixel monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner. | MUE | Full Field Digital,System,X-Ray,Mammographic | GIOTTO IMAGE 3DL | |
6 | 08033837190028 | Amorphous Selenium detector | D75 | It's an amorphous selenium detector 24 x 30 cm that directly captures x-rays and It's an amorphous selenium detector 24 x 30 cm that directly captures x-rays and converts the them into electronic signal from which the images are constructed. | MUE | Full Field Digital,System,X-Ray,Mammographic | 2 | GIOTTO IMAGE 3DL |
7 | 08033837190011 | GIOTTO IMAGE_20'' 3Mpixel | 6909 | GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereo GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereotactic biopsy. | MUE | Full Field Digital,System,X-Ray,Mammographic | 2 | GIOTTO IMAGE 3DL |
8 | 08033837190110 | GIOTTO IMAGE SRA | 6702 | Giotto Image is a conventional film-screen x-ray mammographic device. | IZH | System, X-Ray, Mammographic | 2 | GIOTTO IMAGE |
9 | 08033837190103 | GIOTTO IMAGE M | 6501 | Giotto Image is a conventional film-screen x-ray mammographic device. | IZH | System, X-Ray, Mammographic | GIOTTO IMAGE |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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 | |
2 | 05414904009802 | MAMORAY HD 24X30 | EDBVA | MAMORAY CASSETTE / HD | MAMORAY HD | AGFA |
3 | 05414904009796 | MAMORAY HD S 18X24 | EDBZJ | MAMORAY CASSETTE / HD S | MAMORAY HD S | AGFA |
4 | 05414904009345 | MAMORAY HD 24X30 | EDBU7 | MAMORAY CASSETTE / HD | MAMORAY HD | AGFA |
5 | 05414904008966 | MAMORAY HD S 18X24 | EDB1L | MAMORAY CASSETTE / HD S | MAMORAY HD S | AGFA |
6 | 05414904008959 | MAMORAY HD S 24X30 | EDB3P | MAMORAY CASSETTE / HD S | MAMORAY HD S | AGFA |
7 | 05414904008942 | MAMORAY HD S 24X30 | EDB4R | MAMORAY CASSETTE / HD S | MAMORAY HD S | AGFA |
8 | 05414904008898 | MAMORAY HD 18X24 | EDBQY | MAMORAY CASSETTE / HD | MAMORAY HD | AGFA |
9 | 05414904008881 | MAMORAY HD 18X24 | EDBR1 | MAMORAY CASSETTE / HD | MAMORAY HD | AGFA |
10 | 00841911101581 | MMT100 | Stereotactic X-Ray Breast Biopsy Table System | Mammotome MammoTest | DEVICOR MEDICAL PRODUCTS, INC. | |
11 | 00840682123297 | EST6 | Senographe Essential Stereotaxy | GE MEDICAL SYSTEMS | ||
12 | 00815137021251 | 311S | Protective Coverlets for Mammography - 29.2cm x 33.0cm | Bella Blankets | BEEKLEY CORPORATION | |
13 | 00815137021244 | 310S | Protective Coverlets for Mammography - 22.9cm x 27.9cm | Bella Blankets | BEEKLEY CORPORATION | |
14 | 00815137020247 | 311 | Protective Coverlets for Mammography - 29.2cm x 33.0cm | Bella Blankets | BEEKLEY CORPORATION | |
15 | 00815137020230 | 310 | Protective Coverlets for Mammography - 22.9cm x 27.9cm | Bella Blankets | BEEKLEY CORPORATION | |
16 | 00813079020424 | LNGO-2022 | LNGO-2022 | 20/22ga (0.9/0.7mm) | Open Needle Guide | REMINGTON MEDICAL, INC. |
17 | 00813079020417 | LNGC-2022 | LNGC-2022 | 20/22ga (0.9/0.7mm) | Closed Needle Guide | REMINGTON MEDICAL, INC. |
18 | 00813079020400 | LNGC-14 | LNGC-14 | 14ga (2.1mm) | Closed Needle Guide | REMINGTON MEDICAL, INC. |
19 | B852SPECBOARD4440 | 444 | Device Classification Name System, X-Ray, Mammographic510(K) Number K891090 | Specboard | MACBRUD CORPORATION | |
20 | 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 | |
21 | 45420045505811 | MP301-T | MP301-T | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
22 | 45420045505804 | MP301-D | MP301-D | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
23 | 45420045505798 | MP301 | MP301 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
24 | 45420045505781 | MP201 | MP201 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
25 | 45420045505668 | MP101 | MP101 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
26 | 30382904094097 | 409409 | 409409 | NEEDLE BIOPSY S/SU 20GA 1-1/2IN BREAST | BD PrecisionGlide | BECTON, DICKINSON AND COMPANY |
27 | 30382904094080 | 409408 | 409408 | NEEDLE BIOPSY S/SU 20GA 2-1/2IN BREAST | BD PrecisionGlide | BECTON, DICKINSON AND COMPANY |
28 | 30382904094073 | 409407 | 409407 | NEEDLE BIOPSY S/SU 20GA 3-1/2IN BREAST | BD PrecisionGlide | BECTON, DICKINSON AND COMPANY |
29 | 25420045507347 | MP201-10 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | ||
30 | 25420045507330 | MP301-10 | MammoPad Radiolucent Cushion | HOLOGIC, INC. | ||
31 | 25420045506951 | MP301-T | MP301-T | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
32 | 25420045506944 | MP301-D | MP301-D | MammoPad Radiolucent Cushion | HOLOGIC, INC. | |
33 | 15420045512948 | AFFIRM™ CONTRAST BIOPSY SOFTWARE | AFFIRM™ CONTRAST BIOPSY | HOLOGIC, INC. | ||
34 | 15420045512931 | AFFIRM™ SPECIMEN IMAGING | AFFIRM™ SPECIMEN IMAGING | HOLOGIC, INC. | ||
35 | 15420045510869 | PBX-SYS-AFFIRM-2D | PBX-SYS-AFFIRM-2D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
36 | 15420045510852 | PBX-SYS-AFFIRM-2D | PBX-SYS-AFFIRM-2D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
37 | 15420045510845 | PBX-SYS-AFFIRM-2D | PBX-SYS-AFFIRM-2D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
38 | 15420045507197 | ASY-03669 | ASY-03669 | Affirm Breast Biopsy Guidance System | HOLOGIC, INC. | |
39 | 15420045507180 | ASY-03668 | ASY-03668 | Affirm Breast Biopsy Guidance System | HOLOGIC, INC. | |
40 | 15420045507173 | ASY-03667 | ASY-03667 | Affirm Breast Biopsy Guidance System | HOLOGIC, INC. | |
41 | 15420045506831 | ASY-05205 | ASY-05205 | Affirm Lateral Arm Upright Biopsy Accessory | HOLOGIC, INC. | |
42 | 15420045506824 | ASY-09644 | ASY-09644 | Affirm Lateral Arm Upright Biopsy Accessory | HOLOGIC, INC. | |
43 | 15420045506817 | ASY-03723 | ASY-03723 | Affirm Lateral Arm Upright Biopsy Accessory | HOLOGIC, INC. | |
44 | 15420045506541 | ASY-09175 | ASY-09175 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
45 | 15420045506534 | ASY-08832 | ASY-08832 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
46 | 15420045506527 | ASY-06886 | ASY-06886 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
47 | 15420045506510 | PBX-SYS-AFFIRM-3D | PBX-SYS-AFFIRM-3D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
48 | 15420045506503 | PBX-SYS-AFFIRM-2D | PBX-SYS-AFFIRM-2D | Affirm Prone Biopsy System | HOLOGIC, INC. | |
49 | 15420045506497 | ASY-08178 | ASY-08178 | Affirm Prone Biopsy System | HOLOGIC, INC. | |
50 | 15420045506480 | ASY-08176 | ASY-08176 | Affirm Prone Biopsy System | HOLOGIC, INC. |