Affirm Prone Biopsy System
FDA 510(k) clearance K153486 · decided 2016-04-01
Clearance details
- K-number
- K153486
- Device name
- Affirm Prone Biopsy System
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-12-04
- Decision date
- 2016-04-01
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- IZH
- Device class
- 2
- Regulation number
- 892.1710
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Danbury, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SMART FINDER (K203509) | Ims Giotto S.P.A. | 2021-07-14 |
| Affirm Contrast Biopsy (K202294) | Hologic, Inc. | 2020-10-05 |
| Biopsy Positioner (K191495) | Fujifilm Corporation | 2019-07-03 |
| Affirm Lateral Arm Upright Biopsy Accessory (K161575) | Hologic | 2016-08-10 |
| Comfort Cover (K161920) | Precision Dynamics Corporation | 2016-07-15 |
| MammoGRIP (K152038) | Women'S Imaging Solutions Enterprises, LLC | 2015-12-22 |
| AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (K122836) | Lorad, A Hologic Co. | 2013-01-11 |
| SPECBOARD JR. (K123414) | Macbrud Corp., Medical Division | 2013-01-11 |
| BIOPSY DIGIT S BIOPSY SL (K113607) | Giotto USA, LLC | 2012-08-10 |
| BIOPSY POSITIONER (K113284) | Fuji Film Medical Systems | 2012-03-07 |
| AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (K103512) | Hologic, Inc. | 2011-01-07 |
| EMBRACE (K101373) | Izi Medical Products, Inc. | 2010-09-15 |
Recalls involving this device
No recalls on record reference this clearance.
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