PHILIPS MAMMODIAGNOST BC
FDA 510(k) clearance K913845 · decided 1991-12-20
Clearance details
- K-number
- K913845
- Device name
- PHILIPS MAMMODIAGNOST BC
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-28
- Decision date
- 1991-12-20
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- IZH
- Device class
- 2
- Regulation number
- 892.1710
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- 5680 Da Best, NL
- Third-party review
- No
- Expedited review
- No
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| 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 |
Recalls involving this device
No recalls on record reference this clearance.