ISO-MAMMO
FDA 510(k) clearance K860129 · decided 1986-03-06
Clearance details
- K-number
- K860129
- Device name
- ISO-MAMMO
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-14
- Decision date
- 1986-03-06
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- IZH
- Device class
- 2
- Regulation number
- 892.1710
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Highland Heights, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Philips Medical Systems (Cleveland)
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| Affirm Prone Biopsy System (K153486) | Hologic, Inc. | 2016-04-01 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S019) | Philips Medical Systems (Cleveland), Inc. | 1988-07-27 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S022) | Philips Medical Systems (Cleveland), Inc. | 1988-07-14 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S021) | Philips Medical Systems (Cleveland), Inc. | 1988-07-14 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S018) | Philips Medical Systems (Cleveland), Inc. | 1988-06-13 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S017) | Philips Medical Systems (Cleveland), Inc. | 1988-05-16 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S015) | Philips Medical Systems (Cleveland), Inc. | 1988-05-16 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S016) | Philips Medical Systems (Cleveland), Inc. | 1988-04-28 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S014) | Philips Medical Systems (Cleveland), Inc. | 1988-04-26 |