SENSOR PAD
FDA 510(k) clearance K955249 · decided 1995-12-22
Clearance details
- K-number
- K955249
- Device name
- SENSOR PAD
- Applicant
- Inventive Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-15
- Decision date
- 1995-12-22
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- IZH
- Device class
- 2
- Regulation number
- 892.1710
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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| MammoGRIP (K152038) | Women'S Imaging Solutions Enterprises, LLC | 2015-12-22 |
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| 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.