PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0
FDA 510(k) clearance K130165 · decided 2013-08-30
Clearance details
- K-number
- K130165
- Device name
- PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0
- Applicant
- Advanced Planimetric Services, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-01-23
- Decision date
- 2013-08-30
- Days to decision
- 219 days
- Clearance type
- Traditional
- Product code
- FXN
- Device class
- 1
- Regulation number
- 878.4160
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Elmwood Park, NJ, 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 |
|---|---|---|
| WOUND MEASURING & MONITORING DEVICE (K131596) | Woundvision, LLC | 2013-12-11 |
| SILHOUETTE, MODEL 1000.01 (K070426) | Aranz Medical Limited | 2007-06-29 |
| VERGE VIDEOMETER (K962148) | Verg, Inc. | 1996-12-20 |
Recalls involving this device
No recalls on record reference this clearance.