Clearance Summary
PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 received FDA 510(k) clearance under submission number K130165, sponsored by Advanced Planimetric Services, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2013-08-30.
- Submission: K130165
- Applicant / Sponsor: Advanced Planimetric Services, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4160
- Decision date: 2013-08-30
Classification & Regulation
This clearance is catalogued under FDA product code FXN and 21 CFR 878.4160, within the General, Plastic Surgery review panel as a Class I device.