Cleared Traditional

K130165 - PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K130165 · Advanced Planimetric Services, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
219d
Days
Class 1
Risk

K130165 is an FDA 510(k) clearance for the PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0. Classified as Tape, Camera, Surgical (product code FXN), Class I - General Controls.

Submitted by Advanced Planimetric Services, LLC (Elmwood Park, US). The FDA issued a Cleared decision on August 30, 2013 after a review of 219 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4160 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Planimetric Services, LLC devices

Submission Details

510(k) Number K130165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2013
Decision Date August 30, 2013
Days to Decision 219 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 114d · This submission: 219d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FXN Tape, Camera, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.