510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130165Substantially Equivalent

Pictzar Digital Planimetry Software Application 7.0

Advanced Planimetric Services, LLC, Elmwood Park NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130165 is the FDA 510(k) clearance record for PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0, a class I device, cleared for Advanced Planimetric Services, LLC on under FDA product code FXN (Tape, Camera, Surgical). FDA records list one 510(k) clearance for Advanced Planimetric Services, LLC. As of , FDA records show no recalls naming K130165.

Clearance record

Decision date
Received
(219 days to decision)
Product code
FXN Tape, Camera, Surgical
Regulation
21 CFR 878.4160
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Advanced Planimetric Services, LLC 610 Blvd., Elmwood Park NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FXN

Trailing 12 months

FDA records hold no clearances under product code FXN in the trailing twelve months.

FDA records show no clearances under product code FXN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FXN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260