510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K132524Substantially Equivalent

CT Transcatheter Aortic Valve Implantation (Tavi) Planning Application

Philips North America LLC, Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132524 is the FDA 510(k) clearance record for CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION, a class II device, cleared for Philips Medical Systems on under FDA product code JAK (System, X-Ray, Tomography, Computed). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show one recall naming K132524.

Clearance record

Decision date
Received
(305 days to decision)
Product code
JAK System, X-Ray, Tomography, Computed
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
Philips Medical Systems 595 Miner Rd., Cleveland OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAK

Trailing 12 months
21 clearances under product code JAK in the twelve months to October 2026, March 2026 the highest month at 10.
Show the numbers
Monthly 510(k) clearances under FDA product code JAK, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 202610
April 20260
May 20261
June 20262
July 20262
August 20260
September 20264
October 20260