510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K940696Substantially Equivalent

Syncra Tilt Option for Angio Diagnost 5

Philips North America LLC, Shelton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940696 is the FDA 510(k) clearance record for SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5, a class II device, cleared for Philips Medical Systems North America, Inc. on under FDA product code KXJ (Table, Radiologic). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K940696.

Clearance record

Decision date
Received
(28 days to decision)
Product code
KXJ Table, Radiologic
Regulation
21 CFR 892.1980
Device class
Class II
Review panel
Radiology
Applicant
Philips Medical Systems North America, Inc. 710 Bridgeport Ave., Shelton CT
510(k) summary
Summary
Third party review
No

Clearances, product code KXJ

Trailing 12 months

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

FDA records show no clearances under product code KXJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXJ, 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