510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K944987Substantially Equivalent

Uro - Elite Table Accessories

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

K944987 is the FDA 510(k) clearance record for URO - ELITE TABLE ACCESSORIES, a class II device, cleared for Philips Medical Systems (Cleveland), Inc. on under FDA product code IXR (Table, Radiographic, Tilting). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K944987.

Clearance record

Decision date
Received
(49 days to decision)
Product code
IXR Table, Radiographic, Tilting
Regulation
21 CFR 892.1980
Device class
Class II
Review panel
Radiology
Applicant
Philips Medical Systems (Cleveland), Inc. 595 Miner Rd., Cleveland OH
510(k) summary
Summary
Third party review
No

Clearances, product code IXR

Trailing 12 months

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

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