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
K953910Substantially Equivalent

Philips Bv 300 Series

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

K953910 is the FDA 510(k) clearance record for PHILIPS BV 300 SERIES, a class II device, cleared for Philips Medical Systems North America, Inc. on under FDA product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile). FDA's definition for product code OXO reads: "Fluoroscopy of the human body". FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show one recall naming K953910.

Clearance record

Decision date
Received
(58 days to decision)
Product code
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Regulation
21 CFR 892.1650
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 OXO

Trailing 12 months
4 clearances under product code OXO in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OXO, trailing twelve months
MonthClearances
November 20252
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260