510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K984111Substantially Equivalent

Fv-RF

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

K984111 is the FDA 510(k) clearance record for FV-RF, a class II device, cleared for Philips Medical Systems (Cleveland), Inc. on under FDA product code KPR (System, X-Ray, Stationary). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show one recall naming K984111.

Clearance record

Decision date
Received
(24 days to decision)
Product code
KPR System, X-Ray, Stationary
Regulation
21 CFR 892.1680
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 KPR

Trailing 12 months
7 clearances under product code KPR in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20262
September 20261
October 20260