510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K891292Substantially Equivalent

Srs-200 Radiosurgery System

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

K891292 is the FDA 510(k) clearance record for SRS-200 RADIOSURGERY SYSTEM, a class II device, cleared for Philips Medical Systems North America, Inc. on under FDA product code IYE (Accelerator, Linear, Medical). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K891292.

Clearance record

Decision date
Received
(192 days to decision)
Product code
IYE Accelerator, Linear, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Philips Medical Systems North America, Inc. 710 Bridgeport Ave., Shelton CT
Third party review
No

Clearances, product code IYE

Trailing 12 months
15 clearances under product code IYE in the twelve months to November 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code IYE, trailing twelve months
MonthClearances
December 20251
January 20264
February 20260
March 20261
April 20262
May 20261
June 20262
July 20260
August 20263
September 20261
October 20260
November 20260