510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K874558Substantially Equivalent

Sl Series, Sl 15, 18, 20 & 25

Philips North America LLC, 5680 Da Best, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874558 is the FDA 510(k) clearance record for SL SERIES, SL 15, 18, 20 & 25, a class II device, cleared for Philips Medical Systems, 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 K874558.

Clearance record

Decision date
Received
(180 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, Inc. Veenpluis 4-6, 5680 Da Best, NL
Third party review
No

Clearances, product code IYE

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