510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K935615Substantially Equivalent

Medical Linear Accelerator

Accelerator Systems Intl., Inc., Milpitas CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935615 is the FDA 510(k) clearance record for MEDICAL LINEAR ACCELERATOR, a class II device, cleared for Accelerator Systems Intl., Inc. on under FDA product code IYE (Accelerator, Linear, Medical). FDA records list one 510(k) clearance for Accelerator Systems Intl., Inc. As of , FDA records show no recalls naming K935615.

Clearance record

Decision date
Received
(564 days to decision)
Product code
IYE Accelerator, Linear, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Accelerator Systems Intl., Inc. 552 Gibraltar Ave., Milpitas CA
510(k) summary
Statement
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