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
K032345Substantially Equivalent

Cyberknife System for Sterotactic Radiosurgery/radiotherapy

Accuray Incorporated, Sunnyvale CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032345 is the FDA 510(k) clearance record for CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY, a class II device, cleared for Accuray, Inc. on under FDA product code MUJ (System, Planning, Radiation Therapy Treatment). FDA records list 37 510(k) clearances for Accuray Incorporated, from to . As of , FDA records show no recalls naming K032345.

Clearance record

Decision date
Received
(35 days to decision)
Product code
MUJ System, Planning, Radiation Therapy Treatment
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Accuray, Inc. 570 Del Rey Ave., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUJ

Trailing 12 months
12 clearances under product code MUJ in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MUJ, trailing twelve months
MonthClearances
November 20251
December 20253
January 20260
February 20262
March 20261
April 20260
May 20263
June 20261
July 20261
August 20260
September 20260
October 20260