510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000478Substantially Equivalent

The Cyberknife System for Stereotactic Radiosurgery/ Radiotherapy V2.1

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

K000478 is the FDA 510(k) clearance record for THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1, a class II device, cleared for Accuray, Inc. on under FDA product code IWB (System, Radiation Therapy, Radionuclide). FDA records list 37 510(k) clearances for Accuray Incorporated, from to . As of , FDA records show no recalls naming K000478.

Clearance record

Decision date
Received
(65 days to decision)
Product code
IWB System, Radiation Therapy, Radionuclide
Regulation
21 CFR 892.5750
Device class
Class II
Review panel
Radiology
Applicant
Accuray, Inc. 570 Del Rey Ave., Sunnyvale CA
510(k) summary
Summary
Third party review
No

Clearances, product code IWB

Trailing 12 months

FDA records hold no clearances under product code IWB in the trailing twelve months.

FDA records show no clearances under product code IWB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260