510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914821Substantially Equivalent

Crs Radiation Beam Scanner

Consolidated Radiation Services, Inc., Vero Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914821 is the FDA 510(k) clearance record for CRS RADIATION BEAM SCANNER, a class II device, cleared for Consolidated Radiation Services, Inc. on under FDA product code IYI (Collimator, Orthovoltage, Therapeutic X-Ray). FDA records list one 510(k) clearance for Consolidated Radiation Services, Inc. As of , FDA records show no recalls naming K914821.

Clearance record

Decision date
Received
(419 days to decision)
Product code
IYI Collimator, Orthovoltage, Therapeutic X-Ray
Regulation
21 CFR 892.5900
Device class
Class II
Review panel
Radiology
Applicant
Consolidated Radiation Services, Inc. 140 Sopwith Dr., Vero Beach FL
510(k) summary
Summary
Third party review
No

Clearances, product code IYI

Trailing 12 months

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

FDA records show no clearances under product code IYI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IYI, 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