510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833523Substantially Equivalent

C.b. Radiology Design Gonadshield

Radiology Design, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833523 is the FDA 510(k) clearance record for C.B. RADIOLOGY DESIGN GONADSHIELD, a class I device, cleared for Radiology Design on under FDA product code IWT (Shield, Gonadal). FDA records list one 510(k) clearance for Radiology Design. As of , FDA records show no recalls naming K833523.

Clearance record

Decision date
Received
(62 days to decision)
Product code
IWT Shield, Gonadal
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Applicant
Radiology Design 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IWT

Trailing 12 months

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

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