510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891395Substantially Equivalent

Radkor Bs-10 and Bs-10T

Radkor, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891395 is the FDA 510(k) clearance record for RADKOR BS-10 AND BS-10T, a class I device, cleared for Radkor, Inc. on under FDA product code IXY (Holder, Radiographic Cassette, Wall-Mounted). FDA records list 10 510(k) clearances for Radkor, Inc., from to . As of , FDA records show no recalls naming K891395.

Clearance record

Decision date
Received
(20 days to decision)
Product code
IXY Holder, Radiographic Cassette, Wall-Mounted
Regulation
21 CFR 892.1880
Device class
Class I
Review panel
Radiology
Applicant
Radkor, Inc. 16610 Aston St., Irvine CA
Third party review
No

Clearances, product code IXY

Trailing 12 months

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

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