510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893690Substantially Equivalent

Super Speed Potter-Bucky (Eso5-110 & 220)

Hofmann X-Ray of America, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893690 is the FDA 510(k) clearance record for SUPER SPEED POTTER-BUCKY (ESO5-110 & 220), a class II device, cleared for Hofmann X-Ray of America, Inc. on under FDA product code IXQ (Table, Radiographic, Stationary Top). FDA records list 2 510(k) clearances for Hofmann X-Ray of America, Inc., from to . As of , FDA records show no recalls naming K893690.

Clearance record

Decision date
Received
(65 days to decision)
Product code
IXQ Table, Radiographic, Stationary Top
Regulation
21 CFR 892.1980
Device class
Class II
Review panel
Radiology
Applicant
Hofmann X-Ray of America, Inc. 16540 Aston St., Irvine CA
Third party review
No

Clearances, product code IXQ

Trailing 12 months

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

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