510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953557Substantially Equivalent

Surgical C-Arm Table, 9610

U.S. Imaging Tables, Inc., Northport NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953557 is the FDA 510(k) clearance record for SURGICAL C-ARM TABLE, 9610, a class II device, cleared for U.S. Imaging Tables, Inc. on under FDA product code IXR (Table, Radiographic, Tilting). FDA records list 4 510(k) clearances for U.S. Imaging Tables, Inc., from to . As of , FDA records show no recalls naming K953557.

Clearance record

Decision date
Received
(71 days to decision)
Product code
IXR Table, Radiographic, Tilting
Regulation
21 CFR 892.1980
Device class
Class II
Review panel
Radiology
Applicant
U.S. Imaging Tables, Inc. 6 Bayview Ave., Northport NY
510(k) summary
Summary
Third party review
No

Clearances, product code IXR

Trailing 12 months

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

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