510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921501Substantially Equivalent

Deluxe C Arm Radiological Table, Model #056-004

Biodan Medical Systems, Ltd., Shirley NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921501 is the FDA 510(k) clearance record for DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004, a class II device, cleared for Biodan Medical Systems, Ltd. on under FDA product code IZZ (Table, Radiographic, Non-Tilting, Powered). FDA records list 20 510(k) clearances for Biodan Medical Systems, Ltd., from to . As of , FDA records show no recalls naming K921501.

Clearance record

Decision date
Received
(45 days to decision)
Product code
IZZ Table, Radiographic, Non-Tilting, Powered
Regulation
21 CFR 892.1980
Device class
Class II
Review panel
Radiology
Applicant
Biodan Medical Systems, Ltd. Brookhave R & D Plz., Shirley NY
510(k) summary
Statement
Third party review
No

Clearances, product code IZZ

Trailing 12 months

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

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