510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K934574Substantially Equivalent

Model Mpft-01, Genesis

International Medical Designs, Inc., Deltona FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934574 is the FDA 510(k) clearance record for MODEL MPFT-01, GENESIS, a class II device, cleared for International Medical Designs, Inc. on under FDA product code IXR (Table, Radiographic, Tilting). FDA records list 2 510(k) clearances for International Medical Designs, Inc., from to . As of , FDA records show no recalls naming K934574.

Clearance record

Decision date
Received
(169 days to decision)
Product code
IXR Table, Radiographic, Tilting
Regulation
21 CFR 892.1980
Device class
Class II
Review panel
Radiology
Applicant
International Medical Designs, Inc. 303 Elnora Ave., Deltona FL
510(k) summary
Statement
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