510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K032654Substantially Equivalent

Port Cassette

Orex Computed Radiography, Ltd., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032654 is the FDA 510(k) clearance record for PORT CASSETTE, a class II device, cleared for Orex Computed Radiography, Ltd. on under FDA product code IXK (System, Imaging, X-Ray, Electrostatic). FDA records list 3 510(k) clearances for Orex Computed Radiography, Ltd., from to . As of , FDA records show no recalls naming K032654.

Clearance record

Decision date
Received
(42 days to decision)
Product code
IXK System, Imaging, X-Ray, Electrostatic
Regulation
21 CFR 892.1630
Device class
Class II
Review panel
Radiology
Applicant
Orex Computed Radiography, Ltd. 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IXK

Trailing 12 months

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

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