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FDA 510(k)

PORT CASSETTE

K-Number: K032654 · 2003-10-09

ApplicantOrex Computed Radiography, Ltd.
Decision Date2003-10-09
Product CodeIXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PORT CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Orex Computed Radiography, Ltd.. It received FDA 510(k) clearance on 2003-10-09 under 510(k) number K032654. The device is classified under product code IXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORT CASSETTE?

PORT CASSETTE is a medical device that received FDA 510(k) clearance on 2003-10-09. The listed applicant is Orex Computed Radiography, Ltd.. The 510(k) number is K032654.

When did PORT CASSETTE receive FDA 510(k) clearance?

PORT CASSETTE received FDA 510(k) clearance on 2003-10-09, under 510(k) number K032654.

Who is the listed applicant for PORT CASSETTE?

The FDA 510(k) record lists Orex Computed Radiography, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORT CASSETTE?

The FDA product code for PORT CASSETTE is IXK.

Related Clinical Trials

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Other records listing Orex Computed Radiography, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K073670KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260K003256PCCR DIGITAL IMAGING DEVICE

Related Devices (Code: IXK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093640DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRAElectron Jsco.K072766PVMED DDR 2520 DIGITAL IMAGING SYSTEMPortavision MedicalK042779RADIOTHERAPY SOLUTION BASED ON CRAgfa Corp.K003689CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31Canon USA, Inc.K000159AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLOAgfa Corp.K942561FUJI FCR IMAGE PROCESSING UNIT IP-U515Fujifilm Medical System U.S.A., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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