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FDA 510(k)

AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM

K-Number: K041701 · 2004-07-22

ApplicantAgfa Corp.
Decision Date2004-07-22
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Corp.. It received FDA 510(k) clearance on 2004-07-22 under 510(k) number K041701. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM?

AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2004-07-22. The listed applicant is Agfa Corp.. The 510(k) number is K041701.

When did AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM receive FDA 510(k) clearance?

AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM received FDA 510(k) clearance on 2004-07-22, under 510(k) number K041701.

Who is the listed applicant for AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM?

The FDA 510(k) record lists Agfa Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM?

The FDA product code for AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM is MQB.

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Other records listing Agfa Corp. 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.

K063421DX-SIK053458WEB1000K050751IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.XK050810AGFA CR50.0K042779RADIOTHERAPY SOLUTION BASED ON CRK040555IMPAX CLIENT EMBRACE

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Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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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