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FDA 510(k)

AGFA CR50.0

K-Number: K050810 · 2005-04-21

ApplicantAgfa Corp.
Decision Date2005-04-21
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AGFA CR50.0 is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Corp.. It received FDA 510(k) clearance on 2005-04-21 under 510(k) number K050810. 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 AGFA CR50.0?

AGFA CR50.0 is a medical device that received FDA 510(k) clearance on 2005-04-21. The listed applicant is Agfa Corp.. The 510(k) number is K050810.

When did AGFA CR50.0 receive FDA 510(k) clearance?

AGFA CR50.0 received FDA 510(k) clearance on 2005-04-21, under 510(k) number K050810.

Who is the listed applicant for AGFA CR50.0?

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 AGFA CR50.0?

The FDA product code for AGFA CR50.0 is MQB.

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.XK042779RADIOTHERAPY SOLUTION BASED ON CRK041701AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEMK040555IMPAX 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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