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FDA 510(k)

COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION

K-Number: K053634 · 2006-01-17

ApplicantAgfa Corporation
Decision Date2006-01-17
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Corporation. It received FDA 510(k) clearance on 2006-01-17 under 510(k) number K053634. 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 COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION?

COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION is a medical device that received FDA 510(k) clearance on 2006-01-17. The listed applicant is Agfa Corporation. The 510(k) number is K053634.

When did COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION receive FDA 510(k) clearance?

COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION received FDA 510(k) clearance on 2006-01-17, under 510(k) number K053634.

Who is the listed applicant for COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION?

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

What is the FDA product code for COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION?

The FDA product code for COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION is MQB.

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Other records listing Agfa Corporation 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.

K062742CR 85-XK062223AGFA MODEL CR30-XK052251DRYSTAR MODEL 5500

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

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

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