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FDA 510(k)

DX-SI

K-Number: K063421 · 2006-11-22

ApplicantAgfa Corp.
Decision Date2006-11-22
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DX-SI is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Corp.. It received FDA 510(k) clearance on 2006-11-22 under 510(k) number K063421. 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 DX-SI?

DX-SI is a medical device that received FDA 510(k) clearance on 2006-11-22. The listed applicant is Agfa Corp.. The 510(k) number is K063421.

When did DX-SI receive FDA 510(k) clearance?

DX-SI received FDA 510(k) clearance on 2006-11-22, under 510(k) number K063421.

Who is the listed applicant for DX-SI?

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 DX-SI?

The FDA product code for DX-SI 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.

K053458WEB1000K050810AGFA CR50.0K050751IMPAX 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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