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FDA 510(k)

AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO

K-Number: K000159 · 2000-02-16

ApplicantAgfa Corp.
Decision Date2000-02-16
Product CodeIXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Corp.. It received FDA 510(k) clearance on 2000-02-16 under 510(k) number K000159. 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 AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO?

AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO is a medical device that received FDA 510(k) clearance on 2000-02-16. The listed applicant is Agfa Corp.. The 510(k) number is K000159.

When did AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO receive FDA 510(k) clearance?

AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO received FDA 510(k) clearance on 2000-02-16, under 510(k) number K000159.

Who is the listed applicant for AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO?

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 DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO?

The FDA product code for AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO is IXK.

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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-SIK053458WEB1000K050810AGFA CR50.0K050751IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.XK042779RADIOTHERAPY SOLUTION BASED ON CRK041701AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM

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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.K032654PORT CASSETTEOrex Computed Radiography, Ltd.K003689CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31Canon USA, Inc.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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