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FDA 510(k)

SCOPIX VIDEO IMAGER

K-Number: K882096 · 1988-08-09

ApplicantAgfa-Gevaert, Inc.
Decision Date1988-08-09
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCOPIX VIDEO IMAGER is the device name listed in this FDA 510(k) record. The listed applicant is Agfa-Gevaert, Inc.. It received FDA 510(k) clearance on 1988-08-09 under 510(k) number K882096. The device is classified under product code LMC. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCOPIX VIDEO IMAGER?

SCOPIX VIDEO IMAGER is a medical device that received FDA 510(k) clearance on 1988-08-09. The listed applicant is Agfa-Gevaert, Inc.. The 510(k) number is K882096.

When did SCOPIX VIDEO IMAGER receive FDA 510(k) clearance?

SCOPIX VIDEO IMAGER received FDA 510(k) clearance on 1988-08-09, under 510(k) number K882096.

Who is the listed applicant for SCOPIX VIDEO IMAGER?

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

What is the FDA product code for SCOPIX VIDEO IMAGER?

The FDA product code for SCOPIX VIDEO IMAGER is LMC.

Related Clinical Trials

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.

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Other records listing Agfa-Gevaert, Inc. 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.

K832603CURIX CAPACITY FILM CENTERK790273MAMMOGRAPHY SYSTEM AND CASSETTE

Related Devices (Code: LMC)

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.

K111566DRYVIEW CHROMA IMAGING SYSTEMCarestream Health, Inc.K092280CYPHER DICOM PRINT SOLUTIONVirtual Imaging, Inc.K090469CARESTREAM DRYVIEW 5850 LASER IMAGERCarestream Health, Inc.K083522SONY UP-DF750 DIGITAL FILM IMAGERSony Electronics, Inc.K081637LASER IMAGER DRYPRO MODEL 873Konica Minolta Medical & Graphic, Inc.K072680DRYSTAR AXYS, MODEL EYZ4EAgfa Healthcare Corporation

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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