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FDA 510(k)

MODIFICATION TO LR 5200 FILM RECORDER

K-Number: K012010 · 2001-09-20

ApplicantAgfa Corp.
Decision Date2001-09-20
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LR 5200 FILM RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Corp.. It received FDA 510(k) clearance on 2001-09-20 under 510(k) number K012010. 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 MODIFICATION TO LR 5200 FILM RECORDER?

MODIFICATION TO LR 5200 FILM RECORDER is a medical device that received FDA 510(k) clearance on 2001-09-20. The listed applicant is Agfa Corp.. The 510(k) number is K012010.

When did MODIFICATION TO LR 5200 FILM RECORDER receive FDA 510(k) clearance?

MODIFICATION TO LR 5200 FILM RECORDER received FDA 510(k) clearance on 2001-09-20, under 510(k) number K012010.

Who is the listed applicant for MODIFICATION TO LR 5200 FILM RECORDER?

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 MODIFICATION TO LR 5200 FILM RECORDER?

The FDA product code for MODIFICATION TO LR 5200 FILM RECORDER is LMC.

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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: 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

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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