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FDA 510(k)

LR 5200 LASER FILM RECORDER

K-Number: K964414 · 1997-01-27

ApplicantBayer Corp., Agfa Div.
Decision Date1997-01-27
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LR 5200 LASER FILM RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp., Agfa Div.. It received FDA 510(k) clearance on 1997-01-27 under 510(k) number K964414. 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 LR 5200 LASER FILM RECORDER?

LR 5200 LASER FILM RECORDER is a medical device that received FDA 510(k) clearance on 1997-01-27. The listed applicant is Bayer Corp., Agfa Div.. The 510(k) number is K964414.

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

LR 5200 LASER FILM RECORDER received FDA 510(k) clearance on 1997-01-27, under 510(k) number K964414.

Who is the listed applicant for LR 5200 LASER FILM RECORDER?

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

What is the FDA product code for LR 5200 LASER FILM RECORDER?

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

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Other records listing Bayer Corp., Agfa Div. 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.

K981280CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMSK974597ADC COMPACT (AGFA DIAGNOSTIC CENTER)

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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