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FDA 510(k)

FUJI MEDICAL LASER IMAGER FL-IM D

K-Number: K945475 · 1995-03-09

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date1995-03-09
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJI MEDICAL LASER IMAGER FL-IM D is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 1995-03-09 under 510(k) number K945475. 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 FUJI MEDICAL LASER IMAGER FL-IM D?

FUJI MEDICAL LASER IMAGER FL-IM D is a medical device that received FDA 510(k) clearance on 1995-03-09. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K945475.

When did FUJI MEDICAL LASER IMAGER FL-IM D receive FDA 510(k) clearance?

FUJI MEDICAL LASER IMAGER FL-IM D received FDA 510(k) clearance on 1995-03-09, under 510(k) number K945475.

Who is the listed applicant for FUJI MEDICAL LASER IMAGER FL-IM D?

The FDA 510(k) record lists Fujifilm Medical System U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJI MEDICAL LASER IMAGER FL-IM D?

The FDA product code for FUJI MEDICAL LASER IMAGER FL-IM D is LMC.

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Other records listing Fujifilm Medical System U.S.A., Inc. as applicant

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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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