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FDA 510(k)

LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER

K-Number: K980809 · 1998-05-11

ApplicantLumisys, Inc.
Decision Date1998-05-11
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER is the device name listed in this FDA 510(k) record. The listed applicant is Lumisys, Inc.. It received FDA 510(k) clearance on 1998-05-11 under 510(k) number K980809. The device is classified under product code LMA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER?

LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER is a medical device that received FDA 510(k) clearance on 1998-05-11. The listed applicant is Lumisys, Inc.. The 510(k) number is K980809.

When did LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER receive FDA 510(k) clearance?

LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER received FDA 510(k) clearance on 1998-05-11, under 510(k) number K980809.

Who is the listed applicant for LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER?

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

What is the FDA product code for LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER?

The FDA product code for LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER is LMA.

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Other records listing Lumisys, 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.

K980213DI-2000K953371LUMISYS DICOM TOOKLITK953964LUMISYS, LUMISCAN 20K933129LUMISCAN 50K902347COMPACT LASER IMAGER, MODEL CLI-100K901423DIGITAL IMAGE SCANNER, MODEL DIS-1000

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Related Devices (Code: LMA)

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.

K132183DICOM VIDEOBar Code Computer, Ltd.K130636TELERADPRO EDGE; TELERADPRO EDGE HD-CCDVidar Systems Corp.K130406DIAGNOSTICPRO EDGEVidar Systems Corp.K102476TELERADPROVidar Systems Corp.K093809VIDAR DENTAL FILM DIGITIZERVidar Systems Corp.K091288MEDI-6000 MEDICAL IMAGE DIGITIZERMicrotek International, 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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