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FDA 510(k)

DI-2000

K-Number: K980213 · 1998-03-17

ApplicantLumisys, Inc.
Decision Date1998-03-17
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DI-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Lumisys, Inc.. It received FDA 510(k) clearance on 1998-03-17 under 510(k) number K980213. 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 DI-2000?

DI-2000 is a medical device that received FDA 510(k) clearance on 1998-03-17. The listed applicant is Lumisys, Inc.. The 510(k) number is K980213.

When did DI-2000 receive FDA 510(k) clearance?

DI-2000 received FDA 510(k) clearance on 1998-03-17, under 510(k) number K980213.

Who is the listed applicant for DI-2000?

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 DI-2000?

The FDA product code for DI-2000 is LMA.

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.

K980809LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASERK953371LUMISYS DICOM TOOKLITK953964LUMISYS, LUMISCAN 20K933129LUMISCAN 50K902347COMPACT LASER IMAGER, MODEL CLI-100K901423DIGITAL IMAGE SCANNER, MODEL DIS-1000

View all 7 devices →

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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