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FDA 510(k)

KONICA DIRECT DIGITIZER REGIUS MODEL 330

K-Number: K980873 · 1998-06-19

ApplicantKonica Corp.
Decision Date1998-06-19
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KONICA DIRECT DIGITIZER REGIUS MODEL 330 is the device name listed in this FDA 510(k) record. The listed applicant is Konica Corp.. It received FDA 510(k) clearance on 1998-06-19 under 510(k) number K980873. 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 KONICA DIRECT DIGITIZER REGIUS MODEL 330?

KONICA DIRECT DIGITIZER REGIUS MODEL 330 is a medical device that received FDA 510(k) clearance on 1998-06-19. The listed applicant is Konica Corp.. The 510(k) number is K980873.

When did KONICA DIRECT DIGITIZER REGIUS MODEL 330 receive FDA 510(k) clearance?

KONICA DIRECT DIGITIZER REGIUS MODEL 330 received FDA 510(k) clearance on 1998-06-19, under 510(k) number K980873.

Who is the listed applicant for KONICA DIRECT DIGITIZER REGIUS MODEL 330?

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

What is the FDA product code for KONICA DIRECT DIGITIZER REGIUS MODEL 330?

The FDA product code for KONICA DIRECT DIGITIZER REGIUS MODEL 330 is LMA.

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Other records listing Konica 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.

K992586KONICA LASER IMAGER, DRYPRO MODEL 722K990359KONICA DIRECT DIGITIZER, MODEL DD-341K920769KONICA LI 10 AND 10A LASER IMAGERK920558KONICA DIRECT DIGITIZER KD-1000

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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