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FDA 510(k)

DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)

K-Number: K973411 · 1997-12-04

ApplicantGeneral Scanning, Inc.
Decision Date1997-12-04
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) is the device name listed in this FDA 510(k) record. The listed applicant is General Scanning, Inc.. It received FDA 510(k) clearance on 1997-12-04 under 510(k) number K973411. 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 DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)?

DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) is a medical device that received FDA 510(k) clearance on 1997-12-04. The listed applicant is General Scanning, Inc.. The 510(k) number is K973411.

When did DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) receive FDA 510(k) clearance?

DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) received FDA 510(k) clearance on 1997-12-04, under 510(k) number K973411.

Who is the listed applicant for DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)?

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

What is the FDA product code for DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)?

The FDA product code for DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) is LMA.

Related Clinical Trials

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.

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Other records listing General Scanning, 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.

K980565LD2000 SERIESK923536NUCLEAR MEDICINE LASER IMAGER

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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