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FDA 510(k)

DICOM 3.0 SOFTWARE VERSION 2.0

K-Number: K973239 · 1997-11-26

ApplicantAdac Laboratories
Decision Date1997-11-26
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DICOM 3.0 SOFTWARE VERSION 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Adac Laboratories. It received FDA 510(k) clearance on 1997-11-26 under 510(k) number K973239. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DICOM 3.0 SOFTWARE VERSION 2.0?

DICOM 3.0 SOFTWARE VERSION 2.0 is a medical device that received FDA 510(k) clearance on 1997-11-26. The listed applicant is Adac Laboratories. The 510(k) number is K973239.

When did DICOM 3.0 SOFTWARE VERSION 2.0 receive FDA 510(k) clearance?

DICOM 3.0 SOFTWARE VERSION 2.0 received FDA 510(k) clearance on 1997-11-26, under 510(k) number K973239.

Who is the listed applicant for DICOM 3.0 SOFTWARE VERSION 2.0?

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

What is the FDA product code for DICOM 3.0 SOFTWARE VERSION 2.0?

The FDA product code for DICOM 3.0 SOFTWARE VERSION 2.0 is LMD.

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Other records listing Adac Laboratories 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.

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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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