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FDA 510(k)

IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM

K-Number: K983567 · 1999-01-07

ApplicantMed Images, Inc.
Decision Date1999-01-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Med Images, Inc.. It received FDA 510(k) clearance on 1999-01-07 under 510(k) number K983567. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM?

IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1999-01-07. The listed applicant is Med Images, Inc.. The 510(k) number is K983567.

When did IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM receive FDA 510(k) clearance?

IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM received FDA 510(k) clearance on 1999-01-07, under 510(k) number K983567.

Who is the listed applicant for IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM?

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

What is the FDA product code for IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM?

The FDA product code for IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM is GCJ.

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Related Devices (Code: GCJ)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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