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FDA 510(k)

EXCEL CT TWIN

K-Number: K915738 · 1992-07-21

ApplicantElscint, Inc.
Decision Date1992-07-21
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXCEL CT TWIN is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1992-07-21 under 510(k) number K915738. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCEL CT TWIN?

EXCEL CT TWIN is a medical device that received FDA 510(k) clearance on 1992-07-21. The listed applicant is Elscint, Inc.. The 510(k) number is K915738.

When did EXCEL CT TWIN receive FDA 510(k) clearance?

EXCEL CT TWIN received FDA 510(k) clearance on 1992-07-21, under 510(k) number K915738.

Who is the listed applicant for EXCEL CT TWIN?

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

What is the FDA product code for EXCEL CT TWIN?

The FDA product code for EXCEL CT TWIN is JAK.

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Other records listing Elscint, 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.

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Related Devices (Code: JAK)

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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