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FDA 510(k)

ELSCINT'S EXEL 2400E CT SCANNER

K-Number: K894542 · 1989-09-07

ApplicantElscint, Inc.
Decision Date1989-09-07
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ELSCINT'S EXEL 2400E CT SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1989-09-07 under 510(k) number K894542. 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 ELSCINT'S EXEL 2400E CT SCANNER?

ELSCINT'S EXEL 2400E CT SCANNER is a medical device that received FDA 510(k) clearance on 1989-09-07. The listed applicant is Elscint, Inc.. The 510(k) number is K894542.

When did ELSCINT'S EXEL 2400E CT SCANNER receive FDA 510(k) clearance?

ELSCINT'S EXEL 2400E CT SCANNER received FDA 510(k) clearance on 1989-09-07, under 510(k) number K894542.

Who is the listed applicant for ELSCINT'S EXEL 2400E CT SCANNER?

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 ELSCINT'S EXEL 2400E CT SCANNER?

The FDA product code for ELSCINT'S EXEL 2400E CT SCANNER is JAK.

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Other records listing Elscint, Inc. as applicant

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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

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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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