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FDA 510(k)

EXEL 1002 CT SCANNER

K-Number: K884668 · 1988-12-30

ApplicantElscint, Inc.
Decision Date1988-12-30
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXEL 1002 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 1988-12-30 under 510(k) number K884668. 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 EXEL 1002 CT SCANNER?

EXEL 1002 CT SCANNER is a medical device that received FDA 510(k) clearance on 1988-12-30. The listed applicant is Elscint, Inc.. The 510(k) number is K884668.

When did EXEL 1002 CT SCANNER receive FDA 510(k) clearance?

EXEL 1002 CT SCANNER received FDA 510(k) clearance on 1988-12-30, under 510(k) number K884668.

Who is the listed applicant for EXEL 1002 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 EXEL 1002 CT SCANNER?

The FDA product code for EXEL 1002 CT SCANNER 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.

K983313ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORYK982060VOLUMAX CT IMAGING SYSTEMK974344CT SCOPEK980306GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EPK974614GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102K9725922T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)

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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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