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FDA 510(k)

EXEL 2400 AND 2400 ELITE CT SCANNERS

K-Number: K884671 · 1989-01-18

ApplicantElscint, Inc.
Decision Date1989-01-18
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXEL 2400 AND 2400 ELITE CT SCANNERS is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1989-01-18 under 510(k) number K884671. 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 2400 AND 2400 ELITE CT SCANNERS?

EXEL 2400 AND 2400 ELITE CT SCANNERS is a medical device that received FDA 510(k) clearance on 1989-01-18. The listed applicant is Elscint, Inc.. The 510(k) number is K884671.

When did EXEL 2400 AND 2400 ELITE CT SCANNERS receive FDA 510(k) clearance?

EXEL 2400 AND 2400 ELITE CT SCANNERS received FDA 510(k) clearance on 1989-01-18, under 510(k) number K884671.

Who is the listed applicant for EXEL 2400 AND 2400 ELITE CT SCANNERS?

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 2400 AND 2400 ELITE CT SCANNERS?

The FDA product code for EXEL 2400 AND 2400 ELITE CT SCANNERS 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

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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