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FDA 510(k)

LINEAR SCANNER PROBE ELSCINT LTD. TL-35

K-Number: K844189 · 1985-02-25

ApplicantElscint, Inc.
Decision Date1985-02-25
Product CodeIYP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LINEAR SCANNER PROBE ELSCINT LTD. TL-35 is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1985-02-25 under 510(k) number K844189. The device is classified under product code IYP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINEAR SCANNER PROBE ELSCINT LTD. TL-35?

LINEAR SCANNER PROBE ELSCINT LTD. TL-35 is a medical device that received FDA 510(k) clearance on 1985-02-25. The listed applicant is Elscint, Inc.. The 510(k) number is K844189.

When did LINEAR SCANNER PROBE ELSCINT LTD. TL-35 receive FDA 510(k) clearance?

LINEAR SCANNER PROBE ELSCINT LTD. TL-35 received FDA 510(k) clearance on 1985-02-25, under 510(k) number K844189.

Who is the listed applicant for LINEAR SCANNER PROBE ELSCINT LTD. TL-35?

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 LINEAR SCANNER PROBE ELSCINT LTD. TL-35?

The FDA product code for LINEAR SCANNER PROBE ELSCINT LTD. TL-35 is IYP.

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Related Devices (Code: IYP)

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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