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FDA 510(k)

XRT-7.0

K-Number: K964583 · 1997-01-17

ApplicantElscint, Inc.
Decision Date1997-01-17
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XRT-7.0 is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1997-01-17 under 510(k) number K964583. 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 XRT-7.0?

XRT-7.0 is a medical device that received FDA 510(k) clearance on 1997-01-17. The listed applicant is Elscint, Inc.. The 510(k) number is K964583.

When did XRT-7.0 receive FDA 510(k) clearance?

XRT-7.0 received FDA 510(k) clearance on 1997-01-17, under 510(k) number K964583.

Who is the listed applicant for XRT-7.0?

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 XRT-7.0?

The FDA product code for XRT-7.0 is JAK.

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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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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