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FDA 510(k)

FULL FRAME ZOOM SYSTEM

K-Number: K961193 · 1996-06-17

ApplicantXre Corp.
Decision Date1996-06-17
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FULL FRAME ZOOM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Xre Corp.. It received FDA 510(k) clearance on 1996-06-17 under 510(k) number K961193. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FULL FRAME ZOOM SYSTEM?

FULL FRAME ZOOM SYSTEM is a medical device that received FDA 510(k) clearance on 1996-06-17. The listed applicant is Xre Corp.. The 510(k) number is K961193.

When did FULL FRAME ZOOM SYSTEM receive FDA 510(k) clearance?

FULL FRAME ZOOM SYSTEM received FDA 510(k) clearance on 1996-06-17, under 510(k) number K961193.

Who is the listed applicant for FULL FRAME ZOOM SYSTEM?

The FDA 510(k) record lists Xre Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FULL FRAME ZOOM SYSTEM?

The FDA product code for FULL FRAME ZOOM SYSTEM is JAA.

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Other records listing Xre Corp. 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.

K973744UNICATH SP BI-PLANE (MODEL M269 & M289)K960998XRE COLLIMATORK945449UNICATH LLU ANGIOGRAPHIC SYSTEMK936002CINEMAC QASK933460DVFX, MODEL M256K924828BI-N

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Related Devices (Code: JAA)

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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