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FDA 510(k)

PRISM VIEW, MODEL

K-Number: K063031 · 2006-11-02

ApplicantKyron Clinical Imaging, Inc.
Decision Date2006-11-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRISM VIEW, MODEL is the device name listed in this FDA 510(k) record. The listed applicant is Kyron Clinical Imaging, Inc.. It received FDA 510(k) clearance on 2006-11-02 under 510(k) number K063031. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISM VIEW, MODEL?

PRISM VIEW, MODEL is a medical device that received FDA 510(k) clearance on 2006-11-02. The listed applicant is Kyron Clinical Imaging, Inc.. The 510(k) number is K063031.

When did PRISM VIEW, MODEL receive FDA 510(k) clearance?

PRISM VIEW, MODEL received FDA 510(k) clearance on 2006-11-02, under 510(k) number K063031.

Who is the listed applicant for PRISM VIEW, MODEL?

The FDA 510(k) record lists Kyron Clinical Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRISM VIEW, MODEL?

The FDA product code for PRISM VIEW, MODEL is LLZ.

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Other records listing Kyron Clinical Imaging, 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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