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FDA 510(k)

SURGPLAN AND PANPLAN

K-Number: K041078 · 2004-12-23

ApplicantImaging Sciences Intl., Inc.
Decision Date2004-12-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SURGPLAN AND PANPLAN is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Sciences Intl., Inc.. It received FDA 510(k) clearance on 2004-12-23 under 510(k) number K041078. 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 SURGPLAN AND PANPLAN?

SURGPLAN AND PANPLAN is a medical device that received FDA 510(k) clearance on 2004-12-23. The listed applicant is Imaging Sciences Intl., Inc.. The 510(k) number is K041078.

When did SURGPLAN AND PANPLAN receive FDA 510(k) clearance?

SURGPLAN AND PANPLAN received FDA 510(k) clearance on 2004-12-23, under 510(k) number K041078.

Who is the listed applicant for SURGPLAN AND PANPLAN?

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

What is the FDA product code for SURGPLAN AND PANPLAN?

The FDA product code for SURGPLAN AND PANPLAN is LLZ.

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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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