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FDA 510(k)

IMAGE STAR II

K-Number: K052610 · 2005-11-30

ApplicantLakeshore Technologies, Inc.
Decision Date2005-11-30
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGE STAR II is the device name listed in this FDA 510(k) record. The listed applicant is Lakeshore Technologies, Inc.. It received FDA 510(k) clearance on 2005-11-30 under 510(k) number K052610. 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 IMAGE STAR II?

IMAGE STAR II is a medical device that received FDA 510(k) clearance on 2005-11-30. The listed applicant is Lakeshore Technologies, Inc.. The 510(k) number is K052610.

When did IMAGE STAR II receive FDA 510(k) clearance?

IMAGE STAR II received FDA 510(k) clearance on 2005-11-30, under 510(k) number K052610.

Who is the listed applicant for IMAGE STAR II?

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

What is the FDA product code for IMAGE STAR II?

The FDA product code for IMAGE STAR II is JAA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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