FDA 510(k)

MODIFICATION TO: VIEWSTATION

K-Number: K043412 · 2004-12-20

Decision Date2004-12-20

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: VIEWSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Impac Medical Systems, Inc.. It received FDA 510(k) clearance on 2004-12-20 under 510(k) number K043412. 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 MODIFICATION TO: VIEWSTATION?

MODIFICATION TO: VIEWSTATION is a medical device that received FDA 510(k) clearance on 2004-12-20. The listed applicant is Impac Medical Systems, Inc.. The 510(k) number is K043412.

When did MODIFICATION TO: VIEWSTATION receive FDA 510(k) clearance?

MODIFICATION TO: VIEWSTATION received FDA 510(k) clearance on 2004-12-20, under 510(k) number K043412.

Who is the listed applicant for MODIFICATION TO: VIEWSTATION?

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

What is the FDA product code for MODIFICATION TO: VIEWSTATION?

The FDA product code for MODIFICATION TO: VIEWSTATION 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.