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FDA 510(k)

OPDIMA

K-Number: K003945 · 2001-02-02

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2001-02-02
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPDIMA is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2001-02-02 under 510(k) number K003945. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPDIMA?

OPDIMA is a medical device that received FDA 510(k) clearance on 2001-02-02. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K003945.

When did OPDIMA receive FDA 510(k) clearance?

OPDIMA received FDA 510(k) clearance on 2001-02-02, under 510(k) number K003945.

Who is the listed applicant for OPDIMA?

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

What is the FDA product code for OPDIMA?

The FDA product code for OPDIMA is IZH.

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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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