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FDA 510(k)

REALTIME 3D DIAGNOSTIC WORKSTATION

K-Number: K973010 · 1997-11-10

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1997-11-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REALTIME 3D DIAGNOSTIC WORKSTATION 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 1997-11-10 under 510(k) number K973010. 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 REALTIME 3D DIAGNOSTIC WORKSTATION?

REALTIME 3D DIAGNOSTIC WORKSTATION is a medical device that received FDA 510(k) clearance on 1997-11-10. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K973010.

When did REALTIME 3D DIAGNOSTIC WORKSTATION receive FDA 510(k) clearance?

REALTIME 3D DIAGNOSTIC WORKSTATION received FDA 510(k) clearance on 1997-11-10, under 510(k) number K973010.

Who is the listed applicant for REALTIME 3D DIAGNOSTIC WORKSTATION?

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 REALTIME 3D DIAGNOSTIC WORKSTATION?

The FDA product code for REALTIME 3D DIAGNOSTIC WORKSTATION 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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