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FDA 510(k)

DIGITAL IMAGING SYSTEM (BSR)

K-Number: K991922 · 1999-09-01

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1999-09-01
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL IMAGING SYSTEM (BSR) 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 1999-09-01 under 510(k) number K991922. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL IMAGING SYSTEM (BSR)?

DIGITAL IMAGING SYSTEM (BSR) is a medical device that received FDA 510(k) clearance on 1999-09-01. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K991922.

When did DIGITAL IMAGING SYSTEM (BSR) receive FDA 510(k) clearance?

DIGITAL IMAGING SYSTEM (BSR) received FDA 510(k) clearance on 1999-09-01, under 510(k) number K991922.

Who is the listed applicant for DIGITAL IMAGING SYSTEM (BSR)?

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 DIGITAL IMAGING SYSTEM (BSR)?

The FDA product code for DIGITAL IMAGING SYSTEM (BSR) is IZI.

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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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