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FDA 510(k)

POLYTRON DIGITAL IMAGING SYSTEM

K-Number: K920705 · 1992-04-27

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1992-04-27
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

POLYTRON DIGITAL IMAGING SYSTEM 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 1992-04-27 under 510(k) number K920705. 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 POLYTRON DIGITAL IMAGING SYSTEM?

POLYTRON DIGITAL IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1992-04-27. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K920705.

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

POLYTRON DIGITAL IMAGING SYSTEM received FDA 510(k) clearance on 1992-04-27, under 510(k) number K920705.

Who is the listed applicant for POLYTRON DIGITAL IMAGING SYSTEM?

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 POLYTRON DIGITAL IMAGING SYSTEM?

The FDA product code for POLYTRON DIGITAL IMAGING SYSTEM 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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