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FDA 510(k)

SIEMENS PACS/I-A

K-Number: K880690 · 1988-10-31

ApplicantSiemens Gammasonics, Inc.
Decision Date1988-10-31
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIEMENS PACS/I-A is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Gammasonics, Inc.. It received FDA 510(k) clearance on 1988-10-31 under 510(k) number K880690. 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 SIEMENS PACS/I-A?

SIEMENS PACS/I-A is a medical device that received FDA 510(k) clearance on 1988-10-31. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K880690.

When did SIEMENS PACS/I-A receive FDA 510(k) clearance?

SIEMENS PACS/I-A received FDA 510(k) clearance on 1988-10-31, under 510(k) number K880690.

Who is the listed applicant for SIEMENS PACS/I-A?

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

What is the FDA product code for SIEMENS PACS/I-A?

The FDA product code for SIEMENS PACS/I-A 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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