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FDA 510(k)

SIEMENS PACS/1-B (OPTICAL DISK OPTION)

K-Number: K884995 · 1989-02-28

ApplicantSiemens Gammasonics, Inc.
Decision Date1989-02-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIEMENS PACS/1-B (OPTICAL DISK OPTION) 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 1989-02-28 under 510(k) number K884995. 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 SIEMENS PACS/1-B (OPTICAL DISK OPTION)?

SIEMENS PACS/1-B (OPTICAL DISK OPTION) is a medical device that received FDA 510(k) clearance on 1989-02-28. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K884995.

When did SIEMENS PACS/1-B (OPTICAL DISK OPTION) receive FDA 510(k) clearance?

SIEMENS PACS/1-B (OPTICAL DISK OPTION) received FDA 510(k) clearance on 1989-02-28, under 510(k) number K884995.

Who is the listed applicant for SIEMENS PACS/1-B (OPTICAL DISK OPTION)?

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/1-B (OPTICAL DISK OPTION)?

The FDA product code for SIEMENS PACS/1-B (OPTICAL DISK OPTION) is LLZ.

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Other records listing Siemens Gammasonics, Inc. as applicant

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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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