FDA 510(k)

MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM

K-Number: K913630 · 1991-10-23

Decision Date1991-10-23

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM 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 1991-10-23 under 510(k) number K913630. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM?

MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM is a medical device that received FDA 510(k) clearance on 1991-10-23. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K913630.

When did MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM receive FDA 510(k) clearance?

MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM received FDA 510(k) clearance on 1991-10-23, under 510(k) number K913630.

Who is the listed applicant for MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM?

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 MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM?

The FDA product code for MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM is KPS.

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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.