510(k) K922372

MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM by Siemens Gammasonics, Inc. — Product Code KPS

K922372 is an FDA 510(k) premarket notification submitted by Siemens Gammasonics, Inc. for the device "MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM". The FDA issued a decision of Substantially Equivalent on August 17, 1992. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Siemens Gammasonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1992
Date Received
May 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type