510(k) K041840

MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM by Medx, Inc. — Product Code KPS

K041840 is an FDA 510(k) premarket notification submitted by Medx, Inc. for the device "MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM". The FDA issued a decision of Substantially Equivalent on August 20, 2004. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Medx, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2004
Date Received
July 8, 2004
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