Cleared Special

K022001 - MPOWER, MODEL 712 SERIES

K022001 is an FDA 510(k) clearance for MPOWER, manufactured by Positron Corp.. The device is a Class 2 Radiology device with product code KPS cleared through the Special 510(k) pathway after a 23-day FDA review.

K022001 · Positron Corp. · Radiology device
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Jul 2002
Decision
23d
Days
Class 2
Risk

K022001 is an FDA 510(k) clearance for the MPOWER, MODEL 712 SERIES. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Positron Corp. (Houston, US). The FDA issued a Cleared decision on July 12, 2002 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K022001

510(k) Number K022001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2002
Decision Date July 12, 2002
Days to Decision 23 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 470
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K022001.
GE ROAD WARRIOR PET CT IMAGING SYSTEM
K022872 · General Electric Co. · Sep 2002
ECAT VISION PET SCANNER, MODELS 3000 & 5000
K021633 · Cti Pet Systems, Inc. · Aug 2002
MOBILE MILLENNIUM MG SYSTEM
K022240 · Ge Medical Systems, Inc. · Aug 2002
CARDIOSPECT D90/CARDIO CAM
K021823 · Nuclear Cardiology Systems, Inc. · Jun 2002
HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4
K021656 · Nuclear Diagnostics · Jun 2002
NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)
K020300 · Syntermed, Inc. · Apr 2002
K022001 · MPOWER, MODEL 712 SERIES
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