# K022001: Mpower, Model 712 Series

- Pathway: 510(k) (Special)
- Applicant: Positron Corp.
- Decided: Jul 12, 2002 after 23 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K090178: Attrius, Model PET150A6001, Attrius L, Model PET150A8001, Truesight, Model NSP-P6C, Truesight, Model NSP-P8 (2009), 7 descendants of its own
- K143664: HeartSee (2015), 6 descendants of its own
- K171303: Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 (2017), 5 descendants of its own
- K202679: Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 (2021), 2 descendants of its own
- K231731: Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 (2023), 1 descendant of its own

## Indications for use
The Positron Corporation POSICAM HZm, POSICAM HZLm, mPowerTMPET scanners are intended to be used for whole body, multislice, positron emission tomography diagnostic imaging.

Source page: https://510kreport.com/device/K022001
Methodology: https://510kreport.com/methodology