510(k) · Cleared

Cleared

Mpower, Model 712 Series

K022001510(k) SpecialCleared Jul 12, 200223-day reviewClass II21 CFR 892.1200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Positron Corp. · KPS System, Tomography, Computed, Emission

Cleared on Jul 12, 2002 after a 23-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.

Decided: Jul 12, 2002
Review: 23 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 0

9 later devices descend from it, 2 citing it directly.

This deviceK022001 Mpower, Model 712 SeriesPositron Corp. · 2002
Descendant · cites it directly · 7 of its ownK090178 Attrius, Model PET150A6001, Attrius L, Model PET150A8001, Truesight…Neusoft Positron Medical Systems Co., Ltd. · 2009
Descendant · 2 generations on · 6 of its ownK143664 HeartSeeUniversity of Texas Medical School AT Houston · 2015
Descendant · 3 generations on · 5 of its ownK171303 Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T…University of Texas Medical School AT Houston, Texas · 2017
Descendant · 4 generations on · 2 of its ownK202679 Optional Screen Display for HeartSee Cardiac P.E.T. Processing…Mcgovern Medical School · 2021
Descendant · 5 generations on · 1 of its ownK231731 Optional Screen Displays for HeartSee Cardiac P.E.T. Processing…Mcgovern Medical School · 2023

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2006high 1 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 9 · See all

K090178Attrius, Model PET150A6001, Attrius L, Model PET150A8001, Truesight, Model NSP-P6C…Neusoft Positron Medical Systems Co., Ltd. · 2009 · cites it directly7descendants
K143664HeartSeeUniversity of Texas Medical School AT Houston · 2015 · 2 generations on6descendants
K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas · 2017 · 3 generations on5descendants
K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School · 2021 · 4 generations on2descendants
K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School · 2023 · 5 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K022001	Mpower, Model 712 Series	Positron Corp.	2002	—
+1	K090178	Attrius, Model PET150A6001, Attrius L, Model PET150A8001, Truesight, Model…	Neusoft Positron Medical Systems Co., Ltd.	2009	—
+2	K143664	HeartSee	University of Texas Medical School AT Houston	2015	—
+3	K171303	Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing…	University of Texas Medical School AT Houston, Texas	2017	—
+4	K202679	Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software -…	Mcgovern Medical School	2021	—
+5	K231731	Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software -…	Mcgovern Medical School	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2009	1	0
2015	1	0
2017	1	0
2018	1	0
2020	1	0
2021	1	0
2023	1	0
2025	1	0

FIG. 1 — Lineage of K022001, 2002–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KPS device

#1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K090178	Attrius, Model PET150A6001, Attrius L, Model PET150A8001, Truesight, Model NSP-P6C…	Neusoft Positron Medical Systems Co., Ltd.	2009	7
K061587	Fullcard Analysis	GE Healthcare	2006	1

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K090178 (Neusoft Positron Medical Systems Co., Ltd., 2009) has gone furthest, with 7 descendants of its own.

How does its category compare?

All KPS devices

KPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPS

12in 2025

2007high 17 (2008) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPS

65in 2025

2007high 112 (2015) · low 25 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KPS

16in 2025

2007high 34 (2011) · low 4 (2010)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · KPS

36in 2025

2007high 240 (2013) · low 10 (2016)2025

MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	38	22	38
2008	17	25	16	11
2009	9	42	14	15
2010	3	91	4	44
2011	7	28	34	56
2012	6	94	13	34
2013	11	84	13	240
2014	11	92	18	33
2015	3	112	5	24
2016	11	65	16	10
2017	11	104	11	31
2018	13	59	12 (3)	26
2019	3	60	5 (5)	105
2020	12	72	8	22
2021	15	66	4	10
2022	5	60	8 (6)	15
2023	12	63	6 (3)	22
2024	11	59	15	23
2025	12	65	16	36
2026	6	67	6	—

What is it indicated for?

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

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K022001 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022001: Mpower, Model 712 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022001

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026