510(k) · Cleared

Cleared

Preference Treatment System

K983793510(k) TraditionalCleared Oct 5, 1999343-day reviewClass II21 CFR 892.1000

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

Northwest Medical Physics Equipment, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Oct 5, 1999 as substantially equivalent to K970464 (Northwest Medical Physics Equipment, Inc., 1997) after a 343-day review. Its family tree reaches back 1 generation to 1997. 13 later devices descend from it.

Decided: Oct 5, 1999
Review: 343 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K970464 (1997). 13 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK970464 P Reference TPS (Treatment Planning Software) 1.1Northwest Medical Physics Equipment, Inc. · 1997
This deviceK983793 Preference Treatment SystemNorthwest Medical Physics Equipment, Inc. · 1999
Descendant · cites it directly · 12 of its ownK012575 Prefernce Imrt Treatment Planning ModuleNorthwest Medical Physics Equipment, Inc. · 2002
Descendant · 2 generations on · 11 of its ownK060906 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2006
Descendant · 3 generations on · 9 of its ownK080726 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008
Descendant · 3 generations on · 6 of its ownK102373 Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010
Descendant · 3 generations on · 4 of its ownK112768 Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2002high 3 (2012) · low 0 (2003)2026

Most influential descendants

Showing 5 of 13 · See all

K012575Prefernce Imrt Treatment Planning ModuleNorthwest Medical Physics Equipment, Inc. · 2002 · cites it directly12descendants
K060906Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2006 · 2 generations on11descendants
K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008 · 3 generations on9descendants
K102373Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010 · 3 generations on6descendants
K112768Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970464	P Reference TPS (Treatment Planning Software) 1.1	Northwest Medical Physics Equipment, Inc.	1997	—
0 (this device)	K983793	Preference Treatment System	Northwest Medical Physics Equipment, Inc.	1999	—
+1	K012575	Prefernce Imrt Treatment Planning Module	Northwest Medical Physics Equipment, Inc.	2002	—
+2	K060906	Calypso 4D Localization System	Calypso Medical Technologies, Inc.	2006	—
+3	K080726	Calypso 4D Localization System	Calypso Medical Technologies, Inc.	2008	—
+3	K102373	Calypso System with Dynamic Edge Gating	Calypso Medical Technologies, Inc.	2010	—
+3	K112768	Calypso Systems with Dynamic Edge Gating	Calypso Medical Technologies, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2006	1	0
2008	1	0
2010	1	0
2011	1	0
2012	3	0
2014	2	0
2015	1	0
2018	1	0
2021	1	0

FIG. 1 — Lineage of K983793, 1997–2021Source: 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 LNH? 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 LNH device

#1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K970464	P Reference TPS (Treatment Planning Software) 1.1 Summary page 2 …n):____ (new product) Device Name: pReference Treatment System Indications For Use: The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcino…	Northwest Medical Physics Equipment, Inc.	1997	—

Also cleared against K970464: 3 other devices →

What descends from it? (13)

See all 13

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012575	Prefernce Imrt Treatment Planning Module	Northwest Medical Physics Equipment, Inc.	2002	12

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?

Its one ancestor has no recall.
Of its descendants, K012575 (Northwest Medical Physics Equipment, Inc., 2002) has gone furthest, with 12 descendants of its own.
3 other devices also cite its predicate K970464.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007high 140 (2015) · low 35 (2007)2026

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

Recalls per year · LNH

8in 2025

2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, 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	12	35	25	114
2008	19	53	12	167
2009	17	70	7	194
2010	12	94	17	165
2011	16	81	11	182
2012	22	89	5	170
2013	19	108	2	107
2014	17	108	13	119
2015	19	140	12 (2)	113
2016	20	108	1	135
2017	18	98	0	121
2018	29	128	71	158
2019	26	62	5	158
2020	32	121	4	98
2021	27	87	41	84
2022	30	74	13	138
2023	30	124	10 (1)	159
2024	26	104	4	281
2025	26	122	8 (5)	1,263
2026	24	126	43	—

What is it indicated for?

The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas. The indications for use of pReference Treatment System are expanded to include lesions requiring extracranial stereotactic radiotherapy or radiosurgery. These include hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and…

Read the full statement (101 words)

The indications for use of pReference Treatment System are expanded to include lesions requiring extracranial stereotactic radiotherapy or radiosurgery. These include hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.

The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the the target with respect to implanted fiducials, to define and visualize treatment beam locatlons, and to visualize dose to the target and other structures.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K983793 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983793: Preference Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983793

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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