510(k) Report

510(k) · Cleared

Cleared

Restitu

K041937510(k) TraditionalCleared Nov 16, 2004120-day reviewClass II21 CFR 892.5050

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

Resonant Medical, Inc. · IYE Accelerator, Linear, Medical

Cleared on Nov 16, 2004 as substantially equivalent to K981424 (Nomos Corp., 1998) and 3 other predicates after a 120-day review. Its family tree reaches back 4 generations to 1985. 3 later devices descend from it.

Decided
Nov 16, 2004
Review
120 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K851659 (1985). 13 ancestors in all. 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor1992: 2 other ancestors2001: 2 other ancestors1996: 1 other ancestor1994: 2 other ancestors1993: 1 other ancestor2012: 2 descendants cleared2014: 1 descendant clearedK851659 · Skull Mounted Stereotactic Surgical Device · Medco Products, Co., Inc. · 1985K955397 · Mayfield-Acciss Workstation · Nomos Corp. · 1996K981424 · Nomos Bat Ultrasound Localization and Positioning System · Nomos Corp. · 1998K032100 · I-BEAM · Computerized Medical Systems, Inc. · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K032100 · I-BEAM · Computerized Medical Systems, Inc. · 2003K981424 · Nomos Bat Ultrasound Localization and Positioning System · Nomos Corp. · 1998K955397 · Mayfield-Acciss Workstation · Nomos Corp. · 1996K851659 · Skull Mounted Stereotactic Surgical Device · Medco Products, Co., Inc. · 19850
  1. Root · 4 generations backK851659 Skull Mounted Stereotactic Surgical DeviceMedco Products, Co., Inc. · 1985
  2. 3 generations backK955397 Mayfield-Acciss WorkstationNomos Corp. · 1996
  3. 2 generations backK981424 Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp. · 1998
  4. 1 generation backK032100 I-BEAMComputerized Medical Systems, Inc. · 2003
  5. This deviceK041937 RestituResonant Medical, Inc. · 2004
  6. Descendant · cites it directly · 2 of its ownK111332 Clarity Obp SystemElekta, Ltd. · 2012
  7. Descendant · 2 generations on · 1 of its ownK121663 ClarityElekta, Ltd. · 2012
  8. Descendant · 3 generations on · 0 of its ownK141855 ClarityElekta, Ltd. · 2014

Most influential descendants

Showing 3 of 3 · See all
  • K111332Clarity Obp SystemElekta, Ltd. · 2012 · cites it directly2descendants
  • K121663ClarityElekta, Ltd. · 2012 · 2 generations on1descendant
  • K141855ClarityElekta, Ltd. · 2014 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K851659Skull Mounted Stereotactic Surgical DeviceMedco Products, Co., Inc.1985—
−3K955397Mayfield-Acciss WorkstationNomos Corp.1996—
−2K981424Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp.1998—
−1K032100I-BEAMComputerized Medical Systems, Inc.2003—
0 (this device)K041937RestituResonant Medical, Inc.2004—
+1K111332Clarity Obp SystemElekta, Ltd.2012—
+2K121663ClarityElekta, Ltd.2012—
+3K141855ClarityElekta, Ltd.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199310
199420
199610
200120
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201410
FIG. 1 — Lineage of K041937, 1985–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

Planning a device in IYE? 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 IYE device

  1. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K981424Nomos Bat Ultrasound Localization and Positioning System
Summary page 1
…Common name: Patient Positioning System, Ultrasound Classification: Class HI, 892.5050, 5750, 5780, or 5840 Substantial equivalence claimed to: 1. K981424 - NOMOS Corporation, BAT® Ultrasound Localization and Positioning System 2. K0321…
Nomos Corp.1998—
*K032100I-BEAM
Summary page 1
…tial equivalence claimed to: 1. K981424 - NOMOS Corporation, BAT® Ultrasound Localization and Positioning System 2. K032100 - Computerized Medical Systems, Inc., I-Beam 3. K030981 - Varian Medical Systems, Inc., Eclipse 4. K923851 - Phillips…
Computerized Medical Systems, Inc.2003—
*K030981Eclipse
Summary page 1
…ion, BAT® Ultrasound Localization and Positioning System 2. K032100 - Computerized Medical Systems, Inc., I-Beam 3. K030981 - Varian Medical Systems, Inc., Eclipse 4. K923851 - Phillips Medical Systems, Inc., ACQSIM Simulator/Localizer Descriptio…
Varian Medical Systems, Inc.2003—
*K923851Acqsim Simulator/Localizer
Summary page 1
…Positioning System 2. K032100 - Computerized Medical Systems, Inc., I-Beam 3. K030981 - Varian Medical Systems, Inc., Eclipse 4. K923851 - Phillips Medical Systems, Inc., ACQSIM Simulator/Localizer Description: The RESTITU system integrates medical diagnostic ultr…
Philips Medical Systems (Cleveland), Inc.1992—

Also cleared against K981424: 3 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K111332Clarity Obp SystemElekta, Ltd.20122

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?

  • The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
  • 1 of the 13 ancestors has a recall of any class.
  • Of its descendants, K111332 (Elekta, Ltd., 2012) has gone furthest, with 2 descendants of its own.
  • 3 other devices also cite its predicate K981424.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

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

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
2007high 280 (2011) · low 66 (2022)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

What is it indicated for?

RESTITU™ can be used for the positioning of patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images.

Indications for use as stated in the FDA summary.

Also cleared against K981424

3 other devices cite the same predicate.

  • K042875NavigatorNomos Corp. · 2005
  • K042110BeamcathBeampoint AB · 2005
  • K032100I-BEAMComputerized Medical Systems, Inc. · 2003

Recent decisions in IYE

The IYE category page

  • K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC · 2026
  • K261718EZFluence (RADEZ V2)Radformation, Inc. · 2026
  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K252937ThinkQA 3Dosisoft SA · 2026

https://510kreport.com/device/K041937 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041937: Restitu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041937

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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