510(k) Report

510(k) · Cleared

Cleared

Nomos Bat Ultrasound Localization and Positioning System

K981424510(k) TraditionalCleared Jul 17, 199888-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

Nomos Corp. · IYE Accelerator, Linear, Medical

Cleared on Jul 17, 1998 as substantially equivalent to K945957 (Kleinfeld, Kaplan and Becker, 1996) and 3 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1985. 10 later devices descend from it.

Decided
Jul 17, 1998
Review
88 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K851659 (1985). 7 ancestors in all. 10 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1994: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor2005: 2 descendants cleared2003: 1 descendant cleared2004: 1 descendant cleared2012: 2 descendants cleared2008: 1 descendant cleared2013: 1 descendant cleared2014: 2 descendants clearedReference device: K802146 · Aquasonic 100 Ultrasound Trans. Gel, · Parker Laboratories, Inc. · 1980 · recalledK851659 · Skull Mounted Stereotactic Surgical Device · Medco Products, Co., Inc. · 1985K955397 · Mayfield-Acciss Workstation · Nomos Corp. · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K955397 · Mayfield-Acciss Workstation · Nomos Corp. · 1996K851659 · Skull Mounted Stereotactic Surgical Device · Medco Products, Co., Inc. · 19850
  1. Root · 2 generations backK851659 Skull Mounted Stereotactic Surgical DeviceMedco Products, Co., Inc. · 1985
  2. 1 generation backK955397 Mayfield-Acciss WorkstationNomos Corp. · 1996
  3. This deviceK981424 Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp. · 1998
  4. Descendant · cites it directly · 4 of its ownK032100 I-BEAMComputerized Medical Systems, Inc. · 2003
  5. Descendant · cites it directly · 3 of its ownK042110 BeamcathBeampoint AB · 2005
  6. Descendant · cites it directly · 3 of its ownK041937 RestituResonant Medical, Inc. · 2004
  7. Descendant · 2 generations on · 2 of its ownK111332 Clarity Obp SystemElekta, Ltd. · 2012
  8. Descendant · 2 generations on · 1 of its ownK131655 Lighthouse (TM) Urinary CatheterSeedings Life Science Ventures, LLC · 2013

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 22008: 12012: 22013: 12014: 2
2003high 2 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 10 · See all
  • K032100I-BEAMComputerized Medical Systems, Inc. · 2003 · cites it directly4descendants
  • K042110BeamcathBeampoint AB · 2005 · cites it directly3descendants
  • K041937RestituResonant Medical, Inc. · 2004 · cites it directly3descendants
  • K111332Clarity Obp SystemElekta, Ltd. · 2012 · 2 generations on2descendants
  • K131655Lighthouse (TM) Urinary CatheterSeedings Life Science Ventures, LLC · 2013 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K851659Skull Mounted Stereotactic Surgical DeviceMedco Products, Co., Inc.1985—
−1K955397Mayfield-Acciss WorkstationNomos Corp.1996—
0 (this device)K981424Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp.1998—
+1K032100I-BEAMComputerized Medical Systems, Inc.2003—
+1K042110BeamcathBeampoint AB2005—
+1K041937RestituResonant Medical, Inc.2004—
+2K111332Clarity Obp SystemElekta, Ltd.2012—
+2K131655Lighthouse (TM) Urinary CatheterSeedings Life Science Ventures, LLC2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
199420
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200520
200810
201220
201310
201420
FIG. 1 — Lineage of K981424, 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
*K945957Ausonics Opus 2 Realtime Ultrasound Scanner
Summary page 1
…ning System Applicant Name and Address NOMOS Corporation 2591 Wexford Bayne Road Sewickley. PA 15143 2. Names of Predicate Devices' Product Clearance Number Ausonics K945957 OPUS 2 Realtime Ultrasound Scanner MMS TherpacPLUS 6.6 B3SDTUI K930506 (K930506) Treatment Planning System CP Bio-Medical Corp…
Kleinfeld, Kaplan and Becker1996—
*K930506Therpac Radiotherapy Treatment Planning System
Summary page 1
…yne Road Sewickley. PA 15143 2. Names of Predicate Devices' Product Clearance Number Ausonics K945957 OPUS 2 Realtime Ultrasound Scanner MMS TherpacPLUS 6.6 B3SDTUI K930506 (K930506) Treatment Planning System CP Bio-Medical Corp. K930295 PatPos Compact Laser Positioning Device Mayfield/ACCISS Stereo…
Pinecliff Assoc.1994—
*K930295Patpos Compact
Summary page 1
…duct Clearance Number Ausonics K945957 OPUS 2 Realtime Ultrasound Scanner MMS TherpacPLUS 6.6 B3SDTUI K930506 (K930506) Treatment Planning System CP Bio-Medical Corp. K930295 PatPos Compact Laser Positioning Device Mayfield/ACCISS Stereotactic Workstation K955397 3. Classification Clearance Date 4/1…
Cp Bio-Medical Corp.1993—
*K955397Mayfield-Acciss Workstation
Summary page 1
…S 6.6 B3SDTUI K930506 (K930506) Treatment Planning System CP Bio-Medical Corp. K930295 PatPos Compact Laser Positioning Device Mayfield/ACCISS Stereotactic Workstation K955397 3. Classification Clearance Date 4/15/96 8/29/94 5/21/93 4/30/96 This device is classified as a class Il device according…
Nomos Corp.1996—
†K802146Aquasonic 100 Ultrasound Trans. Gel,Parker Laboratories, Inc.19801

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K032100I-BEAMComputerized Medical Systems, Inc.20034
K042110BeamcathBeampoint AB20053
K041937RestituResonant Medical, Inc.20043
K042875NavigatorNomos Corp.20050

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 13 years and passes through 2 companies; a new generation was cleared every 10.8 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K032100 (Computerized Medical Systems, Inc., 2003) has gone furthest, with 4 descendants of its own.

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?

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

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Nomos Corp.

21 FDA decisions under this applicant name. See the company

  • K070611Bat Ultrasound Localization and Positioning System, Version 6Nomos Corp. · 2007
  • K060895Nomosstat, Version 1.0Nomos Corp. · 2006
  • K042875NavigatorNomos Corp. · 2005
  • K032209Nomos Corvus 5.0MNomos Corp. · 2003
  • K013036Nomos Motorized Crane IINomos Corp. · 2001

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/K981424 · printed Nov 5, 2026

Cite this page

510(k) Report. “K981424: Nomos Bat Ultrasound Localization and Positioning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981424

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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