510(k) Report

510(k) · Cleared

Cleared

The Nomos Talon Positioning and Immobilization System

K963860510(k) TraditionalCleared Dec 23, 199688-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 Dec 23, 1996 as substantially equivalent to K912630 (Rsa, Inc., 1991) and 3 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1990.

Decided
Dec 23, 1996
Review
88 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K901670 (1990). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 2 other ancestors1991: 1 other ancestorK901670 · Gnomos Stereotactic Device · Medical Equipment Development Co., Inc. · 199019901992199419961998
Other ancestors, by generation 1 generation back: 3 other ancestors K901670 · Gnomos Stereotactic Device · Medical Equipment Development Co., Inc. · 19900
  1. Root · 1 generation backK901670 Gnomos Stereotactic DeviceMedical Equipment Development Co., Inc. · 1990
  2. This deviceK963860 The Nomos Talon Positioning and Immobilization SystemNomos Corp. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K901670Gnomos Stereotactic DeviceMedical Equipment Development Co., Inc.1990—
0 (this device)K963860The Nomos Talon Positioning and Immobilization SystemNomos Corp.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199320
FIG. 1 — Lineage of K963860, 1990–1996Source: 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? (5)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK811452FDA’s K811452 is Brown-Roberts-Wells Stereotaxic Sytem
Our OCR of the scanned summary read K811452, FDA’s number for Brown-Roberts-Wells Stereotaxic Sytem (Trent Wells, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “RSA XKnife Radiosurgical System/BRW Stereotactic System”. Kept off the family tree.
Summary page 1
…) 2591 Wexford Bayne Road (Suite 400) Sewickley, PA 15143 Ii. Name of predicate device(s): TALON Skull Mount: RSA XKnife Radiosurgical System/BRW Stereotactic System (K811452, K912630 and K923522) NOMOS ReFixTM System (K930279B) gNomos Stereotactic System for neurosurgery (K901670B) Targeting Box: CT…
Trent Wells, Inc.1981—
*K912630Xknife Radiosurgery System
Summary page 1
…exford Bayne Road (Suite 400) Sewickley, PA 15143 Ii. Name of predicate device(s): TALON Skull Mount: RSA XKnife Radiosurgical System/BRW Stereotactic System (K811452, K912630 and K923522) NOMOS ReFixTM System (K930279B) gNomos Stereotactic System for neurosurgery (K901670B) Targeting Box: CT & MR fra…
Rsa, Inc.1991—
*K923522Linac-Based Sterotactic Radiosurgery
Summary page 1
…Road (Suite 400) Sewickley, PA 15143 Ii. Name of predicate device(s): TALON Skull Mount: RSA XKnife Radiosurgical System/BRW Stereotactic System (K811452, K912630 and K923522) NOMOS ReFixTM System (K930279B) gNomos Stereotactic System for neurosurgery (K901670B) Targeting Box: CT & MR frame from BRW…
Radionics Software Applications, Inc.1993—
*K930279Refix (TM) System
Summary page 1
…15143 Ii. Name of predicate device(s): TALON Skull Mount: RSA XKnife Radiosurgical System/BRW Stereotactic System (K811452, K912630 and K923522) NOMOS ReFixTM System (K930279B) gNomos Stereotactic System for neurosurgery (K901670B) Targeting Box: CT & MR frame from BRW Stereotactic System (K811452) CT…
Nomos Corp.1993—
*K901670Gnomos Stereotactic Device
Summary page 1
…t: RSA XKnife Radiosurgical System/BRW Stereotactic System (K811452, K912630 and K923522) NOMOS ReFixTM System (K930279B) gNomos Stereotactic System for neurosurgery (K901670B) Targeting Box: CT & MR frame from BRW Stereotactic System (K811452) CT Reference Pointer: Vertical post of gNomos Stereotacti…
Medical Equipment Development Co., Inc.1990—

Also cleared against K912630: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 4 ancestors has a recall.
  • 4 other devices also cite its predicate K912630.

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?

The NOMOS TALON Positioning and immobilization System is intended to provide an invasive means to repeatedly position and immobilize a patient during:

a) diagnostic procedures in preparation for radiation therapy (RT) treatments of the head or head and neck, and

b) during treatment procedures in the radiation therapy suite.

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

Also cleared against K912630

4 other devices cite the same predicate.

  • K100096Linac Collimator Assembly Housing (Lcah) Model LcahartIntegra Radionics, Inc. · 2010
  • K072454Integra Radionics Interfix Patient AdaptersIntegra Radionics, Inc. · 20071 recall
  • K043409AccuchangerDirex Systems Corp. · 2005
  • K961484Cass System (Modification)Medical Instrumentation & Diagnostics Corp.(Midco) · 1996

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/K963860 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963860: The Nomos Talon Positioning and Immobilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963860

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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