510(k) Report

510(k) · Cleared

Cleared

Radiocameras Extracranial System

K000246510(k) TraditionalCleared Oct 20, 2000267-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

Surgical Navigation Technologies, Inc. · IYE Accelerator, Linear, Medical

Cleared on Oct 20, 2000 after a 267-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Oct 20, 2000
Review
267 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared2007: 1 descendant cleared2014: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK000246 Radiocameras Extracranial SystemSurgical Navigation Technologies, Inc. · 2000
  2. Descendant · cites it directly · 2 of its ownK071360 Optical Guidance PlatformVarian Medical Systems, Inc. · 2007 · Recalled
  3. Descendant · 2 generations on · 1 of its ownK142560 Varian Head FrameVarian Medical Systems, Inc. · 2014 · Recalled
  4. Descendant · 3 generations on · 0 of its ownK180586 Varian Head FrameVarian Medical Systems, Inc. · 2018
  5. Descendant · cites it directly · 0 of its ownK042875 NavigatorNomos Corp. · 2005

Most influential descendants

Showing 4 of 4 · See all
  • K071360Optical Guidance PlatformVarian Medical Systems, Inc. · 2007 · cites it directly2descendants
  • K142560Varian Head FrameVarian Medical Systems, Inc. · 2014 · 2 generations on1descendant
  • K180586Varian Head FrameVarian Medical Systems, Inc. · 2018 · 3 generations on0descendants
  • K042875NavigatorNomos Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000246Radiocameras Extracranial SystemSurgical Navigation Technologies, Inc.2000—
+1K071360Optical Guidance PlatformVarian Medical Systems, Inc.20075
+2K142560Varian Head FrameVarian Medical Systems, Inc.20141
+3K180586Varian Head FrameVarian Medical Systems, Inc.2018—
+1K042875NavigatorNomos Corp.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
201410
201810
FIG. 1 — Lineage of K000246, 2000–2018Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K071360Optical Guidance PlatformVarian Medical Systems, Inc.20072
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?

  • Of its descendants, K071360 (Varian Medical Systems, Inc., 2007) has gone furthest, with 2 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—

More from Surgical Navigation Technologies, Inc.

27 FDA decisions under this applicant name. See the company

  • K994355Radiocameras System Head/Neck ApplicationSurgical Navigation Technologies, Inc. · 2000
  • K992461Stealthstation Treatment Guidance PlatformSurgical Navigation Technologies, Inc. · 2000
  • K992927Stealthstation Treatment Guidance PlatformSurgical Navigation Technologies, Inc. · 19992 recalls
  • K993021Metrx SystemSurgical Navigation Technologies, Inc. · 19993 recalls
  • K992354SNT Image Analysis SystemSurgical Navigation Technologies, Inc. · 1999

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/K000246 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000246: Radiocameras Extracranial System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000246

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026