510(k) Report

510(k) · Cleared

Recalled · 2011

Optical Guidance Platform

K071360510(k) SpecialCleared Jun 8, 200724-day reviewClass II21 CFR 892.5050Recalls 5

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

Varian Medical Systems, Inc. · IYE Accelerator, Linear, Medical

Cleared on Jun 8, 2007 as substantially equivalent to K971675 (Surgical Navigation Technologies, Inc., 1997) and 5 other predicates after a 24-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it. It has been recalled 5 times.

Decided
Jun 8, 2007
Review
24 days
Class
Class II
Product code
IYE
Recalls
5
Predicates
6

Its longest line of descent runs back 1 generation to K971675 (1997). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1998: 2 other ancestors1997: 1 other ancestor2014: 1 descendant cleared2018: 1 descendant clearedK971675 · SNT Stereotactic Localization System · Surgical Navigation Technologies, Inc. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K971675 · SNT Stereotactic Localization System · Surgical Navigation Technologies, Inc. · 19970
  1. Root · 1 generation backK971675 SNT Stereotactic Localization SystemSurgical Navigation Technologies, Inc. · 1997
  2. This deviceK071360 Optical Guidance PlatformVarian Medical Systems, Inc. · 2007
  3. Descendant · cites it directly · 1 of its ownK142560 Varian Head FrameVarian Medical Systems, Inc. · 2014 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK180586 Varian Head FrameVarian Medical Systems, Inc. · 2018

Most influential descendants

Showing 2 of 2 · See all
  • K142560Varian Head FrameVarian Medical Systems, Inc. · 2014 · cites it directly1descendant
  • K180586Varian Head FrameVarian Medical Systems, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971675SNT Stereotactic Localization SystemSurgical Navigation Technologies, Inc.1997—
0 (this device)K071360Optical Guidance PlatformVarian Medical Systems, Inc.2007—
+1K142560Varian Head FrameVarian Medical Systems, Inc.20141
+2K180586Varian Head FrameVarian Medical Systems, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199820
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201810
FIG. 1 — Lineage of K071360, 1997–2018Source: 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), 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? (6)

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
*K971675SNT Stereotactic Localization System
Summary page 1
…21 CFR 892.5050, 90 WYE, Class J[. Common/Usual Name: Optical Guidance Platform Predicate Devices: SNT Stereotactic Localization System, K971675 SNT Linac Accessories, K971893 Patient Positioning System, K980750…
Surgical Navigation Technologies, Inc.1997—
*K971893SNT Linac Accessories
Summary page 1
…J[. Common/Usual Name: Optical Guidance Platform Predicate Devices: SNT Stereotactic Localization System, K971675 SNT Linac Accessories, K971893 Patient Positioning System, K980750 Biteblock Localization and Positioning System,…
Surgical Navigation Technologies, Inc.1997—
*K980750Radiocameras Patient Positioning System
Summary page 1
…icate Devices: SNT Stereotactic Localization System, K971675 SNT Linac Accessories, K971893 Patient Positioning System, K980750 Biteblock Localization and Positioning System, K981346 Head/Neck Application, K9943…
Surgical Navigation Technologies, Inc.1998—
*K981346Radiocameras Biteblock Localization and Positioning System
Summary page 1
…SNT Linac Accessories, K971893 Patient Positioning System, K980750 Biteblock Localization and Positioning System, K981346 Head/Neck Application, K994355 RadioCameras Extracranial System, K000246 Device De…
Surgical Navigation Technologies, Inc.1998—
*K994355Radiocameras System Head/Neck Application
Summary page 1
…Patient Positioning System, K980750 Biteblock Localization and Positioning System, K981346 Head/Neck Application, K994355 RadioCameras Extracranial System, K000246 Device Description: The Optical Guidance Platform provides a…
Surgical Navigation Technologies, Inc.2000—
*K000246Radiocameras Extracranial System
Summary page 1
…Biteblock Localization and Positioning System, K981346 Head/Neck Application, K994355 RadioCameras Extracranial System, K000246 Device Description: The Optical Guidance Platform provides a method of positioning the patient for eit…
Surgical Navigation Technologies, Inc.2000—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K142560Varian Head FrameVarian Medical Systems, Inc.20141

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 4, 2011Not classifiedZ-0332-2012Device DesignAn anomaly has been identified with the Head Ring posts used by both the Optical Guidance Platform FrameArray module and the Floorstand where the head ring posts may be damaged due to excessive mechanical stress resulting in possible…
Mar 30, 2011Not classifiedZ-2200-2011Software designA software anomaly has been identified with the Optical Guidance Platform (OGP) Software v2.6 and v2.6.1 where the transfer of datasets from treatment planning systems other than the FastPlan system result in a lateral offset error.
Mar 3, 2011Not classifiedZ-2063-2011Software change controlThe optical guidance platform may not be properly enforcing a 24 hour time limit between optical camera recalibrations.
Mar 3, 2011Not classifiedZ-2176-2011Software designThe anomaly that has been identified with the Optical Guidance Platform (OGP) software may not be always displaying the correct transfer date on the patient file.
Jan 26, 2009Not classifiedZ-0888-2011Device DesignPotential patient impact -- limit switches for Floorstand may be inadequate for some models and allow for potential impact.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 6 ancestors has a recall.
  • Of its descendants, K142560 (Varian Medical Systems, Inc., 2014) has gone furthest, with 1 descendant 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. 2007, this device’s year, is highlighted.

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?

Varian Medical System's Optical Guidance Platform (OGP) is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.

Indications for use as stated in the FDA summary.

More from Varian Medical Systems, Inc.

172 FDA decisions under this applicant name. See the company

  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K260750Virtual Cone (1.0)Varian Medical Systems, Inc. · 2026
  • K253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc. · 2026
  • K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc. · 2026
  • K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc. · 2026

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/K071360 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071360: Optical Guidance Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071360

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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