510(k) Report

510(k) · Cleared

Cleared

PINNACLE3 Apex

K951581510(k) TraditionalCleared Apr 8, 1996370-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

Adac Laboratories · IYE Accelerator, Linear, Medical

Cleared on Apr 8, 1996 as substantially equivalent to K926008 (Adac Laboratories, 1994) and 2 other predicates after a 370-day review. Its family tree reaches back 1 generation to 1989. 83 later devices descend from it.

Decided
Apr 8, 1996
Review
370 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K894706 (1989). 3 ancestors in all. 83 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1990: 1 other ancestor2009: 7 descendants cleared1998: 2 descendants cleared2000: 1 descendant cleared1997: 1 descendant cleared2004: 4 descendants cleared2003: 3 descendants cleared2001: 1 descendant cleared2002: 2 descendants cleared2007: 2 descendants cleared2006: 6 descendants cleared2008: 3 descendants cleared2005: 1 descendant cleared2010: 4 descendants cleared2011: 5 descendants cleared2012: 5 descendants cleared2013: 2 descendants cleared2020: 4 descendants cleared2016: 3 descendants cleared2015: 4 descendants cleared2014: 3 descendants cleared2018: 4 descendants cleared2023: 3 descendants cleared2019: 2 descendants cleared2017: 2 descendants cleared2021: 3 descendants cleared2022: 2 descendants cleared2024: 1 descendant cleared2026: 3 descendants clearedK894706 · HT-Res RTP System · Adac Laboratories · 19891990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 4 descendants3 generations forward: 6 descendants4 generations forward: 8 descendants5 generations forward: 8 descendants6 generations forward: 19 descendants7 generations forward: 8 descendants8 generations forward: 4 descendants9 generations forward: 7 descendants10 generations forward: 5 descendants11 generations forward: 4 descendants12 generations forward: 2 descendants13 generations forward: 3 descendants K894706 · HT-Res RTP System · Adac Laboratories · 19890+5+10
  1. Root · 1 generation backK894706 HT-Res RTP SystemAdac Laboratories · 1989
  2. This deviceK951581 PINNACLE3 ApexAdac Laboratories · 1996
  3. Descendant · cites it directly · 79 of its ownK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
  4. Descendant · 2 generations on · 47 of its ownK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
  5. Descendant · 2 generations on · 44 of its ownK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
  6. Descendant · 3 generations on · 39 of its ownK041577 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · Recalled
  7. Descendant · 3 generations on · 32 of its ownK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002

Showing 5 of 83 descendants. See all descendants

Descendants cleared per year

1997: 11998: 22000: 12001: 12002: 22003: 32004: 42005: 12006: 62007: 22008: 32009: 72010: 42011: 52012: 52013: 22014: 32015: 42016: 32017: 22018: 42019: 22020: 42021: 32022: 22023: 32024: 12026: 3
1997high 7 (2009) · low 0 (1999)2026

Most influential descendants

Showing 5 of 83 · See all
  • K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000 · cites it directly79descendants
  • K013112Focal SimComputerized Medical Systems, Inc. · 2001 · 2 generations on47descendants
  • K032724PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · 2 generations on44descendants
  • K041577PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · 3 generations on39descendants
  • K022036Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002 · 3 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K894706HT-Res RTP SystemAdac Laboratories1989—
0 (this device)K951581PINNACLE3 ApexAdac Laboratories1996—
+1K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories2000—
+2K013112Focal SimComputerized Medical Systems, Inc.200110
+2K032724PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories20031
+3K041577PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories20047
+3K022036Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199820
200010
200110
200220
200330
200440
200510
200660
200720
200830
200970
201040
201150
201250
201320
201430
201540
201630
201720
201840
201920
202040
202130
202220
202330
202410
202630
FIG. 1 — Lineage of K951581, 1989–2026Source: 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? (3)

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
*K926008Pinnacle 3
Summary page 1
…iation treatment of benign or malignant disease processes. The APEX software system is an extensior;. and enhancement of the currently marketed ADAC Pinnacle3 software (K926008), which also is also a radiation treatment software with a similar array of imaging, display, and dose computation capabilities.…
Adac Laboratories1994—
*K894706HT-Res RTP System
Summary page 1
…apy, external electron beam, and external photon beam treatment planning capabilities. The predicate devices for the additional intended uses are the ADAC XL CAD Plan (K894706) and Precision Therapy Inc. Render-Plan 3-D (K894722). Each of the intended uses are discussed below. B. STEREOTACTIC RADIOSURGE…
Adac Laboratories1989—
*K894722Renner-Plan
Summary page 1
…m treatment planning capabilities. The predicate devices for the additional intended uses are the ADAC XL CAD Plan (K894706) and Precision Therapy Inc. Render-Plan 3-D (K894722). Each of the intended uses are discussed below. B. STEREOTACTIC RADIOSURGERY The Pinnacle3 is the predicate device for the APE…
W.D. Renner Consulting Co.1990—

Also cleared against K926008: 3 other devices →

What descends from it? (83)

See all 83

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

NumberDeviceApplicantDecidedDescendants
K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories200079
K973936Focus RTP SystemComputerized Medical Systems, Inc.19981
K964206Nucletron Plato External Beam Planning RTS V2 and RTS 3D V2Nucletron Corp.19971
K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A.20090
K040688Standard Imaging E.Imrt CalculatorStandard Imaging, Inc.20040

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 3 ancestors has a recall.
  • Of its descendants, K993923 (Adac Laboratories, 2000) has gone furthest, with 79 descendants of its own.
  • 3 other devices also cite its predicate K926008.

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?

This software device is intended to assist in foermulating radiation treatment plans for modalities including stereotactic radiosurgery, external photon beam, external electron beam, and brachytherapy radiation treatment of benign or malignant disease processes.

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 K926008

3 other devices cite the same predicate.

  • K993675Peregrine Radiation Therapy Dose Calculation SystemNomos Corp. · 2000
  • K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
  • K970236Theraplan Plus Version 1.2Theratronics, Inc. · 1997

More from Adac Laboratories

88 FDA decisions under this applicant name. See the company

  • K062298Apollo Gamma Camera SystemAdac Laboratories · 20061 Class I recall
  • K061029Jetstream WorkspaceAdac Laboratories · 20061 recall
  • K060020Autoquant PlusAdac Laboratories · 2006
  • K051351Precedence Spect/CT Imaging SystemAdac Laboratories · 20051 recall
  • K042880Jetstream WorkspaceAdac Laboratories · 20041 recall

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/K951581 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951581: PINNACLE3 Apex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951581

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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