510(k) · Cleared
ClearedAdac PINNACLE3TM Radiation Therapy Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adac Laboratories · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Apr 7, 2000 as substantially equivalent to K951581 (Adac Laboratories, 1996) and 4 other predicates after a 141-day review. Its family tree reaches back 3 generations to 1992. 79 later devices descend from it.
- Decided
- Apr 7, 2000
- Review
- 141 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K914698 (1992). 11 ancestors in all, the oldest K894706 (1989). 79 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 2 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 1 generation backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- This deviceK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- Descendant · cites it directly · 47 of its ownK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- Descendant · cites it directly · 44 of its ownK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
- Descendant · 2 generations on · 39 of its ownK041577 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · Recalled
- Descendant · 2 generations on · 32 of its ownK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
- Descendant · 3 generations on · 29 of its ownK080799 Atlas-Based AutosegmentationComputerized Medical Systems, Inc. · 2008
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K013112Focal SimComputerized Medical Systems, Inc. · 2001 · cites it directly47descendants
- K032724PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · cites it directly44descendants
- K041577PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · 2 generations on39descendants
- K022036Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002 · 2 generations on32descendants
- K080799Atlas-Based AutosegmentationComputerized Medical Systems, Inc. · 2008 · 3 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −2 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −1 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| 0 (this device) | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| +1 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| +1 | K032724 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2003 | 1 |
| +2 | K041577 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2004 | 7 |
| +2 | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +3 | K080799 | Atlas-Based Autosegmentation | Computerized Medical Systems, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 0 |
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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951581 | PINNACLE3 Apex Our OCR of the scanned summary read K951518, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Pinnacle® Apex Treatment Planning System”. | 1996 |
| * | K926008 | Pinnacle 3Summary page 1…sification name: Accelerator, Linear, Medical (per 21CFR section 892.5050) Predicate Devices: Pinnacle® Apex Treatment Planning System, K951518 ADAC Pinnacle’ Software, K926008 ACQPlan System, K974770 Device Description: Pinnacle® Radiation Treatment Planning Software is a system composed of a Sun Unix… | 1994 |
| * | K974770 | AcqplanSummary page 1…tor, Linear, Medical (per 21CFR section 892.5050) Predicate Devices: Pinnacle® Apex Treatment Planning System, K951518 ADAC Pinnacle’ Software, K926008 ACQPlan System, K974770 Device Description: Pinnacle® Radiation Treatment Planning Software is a system composed of a Sun Unix workstation running the S… | 1998 |
| * | K982821 | MMS Therpacplus B3DTUI Model Number 6.7Summary page 2…etary and Confidential 5.0 Pinnacle® RTP 510(k) Notification ADAC Laboratories November 1999 000039 ACQPlan 3D RTP System (K974770), MMS TherPac PLUS (K982821), and 1.M.S. Dose Calc. 1.02 (K990833). Summary of Non-clinical Tests Verification and Validation testing were completed in com… | 1998 |
| * | K990833 | Dose Calc, Model VS. 1.02Summary page 2…RTP 510(k) Notification ADAC Laboratories November 1999 000039 ACQPlan 3D RTP System (K974770), MMS TherPac PLUS (K982821), and 1.M.S. Dose Calc. 1.02 (K990833). Summary of Non-clinical Tests Verification and Validation testing were completed in compliance with ADAC Laboratories procedu… | 1999 |
What descends from it? (79)
See all 795 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K013112 (Computerized Medical Systems, Inc., 2001) has gone furthest, with 47 descendants of its own.
- 4 other devices also cite its predicate K951581.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
Pinnacle®™ Radiation Therapy Planning Software is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle® Radiation Therapy Planning Software assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The device is indicated for use in…
Read the full statement (114 words)
Pinnacle®™ Radiation Therapy Planning Software is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes.
Pinnacle® Radiation Therapy Planning Software assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues.
The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care.
Plans generated using this software are used in the determination of the course of a patient’s radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993923: Adac PINNACLE3TM Radiation Therapy Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993923
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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