510(k) · Cleared
ClearedAcqplan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Sep 2, 1998 after a 254-day review. The FDA summary names no predicate by number. 86 later devices descend from it.
- Decided
- Sep 2, 1998
- Review
- 254 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 0
86 later devices descend from it, 2 citing it directly.
- This deviceK974770 AcqplanPhilips Medical Systems (Cleveland), Inc. · 1998
- Descendant · cites it directly · 79 of its ownK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- Descendant · 2 generations on · 47 of its ownK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 44 of its ownK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
- Descendant · 3 generations on · 39 of its ownK041577 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · Recalled
- Descendant · 3 generations on · 32 of its ownK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 86 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974770 | Acqplan | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
| +1 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| +2 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| +2 | K032724 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2003 | 1 |
| +3 | K041577 | PINNACLE3 Radiation Therapy Planning System | Adac Laboratories | 2004 | 7 |
| +3 | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 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 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 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?
The FDA summary names no predicate by number.
What descends from it? (86)
See all 862 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?
- Of its descendants, K993923 (Adac Laboratories, 2000) has gone furthest, with 79 descendants of its own.
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?
The ACQPLAN is an integrated 3-D RTP and simulation system embedded in a volumetric image processing computer environment. AcQPlan is intended to be used to plan radiation therapy treatments on linear accelerators and other similar teletherapy devices with x-ray beams of energies from 4 to 50 MV, cobalt-60, and electron beams with energies from 4 to 50 MeV of the entire human anatomy. It allows the treatment planner to employ such techniques as…
Read the full statement (256 words)
The ACQPLAN is an integrated 3-D RTP and simulation system embedded in a volumetric image processing computer environment. AcQPlan is intended to be used to plan radiation therapy treatments on linear accelerators and other similar teletherapy devices with x-ray beams of energies from 4 to 50 MV, cobalt-60, and electron beams with energies from 4 to 50 MeV of the entire human anatomy. It allows the treatment planner to employ such techniques as asymmetrically collimated fields, irregular fields, multi-leaf collimators, non-coplanar fields, bolus, fixed wedges, and Varian's enhanced dynamic wedges. It allows the treatment planner to take heterogeneities into account for photon beams using two versions of the Batho method or the Equivalent TAR (ETAR) method, and it uses a generalized Gaussian pencil beam model for electron beams. Using AcQPlan, the treatment planner can simultaneously visualize target and normal tissues and the computed 3-D dose distributions in great detail, on a real-time basis. The treatment planner develops treatment plans in a coordinate system accurately fixed to set-up marks on the patient, using CT and multi-modality information made possible by volumetric 3-D image processing. Tools for managing competing and complementary plans are provided. Tools, based on DVH plots, are provided for comparing competing plans. High quality DRRs and DCRs (digitally composited radiographs), with BEV and beam graphics superimposed, are generated to replace conventional simulator films. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
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/K974770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974770: Acqplan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974770
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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