510(k) · Cleared
ClearedAcqplan 5.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Sep 12, 2002 as substantially equivalent to K974770 (Philips Medical Systems (Cleveland), Inc., 1998) after a 311-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it.
- Decided
- Sep 12, 2002
- Review
- 311 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974770 (1998). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK974770 AcqplanPhilips Medical Systems (Cleveland), Inc. · 1998
- This deviceK013644 Acqplan 5.0Philips Medical Systems, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK151435 MRCATPhilips Medical Systems MR Finland · 2016
- Descendant · 2 generations on · 3 of its ownK182888 MRCAT PelvisPhilips Medical Systems MR Finland · 2019
- Descendant · 3 generations on · 2 of its ownK193109 MRCAT brainPhilips Medical Systems MR Finland · 2020
- Descendant · 4 generations on · 0 of its ownK211841 MRI PlannerSpectronic Medical AB · 2022
- Descendant · 4 generations on · 0 of its ownK214081 MRCAT Head & NeckPhilips OY · 2022
Most influential descendants
Showing 5 of 5 · See all- K151435MRCATPhilips Medical Systems MR Finland · 2016 · cites it directly4descendants
- K182888MRCAT PelvisPhilips Medical Systems MR Finland · 2019 · 2 generations on3descendants
- K193109MRCAT brainPhilips Medical Systems MR Finland · 2020 · 3 generations on2descendants
- K211841MRI PlannerSpectronic Medical AB · 2022 · 4 generations on0descendants
- K214081MRCAT Head & NeckPhilips OY · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974770 | Acqplan | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
| 0 (this device) | K013644 | Acqplan 5.0 | Philips Medical Systems, Inc. | 2002 | — |
| +1 | K151435 | MRCAT | Philips Medical Systems MR Finland | 2016 | — |
| +2 | K182888 | MRCAT Pelvis | Philips Medical Systems MR Finland | 2019 | — |
| +3 | K193109 | MRCAT brain | Philips Medical Systems MR Finland | 2020 | — |
| +4 | K211841 | MRI Planner | Spectronic Medical AB | 2022 | — |
| +4 | K214081 | MRCAT Head & Neck | Philips OY | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K974770 | AcqplanSummary page 1…is of comparable type and substantially equivalent to the legally marketed device, AcQPlan currently in commercial distribution under 5 1O(k) Document control Number K974770. 19 4. Device Description The AcQPlan 5.0 provides three-dimension… | 1998 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151435 | MRCAT | 2016 | 4 |
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?
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 5.0 is an integrated 3-D RTP and simulation system embedded in a volumetric image processing computer environment. AcQPlan 5.0 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 (240 words)
The AcQPlan 5.0 is an integrated 3-D RTP and simulation system embedded in a volumetric image processing computer environment. AcQPlan 5.0 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, and fixed wedges. It allows the treatment planner to take heterogeneities into account (CT only) 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 5 .O, 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 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 DRS and DCS (digitally reconstructed or composited simulation) images, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013644: Acqplan 5.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013644
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026