510(k) Report

510(k) · Cleared

Cleared

Acqplan

K974770510(k) TraditionalCleared Sep 2, 1998254-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

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.

Descendants, by year cleared 2002: 3 descendants cleared2000: 1 descendant cleared2016: 4 descendants cleared2003: 3 descendants cleared2001: 1 descendant cleared2009: 7 descendants cleared2004: 4 descendants cleared2007: 2 descendants cleared2006: 6 descendants cleared2019: 3 descendants cleared2008: 3 descendants cleared2020: 5 descendants cleared2005: 1 descendant cleared2010: 4 descendants cleared2011: 5 descendants cleared2022: 4 descendants cleared2012: 5 descendants cleared2013: 2 descendants cleared2015: 4 descendants cleared2014: 3 descendants cleared2018: 4 descendants cleared2023: 3 descendants cleared2017: 2 descendants cleared2021: 3 descendants cleared2024: 1 descendant cleared2026: 3 descendants cleared1995200020052010201520202025
  1. This deviceK974770 AcqplanPhilips Medical Systems (Cleveland), Inc. · 1998
  2. Descendant · cites it directly · 79 of its ownK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
  3. Descendant · 2 generations on · 47 of its ownK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
  4. Descendant · 2 generations on · 44 of its ownK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
  5. Descendant · 3 generations on · 39 of its ownK041577 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · Recalled
  6. 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

2000: 12001: 12002: 32003: 32004: 42005: 12006: 62007: 22008: 32009: 72010: 42011: 52012: 52013: 22014: 32015: 42016: 42017: 22018: 42019: 32020: 52021: 32022: 42023: 32024: 12026: 3
2000high 7 (2009) · low 0 (2025)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K974770AcqplanPhilips Medical Systems (Cleveland), Inc.1998—
+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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200110
200230
200330
200440
200510
200660
200720
200830
200970
201040
201150
201250
201320
201430
201540
201640
201720
201840
201930
202050
202130
202240
202330
202410
202630
FIG. 1 — Lineage of K974770, 1998–2026Source: 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 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. #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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?

The FDA summary names no predicate by number.

What descends from it? (86)

See all 86

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

NumberDeviceApplicantDecidedDescendants
K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories200079
K013644Acqplan 5.0Philips Medical Systems, Inc.20025

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 devices

MUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MUJ

10in 2025

2007: 42008: 92009: 162010: 112011: 92012: 82013: 52014: 92015: 132016: 52017: 72018: 72019: 92020: 92021: 112022: 82023: 102024: 92025: 102026 (partial year): 9
2007high 16 (2009) · low 4 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUJ

186in 2025

2007: 67 days median2008: 63 days median2009: 84 days median2010: 56 days median2011: 103 days median2012: 59 days median2013: 64 days median2014: 108 days median2015: 78 days median2016: 80 days median2017: 30 days median2018: 53 days median2019: 56 days median2020: 104 days median2021: 87 days median2022: 168 days median2023: 140 days median2024: 122 days median2025: 186 days median2026 (partial year): 233 days median
2007high 233 (2026) · low 30 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MUJ

2in 2023

2007: 42008: 102009: 112010: 232011: 172012: 42013: 62014: 22015: 72016: 132017: 42018: 32019: 42020: 22021: 42022: 32023: 22026 (partial year): 2
2007high 23 (2010) · low 0 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MUJ

21in 2025

2007: 242008: 512009: 242010: 782011: 732012: 392013: 332014: 352015: 302016: 272017: 162018: 252019: 252020: 262021: 152022: 222023: 762024: 92025: 21
2007high 78 (2010) · low 9 (2024)2025

MAUDE reports naming product code MUJ, 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
2007467424
20089631051
200916841124
201011562378
201191031773
2012859439
2013564633
20149108235
20151378730
20165801327
2017730416
2018753325
2019956425
20209104226
20211187415
20228168322
202310140276
2024912209
202510186021
202692332—

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.

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