510(k) Report

510(k) · Cleared

Cleared

MMS Therpacplus B3DTUI Model Number 6.7

K982821510(k) TraditionalCleared Nov 5, 199886-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

Multimedia Medical Systems, Inc. · MUJ System, Planning, Radiation Therapy Treatment

Cleared on Nov 5, 1998 as substantially equivalent to K930506 (Pinecliff Assoc., 1994) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1993. 165 later devices descend from it.

Decided
Nov 5, 1998
Review
86 days
Class
Class II
Product code
MUJ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K924240 (1993). 2 ancestors in all. 165 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor2003: 4 descendants cleared2000: 1 descendant cleared2001: 2 descendants cleared2015: 6 descendants cleared2013: 3 descendants cleared2011: 6 descendants cleared2009: 7 descendants cleared2004: 4 descendants cleared2002: 2 descendants cleared2007: 2 descendants cleared2006: 6 descendants cleared2016: 5 descendants cleared2018: 9 descendants cleared2017: 4 descendants cleared2019: 7 descendants cleared2023: 14 descendants cleared2008: 3 descendants cleared2021: 13 descendants cleared2020: 9 descendants cleared2022: 10 descendants cleared2005: 1 descendant cleared2010: 4 descendants cleared2025: 11 descendants cleared2024: 10 descendants cleared2012: 5 descendants cleared2014: 3 descendants cleared2026: 14 descendants clearedK924240 · Prowess 2000 · Small Systems Group, Inc. · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 9 descendants3 generations forward: 13 descendants4 generations forward: 18 descendants5 generations forward: 23 descendants6 generations forward: 42 descendants7 generations forward: 19 descendants8 generations forward: 9 descendants9 generations forward: 10 descendants10 generations forward: 10 descendants11 generations forward: 4 descendants12 generations forward: 2 descendants13 generations forward: 3 descendants K924240 · Prowess 2000 · Small Systems Group, Inc. · 19930+5+10
  1. Root · 1 generation backK924240 Prowess 2000Small Systems Group, Inc. · 1993
  2. This deviceK982821 MMS Therpacplus B3DTUI Model Number 6.7Multimedia Medical Systems, Inc. · 1998
  3. Descendant · cites it directly · 83 of its ownK030534 Variseed 7.1Varian Medical Systems · 2003 · Recalled
  4. Descendant · 2 generations on · 79 of its ownK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
  5. Descendant · cites it directly · 79 of its ownK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
  6. Descendant · 3 generations on · 68 of its ownK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
  7. Descendant · 3 generations on · 67 of its ownK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017

Showing 5 of 165 descendants. See all descendants

Descendants cleared per year

2000: 12001: 22002: 22003: 42004: 42005: 12006: 62007: 22008: 32009: 72010: 42011: 62012: 52013: 32014: 32015: 62016: 52017: 42018: 92019: 72020: 92021: 132022: 102023: 142024: 102025: 112026: 14
2000high 14 (2023) · low 1 (2000)2026

Most influential descendants

Showing 5 of 165 · See all
  • K030534Variseed 7.1Varian Medical Systems · 2003 · cites it directly83descendants
  • K103576Mim 5.2 (Brachy)Mim Software, Inc. · 2011 · 2 generations on79descendants
  • K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000 · cites it directly79descendants
  • K151913MIM-Thin Client (mobile)Mim Software, Inc. · 2016 · 3 generations on68descendants
  • K172218MIM – Y90 DosimetryMim Software, Inc. · 2017 · 3 generations on67descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K924240Prowess 2000Small Systems Group, Inc.1993—
0 (this device)K982821MMS Therpacplus B3DTUI Model Number 6.7Multimedia Medical Systems, Inc.1998—
+1K030534Variseed 7.1Varian Medical Systems20031
+2K103576Mim 5.2 (Brachy)Mim Software, Inc.2011—
+1K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories2000—
+3K151913MIM-Thin Client (mobile)Mim Software, Inc.2016—
+3K172218MIM – Y90 DosimetryMim Software, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200120
200220
200340
200440
200510
200660
200720
200830
200970
201040
201160
201250
201330
201430
201560
201650
201740
201890
201970
202090
2021130
2022100
2023140
2024100
2025110
2026140
FIG. 1 — Lineage of K982821, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (2)

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
*K930506Therpac Radiotherapy Treatment Planning System
Summary page 1
…rsion 6.7 Classification Name: Treatment planning computer, CFR 892.5050 Predicate Devices: Multimedia Medical Systems “Therpac Radiotherapy Treatment Planning System”, K930506 SSGI, “Prowess 2000, K924240 Device Description: Hardware Platform and Operating System: The application runs on standard Intel…
Pinecliff Assoc.1994—
*K924240Prowess 2000
Summary page 1
…: Treatment planning computer, CFR 892.5050 Predicate Devices: Multimedia Medical Systems “Therpac Radiotherapy Treatment Planning System”, K930506 SSGI, “Prowess 2000, K924240 Device Description: Hardware Platform and Operating System: The application runs on standard Intel PCs under Microsoft Windows®…
Small Systems Group, Inc.1993—

Also cleared against K930506: 1 other device →

What descends from it? (165)

See all 165

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

NumberDeviceApplicantDecidedDescendants
K030534Variseed 7.1Varian Medical Systems200383
K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories200079
K012017Variseed 7.0Varian Medical Systems20011

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 2 ancestors has a recall.
  • Of its descendants, K030534 (Varian Medical Systems, 2003) has gone furthest, with 83 descendants of its own.
  • 1 other device also cites its predicate K930506.

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 MMS - TherpacPLUS B3DTUTI is a software application for pre-operative planning and post-operative evaluation of permanent implant brachytherapy procedures for the treatment of prostate cancer. It assists physicians and medical physicists in pre-planning the patient’s implant procedure and evaluating the actual post-operative results of the procedure.

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. “K982821: MMS Therpacplus B3DTUI Model Number 6.7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982821

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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