510(k) Report

510(k) · Cleared

Cleared

Module Integrated Radiotherapy System (Mirs)

K090182510(k) TraditionalCleared May 4, 200998-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

Nuclemed S.A. · MUJ System, Planning, Radiation Therapy Treatment

Cleared on May 4, 2009 as substantially equivalent to K010464 (Lifeline Software, Inc., 2001) and 9 other predicates after a 98-day review. Its family tree reaches back 4 generations to 1992.

Decided
May 4, 2009
Review
98 days
Class
Class II
Product code
MUJ
Recalls
None
Predicates
10

Its longest line of descent runs back 4 generations to K914698 (1992). 25 ancestors in all, the oldest K894706 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 2 other ancestors2003: 2 other ancestors2001: 2 other ancestors2000: 2 other ancestors1998: 3 other ancestors1996: 1 other ancestor1995: 3 other ancestors2002: 1 other ancestor1994: 2 other ancestors1990: 1 other ancestor1989: 1 other ancestor1993: 1 other ancestorK914698 · Setup Computer with Software V-1261,62 and 63 · K.S., Inc. · 1992K980904 · Mucheck Monitor Unit Validation Program · Medical Dosimetry Services, Inc. · 1998K990833 · Dose Calc, Model VS. 1.02 · Integrity Medical Software, Inc. · 1999K993923 · Adac PINNACLE3TM Radiation Therapy Planning System · Adac Laboratories · 2000198519901995200020052010
Other ancestors, by generation 1 generation back: 9 other ancestors2 generations back: 10 other ancestors3 generations back: 2 other ancestors K993923 · Adac PINNACLE3TM Radiation Therapy Planning System · Adac Laboratories · 2000K990833 · Dose Calc, Model VS. 1.02 · Integrity Medical Software, Inc. · 1999K980904 · Mucheck Monitor Unit Validation Program · Medical Dosimetry Services, Inc. · 1998K914698 · Setup Computer with Software V-1261,62 and 63 · K.S., Inc. · 19920
  1. Root · 4 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
  2. 3 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
  3. 2 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
  4. 1 generation backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
  5. This deviceK090182 Module Integrated Radiotherapy System (Mirs)Nuclemed S.A. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K914698Setup Computer with Software V-1261,62 and 63K.S., Inc.1992—
−3K980904Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc.1998—
−2K990833Dose Calc, Model VS. 1.02Integrity Medical Software, Inc.1999—
−1K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories2000—
0 (this device)K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199010
199310
199420
199530
199610
199830
200020
200120
200210
200320
200820
FIG. 1 — Lineage of K090182, 1992–2009Source: 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
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What was it cleared against? (10)

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
*K010464Radcalc, Model V.4.0Lifeline Software, Inc.2001—
*K082606Commissioning Data Management System (CDMS)
Summary page 1
…t Legally Marketed Device to Which Substantial Equivalence is Claimed: The MIRS TM unit is substantially equivalent (SE) to Rad Calc (KO10464) cleared in 2001, CDMS (K082606) cleared in 2008, PLATO SRS (KO 10784) cleared in 2001, FOCUS SRS (K973936 + K002147) cleared in 1998, IMSure (K031975) cleared i…
D3 Radiation Planning2008—
*K010784Plato SRS Stereotactic Radiosurgery Planning System,Model 2.0, Plato Ifs Image Fusion…Nucletron Corp.2001—
*K973936Focus RTP System
Summary page 1
…The MIRS TM unit is substantially equivalent (SE) to Rad Calc (KO10464) cleared in 2001, CDMS (K082606) cleared in 2008, PLATO SRS (KO 10784) cleared in 2001, FOCUS SRS (K973936 + K002147) cleared in 1998, IMSure (K031975) cleared in 2000, ERGO++ (K080601) cleared in 2008, ADAC Pinnacle3 (K951581) cleared…
Computerized Medical Systems, Inc.1998—
*K002147FOCUS
Summary page 1
…M unit is substantially equivalent (SE) to Rad Calc (KO10464) cleared in 2001, CDMS (K082606) cleared in 2008, PLATO SRS (KO 10784) cleared in 2001, FOCUS SRS (K973936 + K002147) cleared in 1998, IMSure (K031975) cleared in 2000, ERGO++ (K080601) cleared in 2008, ADAC Pinnacle3 (K951581) cleared in 1996, P…
Computerized Medical Systems, Inc.2000—
*K031975Imsure
Summary page 1
…(SE) to Rad Calc (KO10464) cleared in 2001, CDMS (K082606) cleared in 2008, PLATO SRS (KO 10784) cleared in 2001, FOCUS SRS (K973936 + K002147) cleared in 1998, IMSure (K031975) cleared in 2000, ERGO++ (K080601) cleared in 2008, ADAC Pinnacle3 (K951581) cleared in 1996, Pinnacle3 (K993923) cleared in 2000…
Prodigm, Inc.2003—
*K080601Ergo++ Version 1.7
Summary page 1
…d in 2001, CDMS (K082606) cleared in 2008, PLATO SRS (KO 10784) cleared in 2001, FOCUS SRS (K973936 + K002147) cleared in 1998, IMSure (K031975) cleared in 2000, ERGO++ (K080601) cleared in 2008, ADAC Pinnacle3 (K951581) cleared in 1996, Pinnacle3 (K993923) cleared in 2000, and the FOCUS RTP (K915691) clea…
3D Line Medical Systems S.R.L.20082
*K951581PINNACLE3 Apex
Summary page 1
…PLATO SRS (KO 10784) cleared in 2001, FOCUS SRS (K973936 + K002147) cleared in 1998, IMSure (K031975) cleared in 2000, ERGO++ (K080601) cleared in 2008, ADAC Pinnacle3 (K951581) cleared in 1996, Pinnacle3 (K993923) cleared in 2000, and the FOCUS RTP (K915691) cleared in 1995. Traditional Premarket No…
Adac Laboratories1996—
*K993923Adac PINNACLE3TM Radiation Therapy Planning System
Summary page 1
…, FOCUS SRS (K973936 + K002147) cleared in 1998, IMSure (K031975) cleared in 2000, ERGO++ (K080601) cleared in 2008, ADAC Pinnacle3 (K951581) cleared in 1996, Pinnacle3 (K993923) cleared in 2000, and the FOCUS RTP (K915691) cleared in 1995. Traditional Premarket Notification for MIRS, Nuclemed S.A.…
Adac Laboratories2000—
*K915691Focus RTP
Summary page 1
…98, IMSure (K031975) cleared in 2000, ERGO++ (K080601) cleared in 2008, ADAC Pinnacle3 (K951581) cleared in 1996, Pinnacle3 (K993923) cleared in 2000, and the FOCUS RTP (K915691) cleared in 1995. Traditional Premarket Notification for MIRS, Nuclemed S.A. Page…
Computerized Medical Systems, Inc.1995—

Also cleared against K010464: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 17 years and passes through 5 companies; a new generation was cleared every 6.0 years on median.
  • 2 of the 25 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K010464.

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. 2009, this device’s year, is highlighted.

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?

MIRS TM is used to create treatment plans for patients for whom radiation therapy has been prescribed. The system will calculate and display three dimensional radiation dose distributions within the patient for a given treatment plan set up. MIRS can be used for different treatment modalities of radiation therapy, as conventional therapy, Conformal Radiation Therapy, Intensity Modulated Radiation Therapy, and Radiosurgery with Conic Collimators.

Indications for use as stated in the FDA summary.

Also cleared against K010464

4 other devices cite the same predicate.

  • K090531Radcalc Software, Version 6.0Lifeline Software, Inc. · 2009
  • K082606Commissioning Data Management System (CDMS)D3 Radiation Planning · 2008
  • K031975ImsureProdigm, Inc. · 2003
  • K012227Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001

More from Nuclemed S.A.

2 FDA decisions under this applicant name. See the company

  • K090190Win-Neus Stereotactic Surgery Treatment Planning SystemNuclemed S.A. · 2009

Recent decisions in MUJ

The MUJ category page

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https://510kreport.com/device/K090182 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090182: Module Integrated Radiotherapy System (Mirs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090182

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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