510(k) Report

510(k) · Cleared

Cleared

Ergo SRS

K031281510(k) TraditionalCleared Dec 23, 2003245-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

3D Line USA, Inc. · MUJ System, Planning, Radiation Therapy Treatment

Cleared on Dec 23, 2003 as substantially equivalent to K010784 (Nucletron Corp., 2001) after a 245-day review. Its family tree reaches back 1 generation to 2001. 30 later devices descend from it.

Decided
Dec 23, 2003
Review
245 days
Class
Class II
Product code
MUJ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K010784 (2001). 30 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2014: 1 descendant cleared2009: 3 descendants cleared2011: 1 descendant cleared2013: 1 descendant cleared2010: 1 descendant cleared2015: 1 descendant cleared2018: 2 descendants cleared2020: 3 descendants cleared2019: 2 descendants cleared2023: 4 descendants cleared2021: 4 descendants cleared2025: 3 descendants cleared2022: 2 descendants cleared2026: 1 descendant clearedK010784 · Plato SRS Stereotactic Radiosurgery Planning System,Model 2.0, Plato Ifs Image Fusion Software, Model 2.1 · Nucletron Corp. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 6 descendants3 generations forward: 3 descendants4 generations forward: 4 descendants5 generations forward: 6 descendants6 generations forward: 3 descendants7 generations forward: 2 descendants8 generations forward: 2 descendants9 generations forward: 2 descendants10 generations forward: 1 descendant K010784 · Plato SRS Stereotactic Radiosurgery Planning System,Model 2.0, Plato Ifs Image Fusion Software, Model 2.1 · Nucletron Corp. · 20010+5+10
  1. Root · 1 generation backK010784 Plato SRS Stereotactic Radiosurgery Planning System,Model 2.0, Plato…Nucletron Corp. · 2001
  2. This deviceK031281 Ergo SRS3D Line USA, Inc. · 2003
  3. Descendant · cites it directly · 29 of its ownK080601 Ergo++ Version 1.73D Line Medical Systems S.R.L. · 2008 · Recalled
  4. Descendant · 2 generations on · 13 of its ownK141572 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · Recalled
  5. Descendant · 3 generations on · 12 of its ownK183034 MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · Recalled
  6. Descendant · 2 generations on · 12 of its ownK091179 Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · Recalled
  7. Descendant · 4 generations on · 8 of its ownK203172 MOSAIQ Oncology Information SystemElekta Solutions AB · 2020 · Recalled

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2008: 12009: 32010: 12011: 12013: 12014: 12015: 12018: 22019: 22020: 32021: 42022: 22023: 42025: 32026: 1
2008high 4 (2021) · low 0 (2012)2026

Most influential descendants

Showing 5 of 30 · See all
  • K080601Ergo++ Version 1.73D Line Medical Systems S.R.L. · 2008 · cites it directly29descendants
  • K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · 2 generations on13descendants
  • K183034MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · 3 generations on12descendants
  • K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · 2 generations on12descendants
  • K203172MOSAIQ Oncology Information SystemElekta Solutions AB · 2020 · 4 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010784Plato SRS Stereotactic Radiosurgery Planning System,Model 2.0, Plato Ifs Image…Nucletron Corp.2001—
0 (this device)K031281Ergo SRS3D Line USA, Inc.2003—
+1K080601Ergo++ Version 1.73D Line Medical Systems S.R.L.20082
+2K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc.201411
+3K183034MOSAIQ Oncology Information SystemElekta, Inc.20182
+2K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc.20095
+4K203172MOSAIQ Oncology Information SystemElekta Solutions AB20201

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200930
201010
201110
201310
201410
201510
201820
201920
202030
202140
202220
202340
202530
202610
FIG. 1 — Lineage of K031281, 2001–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K010784Plato SRS Stereotactic Radiosurgery Planning System,Model 2.0, Plato Ifs Image Fusion…
Summary page 1
…atment planning module Classification: Medical charged-particle radiation therapy system, Class II Sec. 21 CFR 892.5050 Predicate Device: PLATO SRS V2, K010784 Manufactured by: Nucletron Corporation, 7080 Columbia Gateway Drive, Columbia, MD 21046-2133 Description of th…
Nucletron Corp.2001—

Also cleared against K010784: 2 other devices →

What descends from it? (30)

See all 30

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080601Ergo++ Version 1.73D Line Medical Systems S.R.L.200829

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?

  • Its one ancestor has no recall.
  • Of its descendants, K080601 (3D Line Medical Systems S.R.L., 2008) has gone furthest, with 29 descendants of its own.
  • 2 other devices also cite its predicate K010784.

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?

ERGO SRS is stereotactic radiosurgery module for DMLCIV-ERGO (KOO1 163). It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3 dimensional radiation therapy.

Indications for use as stated in the FDA summary.

Also cleared against K010784

2 other devices cite the same predicate.

  • K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A. · 2009
  • K030821Simuplan Treatment Planning System, Model V. 7.5Simuplan S.L. · 2003

More from 3D Line USA, Inc.

6 FDA decisions under this applicant name. See the company

  • K034051Dynatrac, Cod. 50-1A3D Line USA, Inc. · 2004
  • K031631Stereotactic Body Frame, Model Cod. 70-1A3D Line USA, Inc. · 2003
  • K013535Evtool Model # V. 1.03D Line USA, Inc. · 2002
  • K0112553D Line Sterotactic Hardware Accessories3D Line USA, Inc. · 20012 recalls
  • K001163DMLC IV-Ergo3D Line USA, Inc. · 20003 recalls

Recent decisions in MUJ

The MUJ category page

  • K261655RT Elements (4.6)Brainlab SE · 2026
  • K260750Virtual Cone (1.0)Varian Medical Systems, Inc. · 2026
  • K253050RadOncAIInformai · 2026
  • K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V. · 2026
  • K252784eXaSkin PlusAnatomical Geometry S.L. · 2026

https://510kreport.com/device/K031281 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031281: Ergo SRS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031281

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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