510(k) · Cleared
ClearedMim 5.2 (Brachy)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mim Software, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 18, 2011 as substantially equivalent to K071964 (Mimvista Corp., 2007) and 2 other predicates after a 74-day review. Its family tree reaches back 8 generations to 1996. 79 later devices descend from it.
- Decided
- Feb 18, 2011
- Review
- 74 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K954874 (1996). 52 ancestors in all, the oldest K885054 (1989). 79 later devices descend from it, 7 citing it directly.
- Root · 8 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 7 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 6 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 5 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 4 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 3 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 2 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 1 generation backK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- This deviceK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
- Descendant · cites it directly · 68 of its ownK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- Descendant · cites it directly · 67 of its ownK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- Descendant · 2 generations on · 54 of its ownK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- Descendant · 2 generations on · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- Descendant · 3 generations on · 30 of its ownK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K151913MIM-Thin Client (mobile)Mim Software, Inc. · 2016 · cites it directly68descendants
- K172218MIM – Y90 DosimetryMim Software, Inc. · 2017 · cites it directly67descendants
- K180815MIM - SPECTRA QuantMim Software, Inc. · 2018 · 2 generations on54descendants
- K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · 2 generations on53descendants
- K191928AccuContourXiamen Manteia Technology, Ltd. · 2020 · 3 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −7 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −6 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −5 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −4 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −3 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −2 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −1 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| 0 (this device) | K103576 | Mim 5.2 (Brachy) | Mim Software, Inc. | 2011 | — |
| +1 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| +1 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| +2 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| +2 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| +3 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 10 | 0 |
| 2022 | 8 | 0 |
| 2023 | 10 | 0 |
| 2024 | 9 | 0 |
| 2025 | 11 | 0 |
| 2026 | 11 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K071964 | Mim 4.1 (Seastar)Summary page 1…ame: Medical Imaging Software Classification Name: System, Imaging Processing, Radiological Predicate Devices K071964 MIM 4.1 (SEASTAR) MIM Software Inc. (formerly MlMvista Cowp.) K992762 Brachyvision 6.0 Vari… | 2007 |
| * | K992762 | Brachyvision 6.0Summary page 1…System, Imaging Processing, Radiological Predicate Devices K071964 MIM 4.1 (SEASTAR) MIM Software Inc. (formerly MlMvista Cowp.) K992762 Brachyvision 6.0 Varian Medical Systems K030534 VaniSeed 7.1 Varian Medical Systems… | 2000 |
| * | K030534 | Variseed 7.1Summary page 1…evices K071964 MIM 4.1 (SEASTAR) MIM Software Inc. (formerly MlMvista Cowp.) K992762 Brachyvision 6.0 Varian Medical Systems K030534 VaniSeed 7.1 Varian Medical Systems Intended Use MIM 5.2 software is intended for trained medical p… | 2003 |
What descends from it? (79)
See all 797 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 52 ancestors have a recall of any class.
- Of its descendants, K151913 (Mim Software, Inc., 2016) has gone furthest, with 68 descendants of its own.
- 9 other devices also cite its predicate K071964.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
MIM 5.2 software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACRINEMA DICOM 3.0. MIM 5.2 assists in the following indications: * Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. * Create, display and print…
Read the full statement (260 words)
MIM 5.2 software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACRINEMA DICOM 3.0. MIM 5.2 assists in the following indications:
* Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.
* Create, display and print reports from medical images.
* Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
* Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
* Localization and definition of objects such as tumors and normal tissues in medical images.
* Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
* Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
* Planning and evaluation of permanent implant brachytherapy procedures.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103576: Mim 5.2 (Brachy).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103576
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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