510(k) · Cleared
ClearedMIM-Ablation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mim Software, Inc. · QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Cleared on Oct 7, 2022 as substantially equivalent to K190379 (Mim Software, Inc., 2019) and 1 other predicate after a 249-day review. Its family tree reaches back 15 generations to 1996. 1 of the 113 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Oct 7, 2022
- Review
- 249 days
- Class
- Class II
- Product code
- QTZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K954874 (1996). 108 ancestors in all, the oldest K885054 (1989). 4 later devices descend from it, 2 citing it directly. 1 of the 113 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 11 generations between
- 3 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 2 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 1 generation backK190379 MIM on LinuxMim Software, Inc. · 2019
- This deviceK220256 MIM-AblationMim Software, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK232862 MIM – Monte Carlo DosimetryMim Software, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK243012 MIM – Symphony HDR FusionMim Software, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK251883 MIM – LesionID ProMim Software, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK232514 MIM – Dose AnalysisMim Software, Inc. · 2024
Show all 15 generations
- Root · 15 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 14 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 13 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 12 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 11 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 10 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 9 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 8 generations backK062163 MimviewerMimvista Corp. · 2006
- 7 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 6 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 5 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 4 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 3 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 2 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 1 generation backK190379 MIM on LinuxMim Software, Inc. · 2019
- This deviceK220256 MIM-AblationMim Software, Inc. · 2022
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…4 generations back · 1999
Most influential descendants
Showing 4 of 4 · See all- K232862MIM – Monte Carlo DosimetryMim Software, Inc. · 2024 · cites it directly2descendants
- K243012MIM – Symphony HDR FusionMim Software, Inc. · 2024 · 2 generations on1descendant
- K251883MIM – LesionID ProMim Software, Inc. · 2025 · 3 generations on0descendants
- K232514MIM – Dose AnalysisMim Software, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −14 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −13 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −12 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −11 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −10 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −9 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −8 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −7 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −6 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −5 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −4 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −3 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| −2 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| −1 | K190379 | MIM on Linux | Mim Software, Inc. | 2019 | — |
| 0 (this device) | K220256 | MIM-Ablation | Mim Software, Inc. | 2022 | — |
| +1 | K232862 | MIM – Monte Carlo Dosimetry | Mim Software, Inc. | 2024 | — |
| +2 | K243012 | MIM – Symphony HDR Fusion | Mim Software, Inc. | 2024 | — |
| +3 | K251883 | MIM – LesionID Pro | Mim Software, Inc. | 2025 | — |
| +1 | K232514 | MIM – Dose Analysis | Mim Software, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 1 |
| 2000 | 11 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 3 | 0 |
| 2025 | 1 | 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.
1 device in this family has a Class I recall. 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 QTZ device
- #1 K252947 HistoSonics® Planning Toolscore 14.4 · 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190379 | MIM on LinuxSummary page 5…Number / Product Code: 21 CFR 892.2050 Product Code LLZ Secondary Classification Name: System, Imaging Processing, Radiological Predicate Devices Primary: K190379 MIM on Linux MIM Software Inc. Secondaries: K202297 Aline A… | 2019 |
| * | K202297 | Aline Ablation IntelligenceSummary page 5…System, Imaging Processing, Radiological Predicate Devices Primary: K190379 MIM on Linux MIM Software Inc. Secondaries: K202297 Aline Ablation Intelligence Mirada Medical Ltd. Intended Use MIM software is intended for tr… | 2020 |
| † | K103576 | Mim 5.2 (Brachy) | 2011 |
| † | K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe… | 2020 |
| † | K160942 | Sonablate | 2016 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 4 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 32 of the 108 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K232862 (Mim Software, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K190379.
How does its category compare?
All QTZ devicesQTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QTZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QTZ
351in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QTZ
No recall names QTZ since 2007.
Adverse event reports per year · QTZ
No MAUDE report names QTZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 3 | 351 | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
MIM 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 ACR/NEMA DICOM 3.0. MIM assists in the following indications: * Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. * Create, display and print reports…
Read the full statement (350 words)
MIM 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 ACR/NEMA DICOM 3.0. MIM 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 (not including radioactive microspheres).
* Calculating absorbed radiation dose as a result of administering a radionuclide.
* Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success.
When using device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If using with unapproved ones, this device should only be used for research purposes.
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/K220256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220256: MIM-Ablation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220256
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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