510(k) · Cleared
ClearedMIM - SPECTRA Quant
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 Jun 22, 2018 as substantially equivalent to K172218 (Mim Software, Inc., 2017) and 2 other predicates after an 85-day review. Its family tree reaches back 12 generations to 1996. 1 of the 140 devices in its family, counting itself, has a Class I recall. 54 later devices descend from it.
- Decided
- Jun 22, 2018
- Review
- 85 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K954874 (1996). 85 ancestors in all, the oldest K885054 (1989). 54 later devices descend from it, 2 citing it directly. 1 of the 140 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 8 generations between
- 3 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 2 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 1 generation backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- This deviceK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- Descendant · cites it directly · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- Descendant · 2 generations on · 30 of its ownK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- Descendant · cites it directly · 14 of its ownK190379 MIM on LinuxMim Software, Inc. · 2019
- Descendant · 3 generations on · 6 of its ownK193562 AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. · 2020
- Descendant · 2 generations on · 6 of its ownK193252 Contour ProtegeAIMim Software, Inc. · 2020
Show all 12 generations
- Root · 12 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 11 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 10 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 9 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 8 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 7 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 6 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 5 generations backK062163 MimviewerMimvista Corp. · 2006
- 4 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 3 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 2 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 1 generation backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- This deviceK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…2 generations back · 1999
Most influential descendants
Showing 5 of 54 · See all- K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · cites it directly53descendants
- K191928AccuContourXiamen Manteia Technology, Ltd. · 2020 · 2 generations on30descendants
- K190379MIM on LinuxMim Software, Inc. · 2019 · cites it directly14descendants
- K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. · 2020 · 3 generations on6descendants
- K193252Contour ProtegeAIMim Software, Inc. · 2020 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −11 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −10 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −9 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −8 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −7 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −6 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −5 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −4 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −3 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −2 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −1 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| 0 (this device) | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| +1 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| +2 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
| +1 | K190379 | MIM on Linux | Mim Software, Inc. | 2019 | — |
| +3 | K193562 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +2 | K193252 | Contour ProtegeAI | Mim Software, Inc. | 2020 | — |
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 | 4 | 0 |
| 1999 | 3 | 1 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 7 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 8 | 0 |
| 2025 | 9 | 0 |
| 2026 | 9 | 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 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 |
|---|---|---|---|
| * | K172218 | MIM – Y90 DosimetrySummary page 4…Number / Product Code: 21 CFR 892.2050 Product Code LLZ Classification Name: System, Imaging Processing, Radiological Predicate Devices K172218 MIM – Y90 Dosimetry MIM Software Inc. K023190 E.CAM Computer / e.soft Work… | 2017 |
| * | K023190 | E.Cam Computer / E.Soft WorkstationSummary page 4…System, Imaging Processing, Radiological Predicate Devices K172218 MIM – Y90 Dosimetry MIM Software Inc. K023190 E.CAM Computer / e.soft Workstation Siemens K162483 Symbia Intevo Bold (xSPECT Quantificat… | 2002 |
| * | K162483 | Symbia Intevo BoldSummary page 4…72218 MIM – Y90 Dosimetry MIM Software Inc. K023190 E.CAM Computer / e.soft Workstation Siemens K162483 Symbia Intevo Bold (xSPECT Quantification) Siemens Intended Use MIM software is intended for trained med… | 2017 |
What descends from it? (54)
See all 542 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 · 2 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 28 of the 85 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K182624 (Mim Software, Inc., 2018) has gone furthest, with 53 descendants of its own.
- 3 other devices also cite its predicate K172218.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 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…
Read the full statement (265 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).
Post-treatment dose calculation and evaluation of permanent Yttrium-90 (Y90) microsphere implants.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180815: MIM - SPECTRA Quant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180815
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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