510(k) · Cleared
ClearedMFI-Cardiac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Multifunctional Imaging, LLC · LLZ System, Image Processing, Radiological
Cleared on Feb 5, 2018 as substantially equivalent to K101279 (Invia, 2010) after an 84-day review. Its family tree reaches back 7 generations to 1991. 1 of the 32 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 5, 2018
- Review
- 84 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913770 (1991). 31 ancestors in all, the oldest K892358 (1989). No later device cites it as a predicate yet. 1 of the 32 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 5 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 4 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 3 generations backK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- 2 generations backK083327 Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc. · 2009
- 1 generation backK101279 CORRIDOR4DM V2010 Model: V2010Invia · 2010
- This deviceK173512 MFI-CardiacMultifunctional Imaging, LLC · 2018
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…3 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −5 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −4 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| −2 | K083327 | Syngocirculation Dynamicpet, Version 1.0 | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −1 | K101279 | CORRIDOR4DM V2010 Model: V2010 | Invia | 2010 | — |
| 0 (this device) | K173512 | MFI-Cardiac | Multifunctional Imaging, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 1 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101279 | CORRIDOR4DM V2010 Model: V2010Summary page 4…communications system Regulation number: 21 CFR 892.1200 / 21 CFR 892.2050 Product Code: KPS / LLZ Predicate Device: Corridor4DM v2010 (K101279) Associated FDA Document Number: Q120397 (Pre-Sub dated Dec. 14, 2012) 2. Device Description MFI–Cardiac is a… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 4.5 years on median.
- 8 of the 31 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K101279.
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?
The MFI–Cardiac application is intended to provide processing of rest and stress myocardial perfusion positron emission tomography (PET) images with approved radiotracers that have been acquired with a single-scan or fast back-to-back scans without waiting for radiotracer decay between scans. The application models measurements of tracer uptake over time to aid in the processing of the images. Co-registration or fusion of volumetric data is provided as a quality control. The processed output images are reviewed on other devices by qualified medical professionals trained in the use of medical imaging devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173512: MFI-Cardiac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173512
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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