510(k) · Cleared
ClearedMetron-CP/MD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eponatech, LLC · LLZ System, Image Processing, Radiological
Cleared on Dec 20, 2011 as substantially equivalent to K070618 (Oehm Und Rehbein GmbH, 2007) and 1 other predicate after a 382-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Dec 20, 2011
- Review
- 382 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K896095 (1990). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 4 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 3 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 2 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 1 generation backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- This deviceK103554 Metron-CP/MDEponatech, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −5 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −4 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −3 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −2 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −1 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| 0 (this device) | K103554 | Metron-CP/MD | Eponatech, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 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.
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? (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 |
|---|---|---|---|
| * | K070618 | Dicompacs, Model 5Summary page 2…devices. Manufacturer Product Name 510O(k) No. Oehin and Rehibein dicomiPACS K07061 8I Viztek, Inc. Onyx-RAD Telemecdicine K003607 PAC S 11.… | 2007 |
| * | K003607 | Onyx-Rad Telemedicine PacsSummary page 2…510O(k) No. Oehin and Rehibein dicomiPACS K07061 8I Viztek, Inc. Onyx-RAD Telemecdicine K003607 PAC S 11. Device Description Metron-MD is a clinical software program that allows… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 4 other devices also cite its predicate K070618.
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?
The EponaTech Metron-CP/MD is a clinical imaging software application for use with DR and CR radiography systems, primarily focused on chiropractic and podiatry use. Metron-CP/MD processes images using state of the art wavelet filtering techniques from various imaging sources and then makes them available to display, edit, review, store, print and distribute using standard PC hardware. Metron-CP/MD stores and organizes the images (radiographs…
Read the full statement (231 words)
The EponaTech Metron-CP/MD is a clinical imaging software application for use with DR and CR radiography systems, primarily focused on chiropractic and podiatry use. Metron-CP/MD processes images using state of the art wavelet filtering techniques from various imaging sources and then makes them available to display, edit, review, store, print and distribute using standard PC hardware. Metron-CP/MD stores and organizes the images (radiographs, photographs, etc), and provides many value added features for review and analysis by trained medical practitioners. Advance imaging algorithms produce the best image possible from the imaging hardware. The filters are customizable by the user and organized in Metron-CP/MD'5 searchable database for later review. Metron-CP/MD also supports adding notes, taking accurate physical measurements, and producing other mark-ups to images to aid in analysis over time. Metron-CP/MD also allows the easy creation and editing of formatted, multi-page reports. Metron-CP/MD is currently intended for chiropractic, podiatry use, and general human radiography. It is not intendedfor mammography use.
Metron-CP/MD'5 features advance imaging algorithims, calibration and measurement tools, multi-imaging stitching, report generation, and full compliance with voluntary Digital Imaging and Communications in Medicine (DICOM) standards. The filters are customizable by the user and organized in Metron-CP!MD'5 searchable database for later review. Users then have the ability to put together mnulti-page formatted reports that can be used in connection with other medical professionals, or provided as reference to patients. (See 21 CER 892.2050)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103554: Metron-CP/MD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103554
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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