510(k) · Cleared
ClearedMdxnet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cybermdx, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 9, 2006 as substantially equivalent to K012086 (Terarecon,Inc., 2001) and 3 other predicates after a 63-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Mar 9, 2006
- Review
- 63 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K945188 (1995). 9 ancestors in all, the oldest K941322 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 3 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 2 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- 1 generation backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- This deviceK060035 MdxnetCybermdx, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −3 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −2 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| −1 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| 0 (this device) | K060035 | Mdxnet | Cybermdx, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 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? (4)
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 |
|---|---|---|---|
| * | K012086 | Aquariusnet ServerSummary page 2…y standards under Investigational Review Board (IRB) approval and in the laboratory setting. The predicate devices are as follows • AquariusNet Server, Teracon, Inc., K012086 • TeraRecon IiVS, TeraRecon, Inc., K994329 • Imatron Ultra Access, Acculmage, 972903 * EchoTech 3D Imaging Systems, K013088… | 2001 |
| * | K994329 | Iivs Integrated Image Viewing StationSummary page 2…d (IRB) approval and in the laboratory setting. The predicate devices are as follows • AquariusNet Server, Teracon, Inc., K012086 • TeraRecon IiVS, TeraRecon, Inc., K994329 • Imatron Ultra Access, Acculmage, 972903 * EchoTech 3D Imaging Systems, K013088 These devices are substantially equivalent… | 2000 |
| * | K972903 | Imatron Ultra Access Workstation with Cardiac Software ExtensionsSummary page 2…g. The predicate devices are as follows • AquariusNet Server, Teracon, Inc., K012086 • TeraRecon IiVS, TeraRecon, Inc., K994329 • Imatron Ultra Access, Acculmage, 972903 * EchoTech 3D Imaging Systems, K013088 These devices are substantially equivalent in terms of basic design, features and inten… | 1997 |
| * | K013088 | Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech Quanticon…Summary page 2…• AquariusNet Server, Teracon, Inc., K012086 • TeraRecon IiVS, TeraRecon, Inc., K994329 • Imatron Ultra Access, Acculmage, 972903 * EchoTech 3D Imaging Systems, K013088 These devices are substantially equivalent in terms of basic design, features and intended use, though MDxPAC and MDxServer have… | 2002 |
| † | K010436 | Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model 01-0011 | 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 11 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 9 ancestors has a recall.
- 6 other devices also cite its predicate K012086.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
MDxNet is intended for use under physician's orders and/or oversight and management. MDxNet is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images in the adult and pediatric patient utilizing existing ultrasound systems. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 2D and 3D image processing. MDxNet is indicated to acquire, digitize, archive and…
Read the full statement (189 words)
MDxNet is intended for use under physician's orders and/or oversight and management.
MDxNet is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images in the adult and pediatric patient utilizing existing ultrasound systems. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 2D and 3D image processing. MDxNet is indicated to acquire, digitize, archive and retrieve single or sequences of 2D ultrasound images.
MDxNet is intended as a general purpose digital image processing and archiving tool for use in abdominal, pelvic, fetal, cardiac, peripheral vascular and neurovascular imaging.
MDxNet add-on indications are for the assessment of pulmonary function to acquire, analyze, store and retrieve this assessment in male/female adult and pediatric patients utilizing FDA approved Spirometry. MDxNet additional add-on will provide 12-lead resting electrocardiogram (ECG) which permits the detection of abnormalities in the transmission of the cardiac impulse through the heart muscle and serves as an important aid in the diagnosis of heart ailments through utilizing 12-lead ECG.
MDxNet intended use is for medical clinics, including though not limited to infirmary, hospital, military, remote and urban clinics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060035 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060035: Mdxnet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060035
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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