510(k) · Cleared
ClearedCuattro Unomd
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cuattro, LLC · LLZ System, Image Processing, Radiological
Cleared on Mar 5, 2010 as substantially equivalent to K063188 (Del Medical Imaging Corp., 2006) after a 116-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.
- Decided
- Mar 5, 2010
- Review
- 116 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K900935 (1990). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK900935 DU Pont Linx Laser Imager W/the Linx NetworkingE.I. Dupont DE Nemours & Co., Inc. · 1990
- 3 generations backK964250 Linx Networking SystemSterling Diagnostic Imaging, Inc. · 1996
- 2 generations backK980970 Iirad Directray Operator ConsoleSterling Diagnostic Imaging, Inc. · 1998
- 1 generation backK063188 Del-ImsDel Medical Imaging Corp. · 2006
- This deviceK093480 Cuattro UnomdCuattro, LLC · 2010
- Descendant · cites it directly · 0 of its ownK161937 CuattroDRCuattro, LLC · 2016 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K161937CuattroDRCuattro, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900935 | DU Pont Linx Laser Imager W/the Linx Networking | E.I. Dupont DE Nemours & Co., Inc. | 1990 | — |
| −3 | K964250 | Linx Networking System | Sterling Diagnostic Imaging, Inc. | 1996 | — |
| −2 | K980970 | Iirad Directray Operator Console | Sterling Diagnostic Imaging, Inc. | 1998 | — |
| −1 | K063188 | Del-Ims | Del Medical Imaging Corp. | 2006 | — |
| 0 (this device) | K093480 | Cuattro Unomd | Cuattro, LLC | 2010 | — |
| +1 | K161937 | CuattroDR | Cuattro, LLC | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (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 |
|---|---|---|---|
| * | K063188 | Del-ImsSummary page 1…laimed to the following Legally Marketed Device: Manufacturer: Del Medical Imaging Device: DEL-IMS 510(k) number: K(063188 Page 13 of 539 Device Description The Cuattro UnoMD software is a Windows based software application capable of… | 2006 |
| † | K090742 | Digital Flat Panel X-Ray Detector, Model LTX240AA01-a | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161937 | CuattroDR | 2016 | 0 |
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 20 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K161937 (Cuattro, LLC, 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Cuattro UnoMD, when used with a cleared digital image capture device,
provides for the capture of digital images in place of conventional film radiographic
examinations.
The device is intended to be available for retrofit on existing or planned x-ray
machines with a cleared digital image capture device.
The device is intended for use by trained and qualified personnel in the acquisition
and review of radiographic images. The product is not intended for mammography
or fluoroscopy applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093480: Cuattro Unomd.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093480
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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