510(k) · Cleared
ClearedDel-Ims
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Del Medical Imaging Corp. · LLZ System, Image Processing, Radiological
Cleared on Nov 30, 2006 as substantially equivalent to K980970 (Sterling Diagnostic Imaging, Inc., 1998) after a 41-day review. Its family tree reaches back 3 generations to 1990. 2 later devices descend from it.
- Decided
- Nov 30, 2006
- Review
- 41 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K900935 (1990). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK900935 DU Pont Linx Laser Imager W/the Linx NetworkingE.I. Dupont DE Nemours & Co., Inc. · 1990
- 2 generations backK964250 Linx Networking SystemSterling Diagnostic Imaging, Inc. · 1996
- 1 generation backK980970 Iirad Directray Operator ConsoleSterling Diagnostic Imaging, Inc. · 1998
- This deviceK063188 Del-ImsDel Medical Imaging Corp. · 2006
- Descendant · cites it directly · 1 of its ownK093480 Cuattro UnomdCuattro, LLC · 2010
- Descendant · 2 generations on · 0 of its ownK161937 CuattroDRCuattro, LLC · 2016 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900935 | DU Pont Linx Laser Imager W/the Linx Networking | E.I. Dupont DE Nemours & Co., Inc. | 1990 | — |
| −2 | K964250 | Linx Networking System | Sterling Diagnostic Imaging, Inc. | 1996 | — |
| −1 | K980970 | Iirad Directray Operator Console | Sterling Diagnostic Imaging, Inc. | 1998 | — |
| 0 (this device) | K063188 | Del-Ims | Del Medical Imaging Corp. | 2006 | — |
| +1 | K093480 | Cuattro Unomd | Cuattro, LLC | 2010 | — |
| +2 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K980970 | Iirad Directray Operator ConsoleSummary page 1…Stationary Digital X-Ray Systems Cl.assification Name: 892.2050 Picture Archiving and Communications Device Predicate Device: Sterling DROC, (K980970). Product Description: The DEU-MS is intended to provide a network connection via DICOM protocol to various output… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093480 | Cuattro Unomd | 2010 | 1 |
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 16 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K093480 (Cuattro, LLC, 2010) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K980970.
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?
The DEL-IMS has application wherever the transmission of radiographic images and associated patient text data is desired to take place from an input, such as radiographic equipment which employs a digital image capture device, to an output device such as hardcopy, softcopy, or archive device.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063188 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063188: Del-Ims.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063188
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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