510(k) · Cleared
ClearedLinx Networking System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterling Diagnostic Imaging, Inc. · LMD System, Digital Image Communications, Radiological
Cleared on Dec 18, 1996 as substantially equivalent to K900935 (E.I. Dupont DE Nemours & Co., Inc., 1990) after a 55-day review. Its family tree reaches back 1 generation to 1990. 9 later devices descend from it.
- Decided
- Dec 18, 1996
- Review
- 55 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900935 (1990). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK900935 DU Pont Linx Laser Imager W/the Linx NetworkingE.I. Dupont DE Nemours & Co., Inc. · 1990
- This deviceK964250 Linx Networking SystemSterling Diagnostic Imaging, Inc. · 1996
- Descendant · cites it directly · 8 of its ownK980970 Iirad Directray Operator ConsoleSterling Diagnostic Imaging, Inc. · 1998
- Descendant · 2 generations on · 3 of its ownK033345 AN5150 and AN7150 Digital Radiology SystemsAnalogic Corp. · 2003
- Descendant · 2 generations on · 2 of its ownK063188 Del-ImsDel Medical Imaging Corp. · 2006
- Descendant · 3 generations on · 2 of its ownK040995 Synerad Multi Digital X-Ray System, Model AN6150Analogic Corp. · 2004 · Recalled
- Descendant · 3 generations on · 1 of its ownK093480 Cuattro UnomdCuattro, LLC · 2010
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K980970Iirad Directray Operator ConsoleSterling Diagnostic Imaging, Inc. · 1998 · cites it directly8descendants
- K033345AN5150 and AN7150 Digital Radiology SystemsAnalogic Corp. · 2003 · 2 generations on3descendants
- K063188Del-ImsDel Medical Imaging Corp. · 2006 · 2 generations on2descendants
- K040995Synerad Multi Digital X-Ray System, Model AN6150Analogic Corp. · 2004 · 3 generations on2descendants
- K093480Cuattro UnomdCuattro, LLC · 2010 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900935 | DU Pont Linx Laser Imager W/the Linx Networking | E.I. Dupont DE Nemours & Co., Inc. | 1990 | — |
| 0 (this device) | K964250 | Linx Networking System | Sterling Diagnostic Imaging, Inc. | 1996 | — |
| +1 | K980970 | Iirad Directray Operator Console | Sterling Diagnostic Imaging, Inc. | 1998 | — |
| +2 | K033345 | AN5150 and AN7150 Digital Radiology Systems | Analogic Corp. | 2003 | — |
| +2 | K063188 | Del-Ims | Del Medical Imaging Corp. | 2006 | — |
| +3 | K040995 | Synerad Multi Digital X-Ray System, Model AN6150 | Analogic Corp. | 2004 | 1 |
| +3 | K093480 | Cuattro Unomd | Cuattro, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 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 LMD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K900935 | DU Pont Linx Laser Imager W/the Linx NetworkingSummary page 1…600/Mailbox 630 Newark, DE 19714-6101 Fax # (302) 451-0386 DEVICE NAME: LINX™ Networking System PREDICATE DEVICE: LINX™ Networking System with LINX™ Laser Imager (K900935) DEVICE DESCRIPTION AND INTENDED USE: This Premarket Notification 510(k) is being filed to cover additions to the LINX™ Network… | 1990 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K980970 (Sterling Diagnostic Imaging, Inc., 1998) has gone furthest, with 8 descendants of its own.
How does its category compare?
All LMD devicesLMD System, Digital Image Communications, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMD
FDA has decided no LMD device since 2007.
Median 510(k) review, days · LMD
Too few LMD 510(k)s in any year since 2007 to give a median.
Recalls per year · LMD
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMD
16in 2025
MAUDE reports naming product code LMD, 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 | 0 | — | 2 | 1 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 1 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 2 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The basic product concept remains - to connect various image input devices to one or more output devices.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964250: Linx Networking System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964250
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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