510(k) · Cleared
ClearedIirad Directray Operator Console
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterling Diagnostic Imaging, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jun 8, 1998 as substantially equivalent to K973206 (Sterling Diagnostic Imaging, Inc., 1997) and 2 other predicates after an 84-day review. Its family tree reaches back 2 generations to 1990. 8 later devices descend from it.
- Decided
- Jun 8, 1998
- Review
- 84 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K900935 (1990). 4 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK900935 DU Pont Linx Laser Imager W/the Linx NetworkingE.I. Dupont DE Nemours & Co., Inc. · 1990
- 1 generation backK964250 Linx Networking SystemSterling Diagnostic Imaging, Inc. · 1996
- This deviceK980970 Iirad Directray Operator ConsoleSterling Diagnostic Imaging, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK033345 AN5150 and AN7150 Digital Radiology SystemsAnalogic Corp. · 2003
- Descendant · cites it directly · 2 of its ownK063188 Del-ImsDel Medical Imaging Corp. · 2006
- Descendant · 2 generations on · 2 of its ownK040995 Synerad Multi Digital X-Ray System, Model AN6150Analogic Corp. · 2004 · Recalled
- Descendant · 2 generations on · 1 of its ownK093480 Cuattro UnomdCuattro, LLC · 2010
- Descendant · 3 generations on · 1 of its ownK043025 Synerad Omni, Digital X-Ray System, Model AN6250Analogic Corp. · 2004
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K033345AN5150 and AN7150 Digital Radiology SystemsAnalogic Corp. · 2003 · cites it directly3descendants
- K063188Del-ImsDel Medical Imaging Corp. · 2006 · cites it directly2descendants
- K040995Synerad Multi Digital X-Ray System, Model AN6150Analogic Corp. · 2004 · 2 generations on2descendants
- K093480Cuattro UnomdCuattro, LLC · 2010 · 2 generations on1descendant
- K043025Synerad Omni, Digital X-Ray System, Model AN6250Analogic Corp. · 2004 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900935 | DU Pont Linx Laser Imager W/the Linx Networking | E.I. Dupont DE Nemours & Co., Inc. | 1990 | — |
| −1 | K964250 | Linx Networking System | Sterling Diagnostic Imaging, Inc. | 1996 | — |
| 0 (this device) | K980970 | Iirad Directray Operator Console | Sterling Diagnostic Imaging, Inc. | 1998 | — |
| +1 | K033345 | AN5150 and AN7150 Digital Radiology Systems | Analogic Corp. | 2003 | — |
| +1 | K063188 | Del-Ims | Del Medical Imaging Corp. | 2006 | — |
| +2 | K040995 | Synerad Multi Digital X-Ray System, Model AN6150 | Analogic Corp. | 2004 | 1 |
| +2 | K093480 | Cuattro Unomd | Cuattro, LLC | 2010 | — |
| +3 | K043025 | Synerad Omni, Digital X-Ray System, Model AN6250 | Analogic Corp. | 2004 | — |
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 |
|---|---|---|
| 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 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? (3)
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 |
|---|---|---|---|
| * | K973206 | Sterling Diagnostic Imaging Direct RadiographySummary page 1…: Unclassified - Solid-State Digital X-Ray Device(30MQB) PREDICATE DEVICES: In both versions, the DROC is an accessory to the DirectRay™ digital image capture device (K#973206). Parallel: LINX™ Networking System - K964250 Integrated: MicroX-80 HF - K944149 (X-ray console functions only) Sterling Diagn… | 1997 |
| * | K964250 | Linx Networking SystemSummary page 1…ice(30MQB) PREDICATE DEVICES: In both versions, the DROC is an accessory to the DirectRay™ digital image capture device (K#973206). Parallel: LINX™ Networking System - K964250 Integrated: MicroX-80 HF - K944149 (X-ray console functions only) Sterling Diagnostic Imaging, 1ne. 10 South Academy Street PO… | 1996 |
| * | K944149 | Micro X-80 HFSummary page 1…th versions, the DROC is an accessory to the DirectRay™ digital image capture device (K#973206). Parallel: LINX™ Networking System - K964250 Integrated: MicroX-80 HF - K944149 (X-ray console functions only) Sterling Diagnostic Imaging, 1ne. 10 South Academy Street PO, Box 1975y Greenville, SC 29602-903… | 1994 |
What descends from it? (8)
3 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K033345 (Analogic Corp., 2003) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K973206.
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 DirectRay™ Operator Console has application whenever the transmission of radiographic images and associated patient text data is desired to take place from an input device, such as any radiographic equipment which uses the DirectRay™ device, to any output device, such as hardcopy, softcopy, or archive 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/K980970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980970: Iirad Directray Operator Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980970
Report an extraction error
Are you the manufacturer?
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