510(k) · Cleared
ClearedI5 Digital X-Ray Imaging System, Model I5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infimed, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Mar 16, 2010 as substantially equivalent to K012490 (Infimed, Inc., 2002) and 1 other predicate after a 167-day review. Its family tree reaches back 4 generations to 1981. 22 later devices descend from it.
- Decided
- Mar 16, 2010
- Review
- 167 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K803130 (1981). 16 ancestors in all. 22 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 3 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 2 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 1 generation backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- This deviceK093066 I5 Digital X-Ray Imaging System, Model I5Infimed, Inc. · 2010
- Descendant · cites it directly · 17 of its ownK103416 Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc. · 2011
- Descendant · 2 generations on · 15 of its ownK130318 Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Varian Medical Systems, X-Ray Products-Infimed · 2013
- Descendant · cites it directly · 6 of its ownK162529 DigiX FDXAllengers Medical Systems Limited · 2017
- Descendant · 2 generations on · 5 of its ownK192541 DigiX FDXAllengers Medical Systems Limited · 2019
- Descendant · 3 generations on · 5 of its ownK161459 Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)Varian Medical Systems, X-Ray Products-Infimed · 2016
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K103416Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc. · 2011 · cites it directly17descendants
- K130318Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Varian Medical Systems, X-Ray Products-Infimed · 2013 · 2 generations on15descendants
- K162529DigiX FDXAllengers Medical Systems Limited · 2017 · cites it directly6descendants
- K192541DigiX FDXAllengers Medical Systems Limited · 2019 · 2 generations on5descendants
- K161459Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)Varian Medical Systems, X-Ray Products-Infimed · 2016 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −3 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −2 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −1 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| 0 (this device) | K093066 | I5 Digital X-Ray Imaging System, Model I5 | Infimed, Inc. | 2010 | — |
| +1 | K103416 | Nexus DRF Digital X-Ray Imaging System | Infimed, Inc. | 2011 | — |
| +2 | K130318 | Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB) | Varian Medical Systems, X-Ray Products-Infimed | 2013 | — |
| +1 | K162529 | DigiX FDX | Allengers Medical Systems Limited | 2017 | — |
| +2 | K192541 | DigiX FDX | Allengers Medical Systems Limited | 2019 | — |
| +3 | K161459 | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) | Varian Medical Systems, X-Ray Products-Infimed | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K012490 | Orion Digital Imaging SystemSummary page 1…ensified fluoroscopic X-ray system JAA , OWE Solid State X-ray Imaging Device MQB, TZ1 Predicate Devices: 510(k) Number: Product Codes: Orion Fluoroscopic Imaging System K012490 JAA StingRay DR K992794 MQB Device Description: The InfiMed i°* ™ Digital X-ray Imaging System is a high resolution digital im… | 2002 |
| * | K992794 | Stingray DR, Model 1Summary page 1…ay system JAA , OWE Solid State X-ray Imaging Device MQB, TZ1 Predicate Devices: 510(k) Number: Product Codes: Orion Fluoroscopic Imaging System K012490 JAA StingRay DR K992794 MQB Device Description: The InfiMed i°* ™ Digital X-ray Imaging System is a high resolution digital imaging system desifined for… | 1999 |
What descends from it? (22)
See all 225 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 29 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 8 of the 16 ancestors have a recall of any class.
- Of its descendants, K103416 (Infimed, Inc., 2011) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K012490.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The InfiMed i* ™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i* ™ Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image…
Read the full statement (188 words)
The InfiMed i* ™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i* ™ Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i* ™ Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.
For the DR application, the InfiMed i* ™ Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).
For the RF/DSA application, the InfiMed i* ™ Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.
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/K093066 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093066: I5 Digital X-Ray Imaging System, Model I5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093066
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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