510(k) · Cleared
ClearedI5 Digital X-Ray Imaging System (with Flaatz 560)
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 Jun 10, 2011 as substantially equivalent to K101833 (Infimed, Inc., 2010) after a 29-day review. Its family tree reaches back 6 generations to 1981.
- Decided
- Jun 10, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K803130 (1981). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 5 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 4 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 3 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 2 generations backK093066 I5 Digital X-Ray Imaging System, Model I5Infimed, Inc. · 2010
- 1 generation backK101833 Infistitch for I5 Digital X-Ray Imaging System, Model I5Infimed, Inc. · 2010
- This deviceK111344 I5 Digital X-Ray Imaging System (with Flaatz 560)Infimed, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −5 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −4 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −3 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −2 | K093066 | I5 Digital X-Ray Imaging System, Model I5 | Infimed, Inc. | 2010 | — |
| −1 | K101833 | Infistitch for I5 Digital X-Ray Imaging System, Model I5 | Infimed, Inc. | 2010 | — |
| 0 (this device) | K111344 | I5 Digital X-Ray Imaging System (with Flaatz 560) | Infimed, Inc. | 2011 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K101833 | Infistitch for I5 Digital X-Ray Imaging System, Model I5Summary page 1…ct Codes: STM Nl o . 1"™ Digital X-ray Imaging System (with FLAATZ 560 2 g ging Sy ) OWB, SR, 121 Predicate Device: 510(k) Number: Product Codes: InfiStitch for i’'™ K101833 MQB Device Description: The InfiMed i*™ Digital X-ray Imaging System is a high resolution digital imaging system designed for d… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 18 ancestors have a recall of any class.
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. 2011, 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 (183 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/K111344 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111344: I5 Digital X-Ray Imaging System (with Flaatz 560).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111344
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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