510(k) · Cleared
Recalled · Class II · 2016Interventional Mobile Digital Imaging System (Herein Called Imdis)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Dec Medical Systems · OWB Interventional Fluoroscopic X-Ray System
Cleared on Feb 17, 1998 after a 90-day review. The FDA summary names its predicate without a number. 1 of the 44 devices in its family, counting itself, has a Class I recall. 43 later devices descend from it. It has been recalled once.
- Decided
- Feb 17, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 0
43 later devices descend from it, 2 citing it directly. 1 of the 44 devices in this family, counting this one, has a Class I recall.
- This deviceK974355 Interventional Mobile Digital Imaging System (Herein Called Imdis)Ge Dec Medical Systems · 1998
- Descendant · cites it directly · 39 of its ownK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- Descendant · 2 generations on · 35 of its ownK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- Descendant · 3 generations on · 27 of its ownK052480 Hansen Medical Catheter Control System (CCS) and Accessories, Hansen…Hansen Medical, Inc. · 2007 · Recalled
- Descendant · 4 generations on · 24 of its ownK073225 Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · Recalled
- Descendant · 5 generations on · 22 of its ownK090365 Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · Recalled
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K022069 Oec Fluorotrak 9800 Pluscites it directly · 2002
Most influential descendants
Showing 5 of 43 · See all- K013484Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System…Stereotaxis, Inc. · 2002 · cites it directly39descendants
- K021555Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003 · 2 generations on35descendants
- K052480Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable…Hansen Medical, Inc. · 2007 · 3 generations on27descendants
- K073225Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · 4 generations on24descendants
- K090365Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · 5 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974355 | Interventional Mobile Digital Imaging System (Herein Called Imdis) | Ge Dec Medical Systems | 1998 | — |
| +1 | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| +2 | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| +3 | K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical… | Hansen Medical, Inc. | 2007 | 2 |
| +4 | K073225 | Sensei Catheter Control System | Hansen Medical, Inc. | 2008 | 1 |
| +5 | K090365 | Hansen Medical Artisan S Control Catheter | Hansen Medical, Inc. | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 1 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | — | OEC Medical Systems - SERIES 9600® Mobile Digital Imaging System Named without a submission number | |
| * | — | Philips Medical Systems - BV 300 Series Mobile C-arm System Named without a submission number |
What descends from it? (43)
See all 432 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 22, 2016 | Class II | Z-2629-2016 | Software design (manufacturing process) | A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K022069Oec Fluorotrak 9800 PlusGe Oec Medical Systems · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K013484 (Stereotaxis, Inc., 2002) has gone furthest, with 39 descendants of its own.
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.
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 IMDIS is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician’s discretion.
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/K974355 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974355: Interventional Mobile Digital Imaging System (Herein Called Imdis).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974355
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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