510(k) · Cleared
Recalled · Class II · 2019Philips Omnidiagnost
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Sep 29, 1998 as substantially equivalent to K912470 (Philips Medical Systems, Inc., 1991) after a 33-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 29, 1998
- Review
- 33 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912470 (1991). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- This deviceK982993 Philips OmnidiagnostPhilips Medical Systems, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK032046 Phillips Omnidiagnost ElevaPhilips Medical Systems, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK092713 Spectre Wireless Encrypted Footswitch and Hand Switch SystemTransamerican Medical Imaging · 2010 · Recalled
- Descendant · 2 generations on · 0 of its ownK050692 FLXISPhilips Medical Systems North America Co. · 2005
Most influential descendants
Showing 3 of 3 · See all- K032046Phillips Omnidiagnost ElevaPhilips Medical Systems, Inc. · 2003 · cites it directly2descendants
- K092713Spectre Wireless Encrypted Footswitch and Hand Switch SystemTransamerican Medical Imaging · 2010 · 2 generations on0descendants
- K050692FLXISPhilips Medical Systems North America Co. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912470 | Philips Diagnost 96 | Philips Medical Systems, Inc. | 1991 | 9 |
| 0 (this device) | K982993 | Philips Omnidiagnost | Philips Medical Systems, Inc. | 1998 | — |
| +1 | K032046 | Phillips Omnidiagnost Eleva | Philips Medical Systems, Inc. | 2003 | 8 |
| +2 | K092713 | Spectre Wireless Encrypted Footswitch and Hand Switch System | Transamerican Medical Imaging | 2010 | 1 |
| +2 | K050692 | FLXIS | Philips Medical Systems North America Co. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K912470 | Philips Diagnost 96Summary page 1…uced under K920950). Substantial equivalence Information The OmniDiagnost is a modification of, and substantially equivalent to the Philips Diagnost 96 system (FDA ref. K912470). Safety Information The Philips OmniDiagnost complies with the applicable portions of 21 CFR parts 1020.30/.31/.32 and voluntar… | 1991 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032046 | Phillips Omnidiagnost Eleva | 2003 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2019 | Class II | Z-1054-2019 | Component design/selection | The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user. |
| May 1, 2018 | Class II | Z-2301-2018 | Device Design | The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating movement can not be stopped by the user. This… |
| Jul 6, 2009 | Not classified | Z-1665-2009 | Radiation Control for Health and Safety Act | The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch |
| Jul 17, 2003 | Not classified | Z-0874-03 | Other | Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Philips OmniDiagnost is a diagnostic imaging device intended for radiographic,
fluoroscopic, angiographic, and interventional applications.
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/K982993 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982993: Philips Omnidiagnost.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982993
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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