510(k) · Cleared
Recalled · 2009Philips Multidiagnost 4
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 Aug 19, 1996 after a 132-day review. The FDA summary names no predicate by number. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 19, 1996
- Review
- 132 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 3
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK961374 Philips Multidiagnost 4Philips Medical Systems, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK033486 GE Precision MpiNrt-Nordisk Rontgen Teknik A/S · 2003 · Recalled
- Descendant · cites it directly · 1 of its ownK023441 Philips Multidiagnost ElevaPhilips Medical Systems · 2002 · Recalled
- Descendant · 2 generations on · 0 of its ownK173631 Intelli-CNrt X-Ray A/S · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK050151 Multidiagnost ElevaPhilips Medical Systems North America, Inc. · 2005 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K033486GE Precision MpiNrt-Nordisk Rontgen Teknik A/S · 2003 · cites it directly1descendant
- K023441Philips Multidiagnost ElevaPhilips Medical Systems · 2002 · cites it directly1descendant
- K173631Intelli-CNrt X-Ray A/S · 2018 · 2 generations on0descendants
- K050151Multidiagnost ElevaPhilips Medical Systems North America, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961374 | Philips Multidiagnost 4 | Philips Medical Systems, Inc. | 1996 | — |
| +1 | K033486 | GE Precision Mpi | Nrt-Nordisk Rontgen Teknik A/S | 2003 | 7 |
| +1 | K023441 | Philips Multidiagnost Eleva | Philips Medical Systems | 2002 | 15 |
| +2 | K173631 | Intelli-C | Nrt X-Ray A/S | 2018 | 4 |
| +2 | K050151 | Multidiagnost Eleva | Philips Medical Systems North America, Inc. | 2005 | 21 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2018 | 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 18.2 · 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?
The FDA summary names no predicate by number.
What descends from it? (4)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 6, 2009 | Not classified | Z-1664-2009 | 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 |
| Apr 6, 2006 | Not classified | Z-0852-06 | Other | Potential for unexpected table movement. |
| Jan 10, 2003 | Not classified | Z-0586-03 | Other | INTERNAL SHORT CIRCUIT - MAY ALLOW FOR STAND AND TABLE TO MOVE SPONTANEOUSLY IN UPWARD OR DOWNWARD MOVEMENT |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033486 (Nrt-Nordisk Rontgen Teknik A/S, 2003) has gone furthest, with 1 descendant 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 MultiDIAGNOST 4 is indicated for use in Radiographic/Fluoroscopic, Angiographic, and Interventional diagnostic imaging examinations.
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/K961374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961374: Philips Multidiagnost 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961374
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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