510(k) · Cleared
Recalled · Class II · 2012Philips Easy Diagnost
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America, Inc. · IXR Table, Radiographic, Tilting
Cleared on Mar 21, 1997 as substantially equivalent to K924593 (Philips Medical Systems, Inc., 1992) after a 29-day review. Its family tree reaches back 1 generation to 1992. 7 later devices descend from it. It has been recalled 5 times.
- Decided
- Mar 21, 1997
- Review
- 29 days
- Class
- Class II
- Product code
- IXR
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924593 (1992). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK924593 Diagnost 76 Family*R/F Systems - Release 4.4Philips Medical Systems, Inc. · 1992 · Recalled
- This deviceK970640 Philips Easy DiagnostPhilips Medical Systems North America, Inc. · 1997
- Descendant · cites it directly · 6 of its ownK031535 Philips Easydiagnost ElevaPhilips Medical Systems North America Co. · 2003 · Recalled
- Descendant · 2 generations on · 2 of its ownK173433 ProxiDiagnost N90Philips Medical Systems Dmc GmbH · 2018 · Recalled
- Descendant · 2 generations on · 2 of its ownK163210 Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2017 · Recalled
- Descendant · 3 generations on · 1 of its ownK212837 ProxiDiagnost N90Philips Medical Systems Dmc GmbH · 2021 · Recalled
- Descendant · 3 generations on · 1 of its ownK203087 CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2020 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K031535Philips Easydiagnost ElevaPhilips Medical Systems North America Co. · 2003 · cites it directly6descendants
- K173433ProxiDiagnost N90Philips Medical Systems Dmc GmbH · 2018 · 2 generations on2descendants
- K163210Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2017 · 2 generations on2descendants
- K212837ProxiDiagnost N90Philips Medical Systems Dmc GmbH · 2021 · 3 generations on1descendant
- K203087CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924593 | Diagnost 76 Family*R/F Systems - Release 4.4 | Philips Medical Systems, Inc. | 1992 | 1 |
| 0 (this device) | K970640 | Philips Easy Diagnost | Philips Medical Systems North America, Inc. | 1997 | — |
| +1 | K031535 | Philips Easydiagnost Eleva | Philips Medical Systems North America Co. | 2003 | 15 |
| +2 | K173433 | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | 2018 | 7 |
| +2 | K163210 | Philips CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2017 | 8 |
| +3 | K212837 | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | 2021 | 5 |
| +3 | K203087 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2020 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 IXR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K924593 | Diagnost 76 Family*R/F Systems - Release 4.4Summary page 2…tially equivalent to, the Philips DIAGNOST 76 plus manufactured by Philips Medical Systems. The DIAGNOST 76 plus received 510(k) clearance November 24, 1992 ( see 510(k) K924593). The DIAGNOST 76 plus was found substantially equivalent to the DIAGNOST 73, which is a pre-amendment device. The intended use o… | 1992 |
| * | — | Diagnost 73 Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031535 | Philips Easydiagnost Eleva | 2003 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 11, 2012 | Class II | Z-2208-2012 | Equipment maintenance | Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors. |
| May 11, 2012 | Class II | Z-1821-2012 | Device Design | If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to… |
| Jan 21, 2010 | Not classified | Z-0849-2010 | Radiation Control for Health and Safety Act | Device failed to display appropriate labels indicating Radiation Symbol along with the required wording. |
| Jan 4, 2008 | Not classified | Z-2405-2010 | Other | Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path. |
| Jul 23, 2007 | Not classified | Z-0909-2007 | Other | Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K031535 (Philips Medical Systems North America Co., 2003) has gone furthest, with 6 descendants of its own.
How does its category compare?
All IXR devicesIXR Table, Radiographic, Tilting: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXR
FDA has decided no IXR device since 2007.
Median 510(k) review, days · IXR
Too few IXR 510(k)s in any year since 2007 to give a median.
Recalls per year · IXR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IXR
1in 2024
MAUDE reports naming product code IXR, 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 | 0 | — | 1 | 4 |
| 2008 | 0 | — | 4 | 8 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 5 | 12 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 164 |
| 2013 | 0 | — | 0 | 196 |
| 2014 | 0 | — | 0 | 120 |
| 2015 | 0 | — | 0 | 82 |
| 2016 | 0 | — | 1 | 58 |
| 2017 | 0 | — | 1 | 25 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 1 | 8 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K970640 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970640: Philips Easy Diagnost.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970640
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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