510(k) · Cleared
ClearedDG 200/300 Digital Angiographic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thomson-Cgr Medical Corp. · IXI Block, Beam-Shaping, Radiation Therapy
Cleared on Aug 7, 1985 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 66 later devices descend from it.
- Decided
- Aug 7, 1985
- Review
- 65 days
- Class
- Class II
- Product code
- IXI
- Recalls
- None
- Predicates
- 0
66 later devices descend from it, 1 citing it directly.
- This deviceK852353 DG 200/300 Digital Angiographic SystemThomson-Cgr Medical Corp. · 1985
- Descendant · cites it directly · 65 of its ownK092639 Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT…GE Medical Systems SCS · 2009
- Descendant · 2 generations on · 41 of its ownK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
- Descendant · 3 generations on · 39 of its ownK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
- Descendant · 4 generations on · 32 of its ownK121781 Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012
- Descendant · 5 generations on · 28 of its ownK172607 Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic…Philips Health Care · 2017 · Recalled
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K092639Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision…GE Medical Systems SCS · 2009 · cites it directly65descendants
- K101311EP Navigator R3Philips Medical Systems North America Co. · 2010 · 2 generations on41descendants
- K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011 · 3 generations on39descendants
- K121781Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012 · 4 generations on32descendants
- K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care · 2017 · 5 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K852353 | DG 200/300 Digital Angiographic System | Thomson-Cgr Medical Corp. | 1985 | — |
| +1 | K092639 | Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova… | GE Medical Systems SCS | 2009 | — |
| +2 | K101311 | EP Navigator R3 | Philips Medical Systems North America Co. | 2010 | — |
| +3 | K111245 | Heartnavigator Release 1 | Philips Medical Systems Nederland B.V. | 2011 | — |
| +4 | K121781 | Echonavigator Release 1 | Philips Medical Systems Nederland B.V. | 2012 | — |
| +5 | K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound… | Philips Health Care | 2017 | 31 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 9 | 0 |
| 2026 | 9 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IXI? 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 IXI device
- #1 K253025 Ricoh 3D for Healthcare Bolusscore 12.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (66)
See all 661 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092639 | Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision… | 2009 | 65 |
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?
- Of its descendants, K092639 (GE Medical Systems SCS, 2009) has gone furthest, with 65 descendants of its own.
How does its category compare?
All IXI devicesIXI Block, Beam-Shaping, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXI
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · IXI
90in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IXI
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IXI
1in 2016
MAUDE reports naming product code IXI, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 3 | 78 | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 2 | — | 1 | 28 |
| 2012 | 1 | — | 1 | 3 |
| 2013 | 3 | 90 | 2 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K852353 · printed Nov 4, 2026
Cite this page
510(k) Report. “K852353: DG 200/300 Digital Angiographic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K852353
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026