510(k) · Cleared
ClearedHitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System (SX-VA30)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Feb 26, 1997 as substantially equivalent to K945400 (Hitachi Medical Corp. of America, 1995) and 1 other predicate after a 72-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Feb 26, 1997
- Review
- 72 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923813 (1992). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK923813 Philips Integris V3000 Rotational Angio FunctionPhilips Medical Systems, Inc. · 1992 · Recalled
- This deviceK964990 Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System (SX-VA30)Hitachi Medical Systems America, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK991231 Hitachi VersiflexHitachi Medical Systems America, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K991231Hitachi VersiflexHitachi Medical Systems America, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923813 | Philips Integris V3000 Rotational Angio Function | Philips Medical Systems, Inc. | 1992 | 1 |
| 0 (this device) | K964990 | Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System (SX-VA30) | Hitachi Medical Systems America, Inc. | 1997 | — |
| +1 | K991231 | Hitachi Versiflex | Hitachi Medical Systems America, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 JAA? 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 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? (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 |
|---|---|---|---|
| * | K945400 | Hitachi Dynamic 3D Imaging System,SF-VA100Summary page 1…Angiographic/Fluoroscopic System is substantially equivalent to the presently marketed Hitachi SF-VA100 as distributed by Hitachi Medical Systems America (as cleared in K945400) and the Philips Medical Systems Integris V3000 (KS23813). The SX- VA30is manufactured by Hitachi Medical Corporation, Hitachi Ha… | 1995 |
| * | K923813 | Philips Integris V3000 Rotational Angio Function Our OCR of the scanned summary read K523813, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Philips Medical Systems Integris V3000”. | 1992 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991231 | Hitachi Versiflex | 1999 | 0 |
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K991231 (Hitachi Medical Systems America, Inc., 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.
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/K964990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964990: Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System (SX-VA30).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964990
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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