510(k) · Cleared
ClearedRFX Fluroscopic Digital Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Vision, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on May 21, 2003 as substantially equivalent to K963037 (Infimed, Inc., 1996) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- May 21, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K963037 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK963037 PatriotInfimed, Inc. · 1996
- This deviceK030544 RFX Fluroscopic Digital Imaging SystemSigma Vision, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963037 | Patriot | Infimed, Inc. | 1996 | — |
| 0 (this device) | K030544 | RFX Fluroscopic Digital Imaging System | Sigma Vision, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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? (3)
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 |
|---|---|---|---|
| * | K963037 | PatriotSummary page 2…rawn from comparison: The RFX fluoroscopy digital imaging system can be considered to be substantially equivalent to: INFIMED Inc. GOLDONE Fluoroscopic System (510K) ~ K963037 CMT Medical Technologies. SPOT / RAD System (510K), K991578 and K003434 and, virtually all of the features offered by the predic… | 1996 |
| * | K991578 | Smartspot 2000Summary page 2…stem can be considered to be substantially equivalent to: INFIMED Inc. GOLDONE Fluoroscopic System (510K) ~ K963037 CMT Medical Technologies. SPOT / RAD System (510K), K991578 and K003434 and, virtually all of the features offered by the predicate devices are offered by the RFX product. 510(k) Number: U… | 1999 |
| * | K003434 | Allegro TB, Allegro NSummary page 2…considered to be substantially equivalent to: INFIMED Inc. GOLDONE Fluoroscopic System (510K) ~ K963037 CMT Medical Technologies. SPOT / RAD System (510K), K991578 and K003434 and, virtually all of the features offered by the predicate devices are offered by the RFX product. 510(k) Number: Unknown at th… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K963037.
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 RFX Fluoroscopic digital imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The RFX system allows the operator to view and enhance 1000 line fluoroscopy. High resolution digital spot images (1000 x…
Read the full statement (146 words)
The RFX Fluoroscopic digital imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.
The RFX system allows the operator to view and enhance 1000 line fluoroscopy. High resolution digital spot images (1000 x 1000) may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details that might be difficult or impossible to see using conventional imaging techniques. Images can be stored locally for medium term storage.
The RFX system enables the operator to print hardcopy images with a laser printer or send images over a network for longer term storage. The major system components include: a fluoroscopic CCD Camera, monitors, and an image processor
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/K030544 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030544: RFX Fluroscopic Digital Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030544
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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