510(k) · Cleared
ClearedRfvision, Model 9.9D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Almana Medical Imaging · OWB Interventional Fluoroscopic X-Ray System
Cleared on Aug 6, 2008 as substantially equivalent to K061173 (Communications & Power Industries Canada, Inc., 2006) after a 133-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Aug 6, 2008
- Review
- 133 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K911454 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK911454 FC2000S & S Inficon, Inc. · 1991
- 2 generations backK012490 Orion Digital Imaging SystemInfimed, Inc. · 2002
- 1 generation backK061173 Cpivision Digital Imaging SystemCommunications & Power Industries Canada, Inc. · 2006
- This deviceK080847 Rfvision, Model 9.9DAlmana Medical Imaging · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911454 | FC2000 | S & S Inficon, Inc. | 1991 | — |
| −2 | K012490 | Orion Digital Imaging System | Infimed, Inc. | 2002 | — |
| −1 | K061173 | Cpivision Digital Imaging System | Communications & Power Industries Canada, Inc. | 2006 | — |
| 0 (this device) | K080847 | Rfvision, Model 9.9D | Almana Medical Imaging | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (1)
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 |
|---|---|---|---|
| * | K061173 | Cpivision Digital Imaging SystemSummary page 2…esling indicates that the new device is as safe and effective as the predicate devices. ’ Page 5 of 47 6. Substantial Equivalence Chart Characteristic K061173, Device Name: CPIVision Digital Imaging System, Communications & Power Industries Canada, Inc. Almana RFVision 9.9D Image Intens… | 2006 |
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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 4 ancestors has a recall.
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. 2008, this device’s year, is highlighted.
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 RFVision 9.9D is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.
The RFVision 9.9D allows the operator to view and enhance digital fluoroscopic images. High resolution digital spot images may be acquired at single or rapid acquisition rates. images may be viewed and enhanced enabling the operator to bring out diagnostic details.
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/K080847 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080847: Rfvision, Model 9.9D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080847
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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