PMA · Approved
ApprovedRapidscreen RS-2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riverain Medical Group · MYN Analyzer, Medical Image
Approved on Jul 12, 2001 through premarket approval, which rests on the device’s own clinical evidence after a 275-day review. 13 later devices descend from it.
- Decided
- Jul 12, 2001
- Review
- 275 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
13 later devices descend from it, 2 citing it directly.
- This deviceP000041 Rapidscreen RS-2000Riverain Medical Group · 2001
- Descendant · cites it directly · 8 of its ownK210666 Chest-CADImagen Technologies, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK201560 Auto Lung Nodule DetectionSamsung Electronics Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK213353 Aorta-CADImagen Technologies, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK241620 ChestView USGleamer Sas · 2025
- Descendant · 2 generations on · 1 of its ownK230085 Lung-CADImagen Technologies, Inc. · 2023
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K210666Chest-CADImagen Technologies, Inc. · 2021 · cites it directly8descendants
- K201560Auto Lung Nodule DetectionSamsung Electronics Co., Ltd. · 2021 · cites it directly3descendants
- K213353Aorta-CADImagen Technologies, Inc. · 2022 · 2 generations on2descendants
- K241620ChestView USGleamer Sas · 2025 · 3 generations on1descendant
- K230085Lung-CADImagen Technologies, Inc. · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P000041 | Rapidscreen RS-2000 | Riverain Medical Group | 2001 | — |
| +1 | K210666 | Chest-CAD | Imagen Technologies, Inc. | 2021 | — |
| +1 | K201560 | Auto Lung Nodule Detection | Samsung Electronics Co., Ltd. | 2021 | — |
| +2 | K213353 | Aorta-CAD | Imagen Technologies, Inc. | 2022 | — |
| +3 | K241620 | ChestView US | Gleamer Sas | 2025 | — |
| +2 | K230085 | Lung-CAD | Imagen Technologies, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MYN? 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 MYN device
- #1 K210365 Second Opinionscore 29.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K210666 (Imagen Technologies, Inc., 2021) has gone furthest, with 8 descendants of its own.
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MYN
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYN
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MYN
No recall names MYN since 2007.
Adverse event reports per year · MYN
2in 2025
MAUDE reports naming product code MYN, 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 | 5 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 6 | — | 0 | 0 |
| 2013 | 4 | — | 0 | 0 |
| 2014 | 3 | — | 0 | 0 |
| 2015 | 3 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 5 | 273 | 0 | 0 |
| 2023 | 10 | 229 | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 14 | 210 | 0 | 2 |
| 2026 | 7 | 128 | 0 | — |
https://510kreport.com/device/P000041 · printed Nov 6, 2026
Cite this page
510(k) Report. “P000041: Rapidscreen RS-2000.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P000041
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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