510(k) · Cleared
ClearedCamvision 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medivision Medical Imaging, Ltd. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Sep 9, 1996 after a 383-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Sep 9, 1996
- Review
- 383 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK953974 Camvision 1000Medivision Medical Imaging, Ltd. · 1996
- Descendant · cites it directly · 4 of its ownK990066 CCD Camera, Model 9000Camtronics, Ltd. · 1999 · Recalled
- Descendant · 2 generations on · 3 of its ownK162268 Senographe PristinaGE Healthcare · 2016 · Recalled
- Descendant · 3 generations on · 1 of its ownK211725 Senographe PristinaGE Healthcare · 2021
- Descendant · 4 generations on · 0 of its ownK260087 Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena…GE Medical Systems SCS · 2026
- Descendant · 3 generations on · 0 of its ownK163302 Senographe PristinaGE Healthcare · 2017
Most influential descendants
Showing 5 of 5 · See all- K990066CCD Camera, Model 9000Camtronics, Ltd. · 1999 · cites it directly4descendants
- K162268Senographe PristinaGE Healthcare · 2016 · 2 generations on3descendants
- K211725Senographe PristinaGE Healthcare · 2021 · 3 generations on1descendant
- K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCS · 2026 · 4 generations on0descendants
- K163302Senographe PristinaGE Healthcare · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953974 | Camvision 1000 | Medivision Medical Imaging, Ltd. | 1996 | — |
| +1 | K990066 | CCD Camera, Model 9000 | Camtronics, Ltd. | 1999 | 2 |
| +2 | K162268 | Senographe Pristina | GE Healthcare | 2016 | 3 |
| +3 | K211725 | Senographe Pristina | GE Healthcare | 2021 | — |
| +4 | K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | GE Medical Systems SCS | 2026 | — |
| +3 | K163302 | Senographe Pristina | GE Healthcare | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990066 | CCD Camera, Model 9000 | 1999 | 4 |
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, K990066 (Camtronics, Ltd., 1999) has gone furthest, with 4 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 | — |
https://510kreport.com/device/K953974 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953974: Camvision 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953974
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026