510(k) · Cleared
Recalled · 2008CCD Camera, Model 9000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camtronics, Ltd. · LMA Digitizer, Image, Radiological
Cleared on Mar 17, 1999 as substantially equivalent to K953974 (Medivision Medical Imaging, Ltd., 1996) after a 68-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 17, 1999
- Review
- 68 days
- Class
- Class II
- Product code
- LMA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953974 (1996). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK953974 Camvision 1000Medivision Medical Imaging, Ltd. · 1996
- This deviceK990066 CCD Camera, Model 9000Camtronics, Ltd. · 1999
- Descendant · cites it directly · 3 of its ownK162268 Senographe PristinaGE Healthcare · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK211725 Senographe PristinaGE Healthcare · 2021
- Descendant · 3 generations on · 0 of its ownK260087 Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena…GE Medical Systems SCS · 2026
- Descendant · 2 generations on · 0 of its ownK163302 Senographe PristinaGE Healthcare · 2017
Most influential descendants
Showing 4 of 4 · See all- K162268Senographe PristinaGE Healthcare · 2016 · cites it directly3descendants
- K211725Senographe PristinaGE Healthcare · 2021 · 2 generations on1descendant
- K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCS · 2026 · 3 generations on0descendants
- K163302Senographe PristinaGE Healthcare · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953974 | Camvision 1000 | Medivision Medical Imaging, Ltd. | 1996 | — |
| 0 (this device) | K990066 | CCD Camera, Model 9000 | Camtronics, Ltd. | 1999 | — |
| +1 | K162268 | Senographe Pristina | GE Healthcare | 2016 | 3 |
| +2 | K211725 | Senographe Pristina | GE Healthcare | 2021 | — |
| +3 | K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | GE Medical Systems SCS | 2026 | — |
| +2 | K163302 | Senographe Pristina | GE Healthcare | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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 LMA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K953974 | Camvision 1000Summary page 1…ce trade name: CCD Camera Common name: CCD Video Camera Classification name: System, X-ray, Fluoroscopic, Image-intensified Predicate substantially equivalent devices: K953974 MediVision-Medical Imaging Ltd. “Camvision 1000” WK Go0 066 Device description and intended use: This device is a Charge Couple… | 1996 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162268 | Senographe Pristina | 2016 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 1, 2008 | Not classified | Z-2147-2008 | Radiation Control for Health and Safety Act | GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a specific angulated view associated with use of the Stereotactic Positioner of your… |
| Jul 1, 2008 | Not classified | Z-2146-2008 | Radiation Control for Health and Safety Act | GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a specific angulated view associated with use of the Stereotactic Positioner of your… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K162268 (GE Healthcare, 2016) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LMA devicesLMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMA
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · LMA
80in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMA
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMA
1in 2013
MAUDE reports naming product code LMA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 3 | 80 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is a Charge Coupled Device (CCD) video camera for use in digital radiography, including DSA, high resolution cardiology, and low dose fluoroscopy. It is designed for use with X-ray image intensifiers in diagnostic imaging chains.
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/K990066 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990066: CCD Camera, Model 9000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990066
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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