# K990066: CCD Camera, Model 9000

- Pathway: 510(k) (Traditional)
- Applicant: Camtronics, Ltd.
- Decided: Mar 17, 1999 after 68 days
- Product code: LMA (Digitizer, Image, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953974 (1996). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953974: Camvision 1000, Medivision Medical Imaging, Ltd. (1996) Summary page 1.

## Most influential descendants
- K162268: Senographe Pristina (2016), 3 descendants of its own
- K211725: Senographe Pristina (2021), 1 descendant of its own
- K260087: Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright (2026), 0 descendants of its own
- K163302: Senographe Pristina (2017), 0 descendants of its own

## Recalls of this device
- Jul 1, 2008 · Not classified · Z-2147-2008: 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 
- Jul 1, 2008 · Not classified · Z-2146-2008: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K990066
Methodology: https://510kreport.com/methodology