# K031825: C.CAM

- Pathway: 510(k) (Abbreviated)
- Applicant: Danish Diagnostic Development A/S
- Decided: Jun 20, 2003 after 7 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- 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 K001888 (2000). 2 ancestors in all.
98 later devices descend from it; 3 cite it directly.
6 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011611: Cardiocam Model 9CSY0799, Danish Diagnostic Development A/S (2001)
- K001888: Unicorn Model SYS0630, Danish Diagnostic Development A/S (2000) Summary page 1.

## Most influential descendants
- K072567: Symbia-E, Model 10275879 (2007), 85 descendants of its own
- K082506: Symbia, Version 4.0 (2008), 83 descendants of its own
- K131634: Symbia (2013), 66 descendants of its own
- K142006: Symbia 6.0 (2014), 65 descendants of its own
- K162483: Symbia Intevo Bold (2017), 63 descendants of its own

## Recalls of this device
- Sep 17, 2007 · Not classified · Z-0304-2008: Unintended Motion: A hardware fault in the c.cam system can cause the system to experience unintended motion, thereby causing a collision hazard.
- Apr 30, 2007 · Not classified · Z-0906-2007: Chair Breakage: Under extreme load, the chair back of the c.cam emission computed tomography system may bend and eventually break. This could be caused by the accumulated stress from heavy patients se

## Indications for use
Virgo is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data The device includes display equipment, patient and equipment supports, component parts, and accessories. Virgo is primarily intended for cardiac applications but the Virgo design also supports non-cardiac procedures of the patient’s chest region and body extremities. Virgo supports radionuclides within the energy range of 60 - 170 keV

Source page: https://510kreport.com/device/K031825
Methodology: https://510kreport.com/methodology