# K011611: Cardiocam Model 9CSY0799

- Pathway: 510(k) (Traditional)
- Applicant: Danish Diagnostic Development A/S
- Decided: Jun 8, 2001 after 14 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
101 later devices descend from it; 3 cite it directly.
6 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K031825: C.CAM (2003), 98 descendants of its own
- 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

## Recalls of this device
- Jun 21, 2004 · Not classified · Z-1079-04: Software problems may cause the detector head to drift unexpectedly

## Indications for use
The Cardiocam system is a dual head system designed to acquire data for cardxac multi-slice images. The system is intended for use as diagnostic imaging device. When used with appropriate radio phaml.aceutlcals, images are produced representmg the internal distribution of radioactivity in the body. The system allows you to acquire data for lugh resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using Tc-99m, T1-201, Co-57.

Source page: https://510kreport.com/device/K011611
Methodology: https://510kreport.com/methodology