# K051460: C.Cam-AC

- Pathway: 510(k) (Traditional)
- Applicant: Danish Diagnostic Development A/S
- Decided: Jun 15, 2005 after 12 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
Longest line of descent: 1 generation back to K963983 (1997). 2 ancestors in all.
86 later devices descend from it; 1 cites it directly.
6 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040616: Cardiomd-AC, Danish Diagnostic Development A/S (2004) Summary page 1.
- K963983: E. Cam Profile Attenuation Correction, Siemens Corp. (1997) 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
- Mar 6, 2015 · Class II · Z-1784-2015: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overh

## Indications for use
Attenuation correction is a method where the emission images acquired during SPECT acquisitions are compensated for attenuation within the patient. The purpose of attenuation correction is to compensate for varying attenuation of gamma rays in the body. The intended use of the c.cam Attenuation Correction option is to provide the customer with means to measure the attenuation of gamma rays within the body of a patient, when using a c.cam gamma camera system for SPECT studies, and to map the measured attenuation into images that can be used to compensate emission images for the attenuation. The c.cam-AC includes additional acquisition of data for scatter correction of these images.

Source page: https://510kreport.com/device/K051460
Methodology: https://510kreport.com/methodology