# K040616: Cardiomd-AC

- Pathway: 510(k) (Abbreviated)
- Applicant: Danish Diagnostic Development A/S
- Decided: Mar 24, 2004 after 15 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
87 later devices descend from it; 1 cites it directly.
6 of 88 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
- K051460: C.Cam-AC (2005), 86 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

## 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 CardioMD-AC Attenuation Correction option is to provide the costumer with means to measure the attenuation of gamma rays within the body of a patient, when using a DDD CardioMD gamma camera system type 9CSY0799 for SPECT studies, and to map the measured attenuation into images that can be used to compensate emission images for the attenuation. The CardioMD-AC includes additional acquisition of data for scatter correction of these images.

Source page: https://510kreport.com/device/K040616
Methodology: https://510kreport.com/methodology