# K073021: Multi-Spect

- Pathway: 510(k) (Traditional)
- Applicant: Eagle Heart Imaging, LLC
- Decided: Nov 6, 2007 after 11 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
Longest line of descent: 1 generation back to K790499 (1979). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790499: Multiple Pinhole Tomographic Collimoter, Engineering Dynamics Corp. (1979) Summary page 1.
- K791055: Adac Tomography Option, Adac Laboratories (1979) Summary page 1.
- K922080: Genesys II, Adac Laboratories (1992) Summary page 1.
- K992317: Autospect Plus with Instill Motion Correction, Adac Laboratories (1999) Summary page 1.

## Indications for use
The Multi-SPECT is intended for use as an accessory to an dual headed nuclear medicine gamma camera (for example - the ADAC Vertex Dual Headed Nuclear Medicine Camera). It is to be used to perform static, dynamic and/or gated Single Photon Emission Computed Tomography clinical nuclear medicine images of the heart. It is indicated for use to produce images showing the location and distribution of radioisotopes in the human body for interpretation by a physician.

Source page: https://510kreport.com/device/K073021
Methodology: https://510kreport.com/methodology