# K101768: Mie Scintron Gamma Camera Systems

- Pathway: 510(k) (Traditional)
- Applicant: Miegmbh
- Decided: Oct 5, 2010 after 104 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: 5 generations back to K952674 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101013: Modification to Scintron IV, Miegmbh (2010) Summary page 1.
- K963983: E. Cam Profile Attenuation Correction, Siemens Corp. (1997) Summary page 1.

## Indications for use
The ECAM SCIINTRON Gamma Camera System for diagnostic nuclear medicine is used to perform static, dynamic and gated studies (non positron emitting tomography), as well as SPECT or planar procedure on standing, seated or recumbent patients.

Source page: https://510kreport.com/device/K101768
Methodology: https://510kreport.com/methodology