# K101013: Modification to Scintron IV

- Pathway: 510(k) (Special)
- Applicant: Miegmbh
- Decided: Jun 7, 2010 after 56 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: 4 generations back to K952674 (1995). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953193: Scintron IV, Medical Imaging Electronics America, Inc. (1995) Summary page 1.
- K023190: E.Cam Computer / E.Soft Workstation, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.
- K914350: Icon Computer System, Siemens Gammasonics, Inc. (1991) Summary page 1.
- K080575: CORRIDOR4DM, Invia (2008) Summary page 1.

## Most influential descendants
- K101768: Mie Scintron Gamma Camera Systems (2010), 0 descendants of its own

## Indications for use
The SCINTRON workstation for diagnostic nuclear medicine is designed for acquiring, processing and reviewing data from all type of MiE and Siemens digital and analog gamma cameras. The SCINTRON is used to perform static, dynamic and gated studies, as well as SPECT (non positron emitting tomography), whole body or planar. procedure, on standing, seated or recumbent patients.

Source page: https://510kreport.com/device/K101013
Methodology: https://510kreport.com/methodology