# K053086: Mie - Gamma Camera Systems

- Pathway: 510(k) (Traditional)
- Applicant: Mie America, Inc.
- Decided: Jan 27, 2006 after 86 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SIEMENS ORBITER II CCI / Spect: named in the summary without a submission number
- (no number) Siemens Diacam Gamma Camera: named in the summary without a submission number
- (no number) Siemens Multispect 2 Dual Detector Camera System: named in the summary without a submission number
- (no number) Siemens Multispect TM3 Triple Detector Camera System: named in the summary without a submission number
- (no number) Siemens Bodyscan: named in the summary without a submission number
- (no number) BASICAM Counter balanced: named in the summary without a submission number
- (no number) GE Starcam 4000: named in the summary without a submission number
- (no number) GE Maxicamera 400 ac: named in the summary without a submission number

## Indications for use
The MIE - Gamma Camera Systems for nuclear medicine, are used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients

Source page: https://510kreport.com/device/K053086
Methodology: https://510kreport.com/methodology