# K053210: Mayfield Scanmate Mobile CT System

- Pathway: 510(k) (Traditional)
- Applicant: Schaerer Mayfield USA, Inc.
- Decided: Jan 6, 2006 after 51 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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) Analogic Corporation's ANATOM 2000: named in the summary without a submission number

## Indications for use
The Mayfield® ScanMateTM Mobile CT System is intended for use as a Computed Tomography X-ray System for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles.

Source page: https://510kreport.com/device/K053210
Methodology: https://510kreport.com/methodology