# K974455: Anatom 1000 (a Minus, a-)

- Pathway: 510(k) (Traditional)
- Applicant: Analogic Corp.
- Decided: Feb 20, 1998 after 87 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 no predicate by number.

## Indications for use
The Anatom 1000 system is intended to be used as a diagnostic x-ray device, for the purpose of obtaining cross-sectional images of the whole body by computer reconstruction of X-ray data, from the same axial plane taken at different angles. This device includes signal analysis and display equipment, patient and equipment supports, component parts and accessories. Additionally, the Anatom 1000 system can be field upgraded to either an “A” system or an “HA+” system which includes the capabilities of Helical Scanning (Volumetric scanning) and MPR (Multi-planar Reconstruction).

Source page: https://510kreport.com/device/K974455
Methodology: https://510kreport.com/methodology