# K052447: Synerad Impact 60, Synerad Impact 72 and Analogic AMS1600

- Pathway: 510(k) (Abbreviated)
- Applicant: Analogic Corp.
- Decided: Sep 21, 2005 after 14 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
Longest line of descent: 4 generations back to K903701 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033502: Lightspeed 6.0 CT Scanner System, Ge Medical Systems, LLC (2003) Summary page 2.
- K030420: Lightspeed 5.0 Computed Tomography System, GE Medical Systems (2003) Summary page 2.
- K020385: CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101A, Toshiba America Medical Systems, In.C (2002) Summary page 2.
- K022050: CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion Advance Multi), Toshiba America Medical Systems, In.C (2002) Summary page 2.

## Indications for use
The SyneRad IMpact 60, SyneRad IMpact 72 and Analogic AMS1600 are Computed Tomography X-ray Systems intended to produce images of the head and whole body by computer reconstruction of X-ray transmission data at different angle and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Source page: https://510kreport.com/device/K052447
Methodology: https://510kreport.com/methodology