# K970908: Howtek 960

- Pathway: 510(k) (Traditional)
- Applicant: Howtek, Inc.
- Decided: May 20, 1997 after 70 days
- Product code: LMA (Digitizer, Image, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2030
- 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) Howtek Scanmaster DX: named in the summary without a submission number

## Indications for use
The device is used in generating digital signals from medical radiographs. The digital signals are intended for use in PACS and tele-radiology.

Source page: https://510kreport.com/device/K970908
Methodology: https://510kreport.com/methodology