# K021949: Fulcrum

- Pathway: 510(k) (Traditional)
- Applicant: Howtek, Inc.
- Decided: Aug 12, 2002 after 60 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 MultiRAD: named in the summary without a submission number

## Most influential descendants
- K091288: Medi-6000 Medical Image Digitizer (2009), 0 descendants of its own

## Indications for use
The Howtek Fulcrum Family consists of a transparency film digitizer and paper CCD scanner that is used to digitize radiographs or X-ray film as well as paper reports or doctor's orders. When the Fulcrum is used to digitize radiographic films, the digital image is intended for use in primary, secondary and over reading applications. The Fulcrum Family does not include applications specific software (Picture Archiving and Communications (PAC) system, Teleradiology, or Computer Aided Detection (CAD) software). The manufacturer of the application software will determine specific indications for use. These third-party software packages or complete PAC systems are approved separately.

Source page: https://510kreport.com/device/K021949
Methodology: https://510kreport.com/methodology