# K972191: Digitizer Director (HSC025-01)

- Pathway: 510(k) (Traditional)
- Applicant: Howtek, Inc.
- Decided: Sep 8, 1997 after 90 days
- Product code: LMD (System, Digital Image Communications, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952914 (1995). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952914: Star Technologies, Inc. Film Image Scan System, Star Technologies, Inc. (1995) Summary page 1.

## Most influential descendants
- K980213: DI-2000 (1998), 5 descendants of its own
- K020243: Laserpro 16 (2002), 3 descendants of its own
- K052938: CR-PRO (2005), 2 descendants of its own
- K142718: Radlink GPS (2014), 1 descendant of its own
- K242161: Radlink GPS Pro Imaging (2025), 0 descendants of its own

## Indications for use
DIGITIZER DIRECTOR is a DICOM compatible software package which enables any medical facility personal computer (PC) with adequate memory and the appropriate film digitizer to perform secondary image capture of films using the Howtek film digitizer family. DIGITIZER DIRECTOR does not have any image compression capability. DIGITIZER DIRECTOR is an integrated DICOM network product which translates the images from proprietary digitizer format to DICOM format and sends them on to another DICOM application.

Source page: https://510kreport.com/device/K972191
Methodology: https://510kreport.com/methodology