# K020243: Laserpro 16

- Pathway: 510(k) (Traditional)
- Applicant: Eradlink, Inc.
- Decided: Mar 5, 2002 after 41 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
Longest line of descent: 3 generations back to K952914 (1995). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980213: DI-2000, Lumisys, Inc. (1998) Summary page 2.
- (no number) Lumiscan 75: named in the summary without a submission number

## Most influential descendants
- 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
The LaserPro 16 is a desk top laser image digitizer intended to produce digital copies of radiological film in 16 levels of gray scale. The digital copies are transmitted to a Pentium based personal computer (PC) where they may be displayed, processed, or compressed for archiving or transmission via computer networks to other medical facility sites.

Source page: https://510kreport.com/device/K020243
Methodology: https://510kreport.com/methodology