# K970652: Mitra Imaging, Inc. Film Express Scanning Software

- Pathway: 510(k) (Traditional)
- Applicant: Mitra Imaging, Inc.
- Decided: May 2, 1997 after 70 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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) Lumisys DICOM TOOLKIT: named in the summary without a submission number
- (no number) Imageshare 910: named in the summary without a submission number
- (no number) Statview: named in the summary without a submission number

## 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

Source page: https://510kreport.com/device/K970652
Methodology: https://510kreport.com/methodology