# K980873: Konica Direct Digitizer Regius Model 330

- Pathway: 510(k) (Traditional)
- Applicant: Konica Corp.
- Decided: Jun 19, 1998 after 105 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K013054: Konica Direct Digitizer Regius Model 350 (2002), 0 descendants of its own

## Indications for use
Reading, processing, displaying and printing X-ray images from exposed photostimulable phosphor plates.

Source page: https://510kreport.com/device/K980873
Methodology: https://510kreport.com/methodology