# K023061: Konica Direct Digitizer Regius, Model 170

- Pathway: 510(k) (Special)
- Applicant: Konica Minolta Medical & Graphic, Inc.
- Decided: Oct 11, 2002 after 25 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 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
- K042386: Direct Digitizer, Regius Model 190 (2004), 5 descendants of its own
- K052095: Modification to: Direct Digitizer Regius Model 190 (2005), 4 descendants of its own
- K071181: Direct Digitizer, Regius Model 110 (2007), 2 descendants of its own
- K103703: Reguis Sigma (2011), 1 descendant of its own
- K051998: Regius Model 170 Direct Digitizer (2005), 1 descendant of its own

## Indications for use
The Konica Direct Digitizer Model 170 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.

Source page: https://510kreport.com/device/K023061
Methodology: https://510kreport.com/methodology