# K051418: Direct Digitizer Regius  Model 370

- Pathway: 510(k) (Special)
- Applicant: Konica Minolta Medical & Graphic, Inc.
- Decided: Jul 1, 2005 after 30 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 1 cites it directly.
0 of 25 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
- K082347: Digital Radiography, Flexdr C30 (2008), 23 descendants of its own
- K102349: Aerodr System (2010), 22 descendants of its own
- K120477: Aerosync for Aerodr System (2012), 14 descendants of its own
- K113248: Aerodr System with P-21 (2012), 14 descendants of its own
- K130936: Aerodr System with P-31 (2013), 13 descendants of its own

## Recalls of this device
- Jul 14, 2006 · Not classified · Z-1481-06: A hand grip column, even though locked in position, moved downward about 3 cm while a patient was holding the hand grip for lateral exposure. When the hand grip moved down, the patient who was holding

## Indications for use
The Direct Digitizer, REGIUS MODEL 370 is an X-ray image controller which uses a Simulative phosphor as X-ray detector and intended to control and manages digital X-ray image file processing. The REGIUS MODEL 370 is NOT intended for use with digital mammography system.

Source page: https://510kreport.com/device/K051418
Methodology: https://510kreport.com/methodology