Direct Digitizer Regius Model 190

No FDA recalls on record, checked 22 Oct 2026.

Full name

Modification to: Direct Digitizer Regius Model 190

510(k) Number

K052095 ↗

FDA Product Code

MQB

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Reguis Sigma

  Class II

  FDA 510(k) K103703 Active Cleared 2 Jun 2011

• Direct Digitizer, Regius Model 110

  Class II

  FDA 510(k) K071181 Active Cleared 30 May 2007

• Konica Minolta Xpress Digital Mammography System

  Class II

  FDA 510(k) K110717 Active Cleared 23 Dec 2011

• Direct Digitizer, Regius Model 210

  Class II

  FDA 510(k) K092717 Active Cleared 30 Oct 2009

• Regius Unitea

  Class II

  FDA 510(k) K071436 Active Cleared 27 Jun 2007

• Konica Direct Digitizer Regius Model 350

  Class II

  FDA 510(k) K013054 Active Cleared 1 Mar 2002

See all devices from Konica Minolta Medical & Graphic, Inc. →

• Is the Direct Digitizer Regius Model 190 designed for single-use or can it be reused in clinical settings?

  The Direct Digitizer Regius Model 190 is explicitly described as a reusable medical instrument, meaning it is intended for repeated use in radiology settings after proper cleaning and maintenance. This aligns with its classification as a Class II device and its regulatory compliance under 21 CFR 892.1680, which governs reusable radiographic imaging systems.

• What type of imaging technology does the Direct Digitizer Regius Model 190 use, and how does it benefit diagnostic radiology?

  The Regius Model 190 employs solid-state X-ray imager (flat-panel/digital imager) technology, converting X-ray exposure into digital signals for high-resolution imaging. This enables rapid acquisition and real-time display of radiographic images, significantly improving diagnostic efficiency and workflow in radiology departments.

• How is the regulatory approval process for this device structured, and what committee was involved?

  The Direct Digitizer Regius Model 190 received FDA 510(k) clearance through a traditional review process, determined to be *substantially equivalent* to a predicate device. The submission was reviewed by the Radiology (RA) Advisory Committee, reflecting its classification under the Radiology advisory committee and compliance with 21 CFR 892.1680.

• Are there multiple models or configurations of the Direct Digitizer Regius, or is this a singular device?

  The provided data describes the Direct Digitizer Regius Model 190 specifically, without mentioning alternative models or configurations. However, the associated FEI numbers (e.g., 3009717300, 3015223550) suggest it may be part of a broader product line or have multiple variants linked to different registrations, though no distinct models are detailed in the description.