Direct Digitizer Regius Model 190

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K042386 ↗

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

• Direct Digitizer Regius Model 190

  Class II

  FDA 510(k) K052095 Active Cleared 3 Nov 2005

• Regius Unitea

  Class II

  FDA 510(k) K071436 Active Cleared 27 Jun 2007

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

• What is the primary purpose of the Direct Digitizer, Regius Model 190 in a clinical setting?

  The Direct Digitizer, Regius Model 190 is designed as a Solid State X-Ray Imager (Flat Panel/Digital Imager) to convert X-ray images into electronic signals for immediate display and processing. It serves as a digital radiographic detector, enabling high-resolution diagnostic imaging in radiology departments by interfacing with X-ray systems to capture and digitize radiographic images.

• Is the Regius Model 190 a single-use or reusable device, and what does this mean for maintenance?

  The Regius Model 190 is reusable, meaning it is intended for repeated use in clinical settings. Since it is not single-use, it requires proper calibration and maintenance to ensure consistent imaging performance and accuracy over time. Regular upkeep is essential to comply with regulatory standards for digital radiographic imaging.

• How is the Regius Model 190 regulated, and what does this imply for its use in medical facilities?

  The Regius Model 190 holds an FDA 510(k) clearance under the Radiology advisory committee, classified as a Class II device (regulation number 892.1680). This means it has been determined to be substantially equivalent to a legally marketed device and is intended for professional medical use only, adhering to strict regulatory standards for digital radiographic imaging.

• What types of X-ray imaging applications is the Regius Model 190 suitable for?

  While the device data does not specify exact clinical indications, the Regius Model 190 is a Solid State X-Ray Imager (Flat Panel/Digital Imager) designed for general radiographic imaging in radiology departments. It is intended for use with X-ray systems to capture and digitize images, making it suitable for standard diagnostic imaging tasks such as bone imaging, chest X-rays, and other common radiographic procedures.