Regius SIGMA2
by Konica Minolta Medical & Graphic, Inc.
510(k) K120131
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120131 | Date10 Feb 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MQB
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The device is a Solid State X-Ray Imager (Flat Panel/Digital Imager) used in radiology. It is a computed radiography system designed for digital image acquisition.
It is supplied as a reusable system for use in healthcare settings. The device has FDA 510(k) clearance under product code MQB and regulation number 892.1680, with special clearance type and substantial equivalence determination.
Other devices from Konica Minolta Medical & Graphic, Inc.
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Questions
AI-generated answers, 24 Sep 2026
What is the REGIUS SIGMA2 used for?
The REGIUS SIGMA2 is a Solid State X-Ray Imager designed for digital image acquisition in radiology. It functions as a computed radiography system that captures and processes digital images for diagnostic purposes in healthcare settings.
How is the REGIUS SIGMA2 supplied?
The REGIUS SIGMA2 is supplied as a reusable system for use in healthcare settings. It is designed for repeated use rather than being a single-use device, making it a cost-effective solution for facilities that perform regular radiographic examinations.
What is the regulatory status of the REGIUS SIGMA2?
The REGIUS SIGMA2 has FDA 510(k) clearance under product code MQB and regulation number 892.1680. It received a special clearance type with substantial equivalence determination, indicating it meets the necessary safety and effectiveness requirements for its intended use.
What sizes and models of the REGIUS SIGMA2 are available?
The device data does not specify different sizes or models of the REGIUS SIGMA2. The information provided indicates a single system configuration designed for general radiographic imaging purposes in healthcare settings.