Regius SIGMA2
FDA 510(k) K120131 · Konica Minolta Medical & Graphic, Inc.
510(k) numberK120131
Submission
- Device name
- Regius SIGMA2
- Applicant
- Konica Minolta Medical & Graphic, Inc.
New York, NY, US - Received
- January 17, 2012
- Decision date
- February 10, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K120752 | Aerodr Stitching SystemKPR · Traditional | 06/08/2012SE |
| K121109 | Aerodr X70KPR · Traditional | 05/23/2012SE |
| K120477 | Aerosync for Aerodr SystemMQB · Traditional | 04/09/2012SE |
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| K110717 | Konica Minolta Xpress Digital Mammography SystemMUE · Traditional | 12/23/2011SE |
| K103703 | Reguis SigmaMQB · Traditional | 06/02/2011SE |
| K101842 | AciesLLZ · Traditional | 02/04/2011SE |
| K102349 | Aerodr SystemKPR · Traditional | 11/24/2010SE |
Questions and answers
When was Regius SIGMA2 cleared by the FDA?
Regius SIGMA2 (K120131) received a 510(k) decision of Substantially Equivalent on February 10, 2012, 24 days after the submission was received.
What is the product code of K120131?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.