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DIRECT DIGITIZER, REGIUS MODEL 110

K071181 Class II Special
Decision Date
2007-05-30
Sponsor / Applicant
Konica Minolta Medical & Graphic, Inc.

Technical Specification

510(k) Submission ID K071181
Product Code MQB
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1680
Decision Date 2007-05-30
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

DIRECT DIGITIZER, REGIUS MODEL 110 received FDA 510(k) clearance under submission number K071181, sponsored by Konica Minolta Medical & Graphic, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2007-05-30.

Classification & Regulation

This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.