Clearance Summary
3MP Monochrome Digital Mammography LCD Monitor MS-S300 received FDA 510(k) clearance under submission number K200161, sponsored by Jvckenwood Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-02-21.
- Submission: K200161
- Applicant / Sponsor: Jvckenwood Corporation
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2020-02-21
Classification & Regulation
This clearance is catalogued under FDA product code PGY and 21 CFR 892.2050, within the Radiology review panel as a Class II device.