Clearance Summary
ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE. received FDA 510(k) clearance under submission number K872265, sponsored by Labsonics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1988-01-04.
- Submission: K872265
- Applicant / Sponsor: Labsonics, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2960
- Decision date: 1988-01-04
Classification & Regulation
This clearance is catalogued under FDA product code HGL and 21 CFR 884.2960, within the Obstetrics/Gynecology review panel as a Class II device.