Clearance Summary
INFRARED SCIENCES BREASTSCAN IR SYSTEM received FDA 510(k) clearance under submission number K032350, sponsored by Infrared Sciences Corp.. 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 2004-02-20.
- Submission: K032350
- Applicant / Sponsor: Infrared Sciences Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 2004-02-20
Classification & Regulation
This clearance is catalogued under FDA product code LHQ and 21 CFR 884.2980, within the Obstetrics/Gynecology review panel as a Class I device.