Clearance Summary
HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES received FDA 510(k) clearance under submission number K954294, sponsored by Thermotrex Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1996-02-02.
- Submission: K954294
- Applicant / Sponsor: Thermotrex Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1910
- Decision date: 1996-02-02
Classification & Regulation
This clearance is catalogued under FDA product code IXJ and 21 CFR 892.1910, within the Radiology review panel as a Class I device.