Clearance Summary
MED-SEG, MODEL BTMS 1000 received FDA 510(k) clearance under submission number K092328, sponsored by Bartron Medical Imaging, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2010-07-26.
- Submission: K092328
- Applicant / Sponsor: Bartron Medical Imaging, Inc.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2010-07-26
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.