Clearance Summary
HEXAPOD EVO RT COUCH TOP received FDA 510(k) clearance under submission number K072898, sponsored by Medical Intelligence Medizintechnik GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2007-10-25.
- Submission: K072898
- Applicant / Sponsor: Medical Intelligence Medizintechnik GmbH
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5770
- Decision date: 2007-10-25
Classification & Regulation
This clearance is catalogued under FDA product code JAI and 21 CFR 892.5770, within the Radiology review panel as a Class II device.