Clearance Summary
EXTEND FRAME SYSTEM, MODEL 1009633 received FDA 510(k) clearance under submission number K092083, sponsored by Elekta Instrument AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-09-22.
- Submission: K092083
- Applicant / Sponsor: Elekta Instrument AB
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5750
- Decision date: 2009-09-22
Classification & Regulation
This clearance is catalogued under FDA product code IWB and 21 CFR 892.5750, within the Radiology review panel as a Class II device.