Clearance Summary
COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED received FDA 510(k) clearance under submission number K921740, sponsored by Medical Instrumentation & Diagnostics Corp.(Midco). The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1993-04-07.
- Submission: K921740
- Applicant / Sponsor: Medical Instrumentation & Diagnostics Corp.(Midco)
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 1993-04-07
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.