Clearance Summary
MODIFIED CASS SYSTEM received FDA 510(k) clearance under submission number K902488, 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 1990-12-07.
- Submission: K902488
- Applicant / Sponsor: Medical Instrumentation & Diagnostics Corp.(Midco)
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 1990-12-07
Classification & Regulation
This clearance is catalogued under FDA product code KXK and 21 CFR 892.5730, within the Radiology review panel as a Class II device.