Clearance Summary
MODIFICATION TO MEDSTATION received FDA 510(k) clearance under submission number K021934, sponsored by Aisoftw@Re Medical, S.P.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2002-08-12.
- Submission: K021934
- Applicant / Sponsor: Aisoftw@Re Medical, S.P.A.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2002-08-12
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.