Clearance Summary
ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS received FDA 510(k) clearance under submission number K002132, sponsored by Intelligent Instruments Pvt. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-10-18.
- Submission: K002132
- Applicant / Sponsor: Intelligent Instruments Pvt. , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2001-10-18
Classification & Regulation
This clearance is catalogued under FDA product code MUJ and 21 CFR 892.5050, within the Radiology review panel as a Class II device.