Clearance Summary
CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS received FDA 510(k) clearance under submission number K041542, sponsored by Neusoft Digital Medical Systems Co., 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 2004-06-17.
- Submission: K041542
- Applicant / Sponsor: Neusoft Digital Medical Systems Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2004-06-17
Classification & Regulation
This clearance is catalogued under FDA product code JAK and 21 CFR 892.1750, within the Radiology review panel as a Class II device.