Clearance Summary
RADIOMED SOFT TISSUE MARKER received FDA 510(k) clearance under submission number K031206, sponsored by Radiomed Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2003-05-21.
- Submission: K031206
- Applicant / Sponsor: Radiomed Corp.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2003-05-21
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.