510(k) K031206
K031206 is an FDA 510(k) premarket notification submitted by Radiomed Corp. for the device "RADIOMED SOFT TISSUE MARKER". The FDA issued a decision of Substantially Equivalent on May 21, 2003. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Radiomed Corp. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 2003
- Date Received
- Apr 16, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
- 510(k)