510(k) K003736
K003736 is an FDA 510(k) premarket notification submitted by I.Z.I. Corp. for the device "MRI LINE MARKER". The FDA issued a decision of Substantially Equivalent on January 18, 2001. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. I.Z.I. Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2001
- Date Received
- December 4, 2000
- Clearance Type
- Traditional
- 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