510(k) K014022
K014022 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 March 4, 2002. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. I.Z.I. Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 2002
- Date Received
- December 6, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type