510(k) K103489
K103489 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "GE VEO RECONSTRUCTION OPTION". The FDA issued a decision of Substantially Equivalent on September 9, 2011. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. General Electric Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2011
- Date Received
- November 26, 2010
- 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