510(k) K041521
K041521 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems for the device "VOLUME VIEWER PLUS". The FDA issued a decision of Substantially Equivalent on June 22, 2004. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. General Electric Medical Systems has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 2004
- Date Received
- June 8, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type