510(k) K991600
K991600 is an FDA 510(k) premarket notification submitted by Siemens Corp. for the device "SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION". The FDA issued a decision of Substantially Equivalent on June 9, 1999. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Siemens Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 1999
- Date Received
- May 10, 1999
- 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