510(k) K032280
K032280 is an FDA 510(k) premarket notification submitted by Siemens AG for the device "SIREMOBIL ISO-C 3D". The FDA issued a decision of Substantially Equivalent on September 10, 2003. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Siemens AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 10, 2003
- Date Received
- July 24, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type