510(k) K001928
K001928 is an FDA 510(k) premarket notification submitted by Instrumentarium Imaging, Inc. for the device "SIGMA". The FDA issued a decision of Substantially Equivalent on August 2, 2000. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Instrumentarium Imaging, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2000
- Date Received
- June 26, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type