510(k) K991518
K991518 is an FDA 510(k) premarket notification submitted by Imaging Sciences Intl., Inc. for the device "PANATOME". The FDA issued a decision of Substantially Equivalent on June 18, 1999. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Imaging Sciences Intl., Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 1999
- Date Received
- April 30, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, X-Ray, Extraoral With Timer
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type