510(k) K981466
K981466 is an FDA 510(k) premarket notification submitted by Imaging Sciences Intl., Inc. for the device "XR-910". The FDA issued a decision of Substantially Equivalent on July 14, 1998. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Imaging Sciences Intl., Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 1998
- Date Received
- April 23, 1998
- Clearance Type
- Traditional
- 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