510(k) K970782
K970782 is an FDA 510(k) premarket notification submitted by General Robotic Devices, Inc. for the device "IMAGING JET SYSTEM". The FDA issued a decision of Substantially Equivalent on November 13, 1997. The device falls under product code JAB (System, X-Ray, Fluoroscopic, Non-Image-Intensified), a Class II device regulated under 21 CFR 892.1660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 1997
- Date Received
- March 4, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Fluoroscopic, Non-Image-Intensified
- Device Class
- Class II
- Regulation Number
- 892.1660
- Review Panel
- RA
- Submission Type