510(k) K970782
- Device
- IMAGING JET SYSTEM
- Applicant
- GENERAL ROBOTIC DEVICES, INC.
- 510(k) number
- K970782
- Product code
- JAB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-11-13
- Date received
- 1997-03-04
- Regulation
- 892.1660
- Classification name
- System, X-ray, Fluoroscopic, Non-image-intensified
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- YANSONG SHAN
- Address
- 2069 Golfside Dr. Ypsilanti MI US 48197 48197
FDA Registration Numbers#
- 3011050570
- 3021008900
Source Documents#
Other 510(k) Records For Product Code JAB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K813032 | ZIKON 100 DIGITAL X-RAY SYSTEM | Kontron Instruments, Inc. | 1981-11-24 |
Legacy Summary#
summary
FDA Review#
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