3DSCOPE
3DSCOPE is a Class II device made by Direx Systems Corp., listed in FDA GUDID since 1 Nov 2016 (UDI-DI 00863499000322), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00863499000322 | Date1 Nov 2016 | StatusListed |
Official records
- AccessGUDID record 00863499000322
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Fluoroscopic x-ray system video image recording unit
- Model / reference
- 3DSCOPE
- Primary DI / UDI-DI
- 00863499000322
- FDA product code
- JAA
- GMDN term
- Fluoroscopic x-ray system video image recording unit
- Device class
- Class II
- Regulation number
- 892.1650
- GUDID distribution status
- In Commercial Distribution
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