Odyssey Workstation
by Stereotaxis, Inc. 2 variants
510(k) K093092
Odyssey Workstation is a Class II device made by Stereotaxis, Inc., cleared under FDA 510(k) K093092 on 21 Jan 2010, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK093092 | Date21 Jan 2010 | StatusActive |
Official records
- FDA 510(k) database K093092
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DQK
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1425
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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