Ox-Imager CS
510(k) K153426
Ox-Imager CS is a Class II device made by Modulated Imaging Inc., cleared under FDA 510(k) K153426 on 21 Dec 2016, active as of 8 Nov 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 | NumberK153426 | Date21 Dec 2016 | StatusActive |
Official records
- FDA 510(k) database K153426
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUD
- FDA applicant
- Modulated Imaging, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2700
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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