Paragon 2
by Meridian Medical Systems, LLC
510(k) K162687
Paragon 2 is a medical device (FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by Meridian Medical Systems, LLC, cleared under FDA 510(k) K162687 on 21 Oct 2016, 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 | NumberK162687 | Date21 Oct 2016 | StatusActive |
Official records
- FDA 510(k) database K162687
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IZL
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1720
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K162687
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Paragon 2 RT312 | RT312 | 00851354007159 | — | No longer on the market |
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