MREplus+ Software
510(k) K183193
MREplus+ Software is a Class II device made by Resoundant, Inc., cleared under FDA 510(k) K183193 on 1 Aug 2019, 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 | NumberK183193 | Date1 Aug 2019 | StatusActive |
Official records
- FDA 510(k) database K183193
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K183193
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 | |||
|---|---|---|---|---|
| Hepatogram Plus 3.0DKR | MREPLUSV3 / 3.0DKR | 00850011790199 | — | On the market |
| MREplus 3.0.0DKR | MREplus 3.0.0DKR | 00850011790007 | — | No longer on the market |
| MREplus 3.0.0WIN | MREplus 3.0.0WIN | 00850011790014 | — | No longer on the market |
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