Preirus Hv-Preirus
Preirus Hv-Preirus is a Class II device made by PENTAX of America Inc., cleared under FDA 510(k) K093466 on 17 Jun 2010 and listed in FDA GUDID since 12 Mar 2018 (UDI-DI 04961333243112), active as of 8 Nov 2026.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04961333243112 | Date12 Mar 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093466 | Date17 Jun 2010 | StatusActive |
Official records
- AccessGUDID record 04961333243112
- FDA 510(k) database K093466
Across registries
- FDA 510(k) K093466 decided 17 Jun 2010 Active
- FDA GUDID UDI-DI 04961333243112 listed 12 Mar 2018 Listed
Recalls
-
- Terminated Z-2467-2011
Software anomaly. The Doppler Trace Measurement feature on certain models of the firm's diagnostic ultrasound systems, may, under certain conditions whereby multiple measurements are done sequentially, record incorrect values. The recorded value is displayed to the user on a report; however depending upon the measurement area, displayed velocity values could be lower than at the true velocity lead
Timeline
- Cleared FDA 510(k) K093466
- Recall initiated FDA recalls Z-2467-2011
- Listed FDA GUDID 04961333243112
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Preirus
- Generic name
- General-purpose ultrasound imaging system
- Model / reference
- HV-PREIRUS
- Primary DI / UDI-DI
- 04961333243112
- 510(k) Number
- FDA product code
- IYO
- GMDN term
- General-purpose ultrasound imaging system
- Device class
- Class II
- Regulation number
- 892.1560
- GUDID distribution status
- In Commercial Distribution
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