Kosmos P008041
by EchoNous
Kosmos P008041 is a Class II device made by EchoNous, cleared under FDA 510(k) K212100 on 6 Aug 2021 and listed in FDA GUDID since 8 Aug 2025 (UDI-DI 09353278000847), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number09353278000847 | Date8 Aug 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212100 | Date6 Aug 2021 | StatusActive |
Official records
- AccessGUDID record 09353278000847
- FDA 510(k) database K212100
Across registries
- FDA 510(k) K212100 decided 6 Aug 2021 Active
- FDA GUDID UDI-DI 09353278000847 listed 8 Aug 2025 Listed
Recalls
-
- Ongoing Z-2325-2024
Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment.
Timeline
- Cleared FDA 510(k) K212100
- Recall initiated FDA recalls Z-2325-2024
- Listed FDA GUDID 09353278000847
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kosmos
- Generic name
- Extracorporeal ultrasound imaging transducer, hand-held
- Model / reference
- P008041
- Primary DI / UDI-DI
- 09353278000847
- 510(k) Number
- FDA product code
- IYN
- GMDN term
- Extracorporeal ultrasound imaging transducer, hand-held
- Device class
- Class II
- Regulation number
- 892.1550
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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