trophon Wireless Ultrasound Probe Holder
FDA 510(k) clearance K241536 · decided 2024-09-27
Clearance details
- K-number
- K241536
- Device name
- trophon Wireless Ultrasound Probe Holder
- Applicant
- Nanosonics Limited
- Decision
- Substantially Equivalent
- Date received
- 2024-05-30
- Decision date
- 2024-09-27
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- OUJ
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Macquarie Park, AU
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| trophon2 (K250434) | Nanosonics | 2025-08-05 |
| trophon2 (K173865) | Nanosonics Limited | 2018-04-24 |
| TROPHON (K103059) | Nanosonics Limited | 2011-02-24 |
Recalls involving this device
No recalls on record reference this clearance.