trophon2
FDA 510(k) clearance K173865 · decided 2018-04-24
Clearance details
- K-number
- K173865
- Device name
- trophon2
- Applicant
- Nanosonics Limited
- Decision
- Substantially Equivalent
- Date received
- 2017-12-20
- Decision date
- 2018-04-24
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- OUJ
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Lane Cove, AU
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Nanosonics Limited
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| trophon Wireless Ultrasound Probe Holder (K241536) | Nanosonics Limited | 2024-09-27 |
| TROPHON (K103059) | Nanosonics Limited | 2011-02-24 |
Recalls involving this device
No recalls on record reference this clearance.