LOGIQ Focus
FDA 510(k) clearance K261835 · decided 2026-07-30
Clearance details
- K-number
- K261835
- Device name
- LOGIQ Focus
- Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2026-06-02
- Decision date
- 2026-07-30
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.