Lumify Diagnostic Ultrasound System
FDA 510(k) clearance K242670 · decided 2025-05-08
Clearance details
- K-number
- K242670
- Device name
- Lumify Diagnostic Ultrasound System
- Applicant
- Philips Ultrasound
- Decision
- Substantially Equivalent
- Date received
- 2024-09-05
- Decision date
- 2025-05-08
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841, recall (Z-0883-2026) | Philips Ultrasound, LLC | 2025-12-04 |