OPXION Optical Skin Viewer (OPXSV1-01F)
FDA 510(k) clearance K242924 · decided 2025-06-23
Clearance details
- K-number
- K242924
- Device name
- OPXION Optical Skin Viewer (OPXSV1-01F)
- Applicant
- Opxion Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-24
- Decision date
- 2025-06-23
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- NQQ
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- New Taipei City, TW
- Third-party review
- No
- Expedited review
- No
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| deepLive (K240610) | Damae Medical | 2024-07-09 |
| ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6 (K232386) | ABBOTT MEDICAL | 2023-09-08 |
| HyperVue™ Imaging System (K230691) | Spectrawave, Inc. | 2023-06-07 |
Recalls involving this device
No recalls on record reference this clearance.