FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
K Number: K253459
·
Decision Apr 24, 2026
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
45
Applicant Total
57
Review Days
199
Basic Information
- Device Name
- OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
- K Number
- K253459
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ABBOTT MEDICAL
- Date Received
- October 7, 2025
- Decision Date
- April 24, 2026
- Product Code
- NQQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | FDA class 2 | Radiology |
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