FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ilumien Optis, Optis Integrated, Optis Mobile
K Number: K183320
·
Decision Apr 2, 2019
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
45
Applicant Total
2
Review Days
123
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Basic Information
- Device Name
- Ilumien Optis, Optis Integrated, Optis Mobile
- K Number
- K183320
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- St. Jude Medical (Now Abbott Medical)
- Date Received
- November 30, 2018
- Decision Date
- April 2, 2019
- 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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Other Clearances by St. Jude Medical (Now Abbott Medical)
| K Number | Device Name | ||
|---|---|---|---|
| K183099 | QUANTIEN Measurement System | Feb 28, 2019 | Substantially Equivalent |