FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Optimized Positioning System (OPS) Insight
K Number: K202805
·
Decision Nov 20, 2020
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
9
Review Days
58
Basic Information
- Device Name
- Optimized Positioning System (OPS) Insight
- K Number
- K202805
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corin USA
- Date Received
- September 23, 2020
- Decision Date
- November 20, 2020
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by Corin USA
| K Number | Device Name | ||
|---|---|---|---|
| K203751 | OMNIVision system | Apr 12, 2021 | Substantially Equivalent |
| K193545 | Corin Optimized Positioning System (OPS) Femoral | Aug 4, 2020 | Substantially Equivalent |
| K193042 | Optimized Positioning System (OPS) ReView | Jun 26, 2020 | Substantially Equivalent |
| K192656 | Optimized Positioning System (OPS) Insight | May 1, 2020 | Substantially Equivalent |
| K190143 | LARS AC Band Device | Nov 4, 2019 | Substantially Equivalent |
| K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | Jul 22, 2019 | Substantially Equivalent |
| K183038 | Corin Optimized Positioning System (OPS) Plan | Nov 26, 2018 | Substantially Equivalent |
| K181061 | Corin Optimized Positioning System (OPS) Femoral | Sep 7, 2018 | Substantially Equivalent |