FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOTA Cloud Imaging
K Number: K210682
·
Decision May 4, 2021
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
2
Review Days
57
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Basic Information
- Device Name
- SOTA Cloud Imaging
- K Number
- K210682
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sota Precision Optics, Inc. Dba Sota Imaging
- Date Received
- March 8, 2021
- Decision Date
- May 4, 2021
- 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 Sota Precision Optics, Inc. Dba Sota Imaging
| K Number | Device Name | ||
|---|---|---|---|
| K202664 | Clio Prime and Clio Pedo | Nov 6, 2020 | Substantially Equivalent |