FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
QOCA image Smart CXR Image Processing System
K Number: K221868
·
Decision Jan 27, 2023
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
39
Applicant Total
5
Review Days
214
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Basic Information
- Device Name
- QOCA image Smart CXR Image Processing System
- K Number
- K221868
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quanta Computer, Inc.
- Date Received
- June 27, 2022
- Decision Date
- January 27, 2023
- Product Code
- QFM
- 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 |
|---|---|---|---|
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | FDA class 2 | Radiology |
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Other Clearances by Quanta Computer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231855 | QOCA® image Smart RT Contouring System | Feb 13, 2024 | Substantially Equivalent |
| K210179 | QOCA Portable ECG Monitoring Device | Aug 2, 2022 | Substantially Equivalent |
| K083079 | QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100 | Mar 5, 2009 | Substantially Equivalent |
| K083078 | QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 | Nov 26, 2008 | Substantially Equivalent |