FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
qER
K Number: K200921
·
Decision Jun 17, 2020
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
85
Applicant Total
9
Review Days
72
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Basic Information
- Device Name
- qER
- K Number
- K200921
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qure.Ai Technologies
- Date Received
- April 6, 2020
- Decision Date
- June 17, 2020
- Product Code
- QAS
- 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 |
|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | FDA class 2 | Radiology |
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Other Clearances by Qure.Ai Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K251934 | qXR-Detect | Jan 16, 2026 | Substantially Equivalent |
| K251610 | qER-CTA (v1.0) | Sep 8, 2025 | Substantially Equivalent |
| K240740 | qCT LN Quant | Aug 16, 2024 | Substantially Equivalent |
| K231805 | qXR-LN | Dec 22, 2023 | Substantially Equivalent |
| K231149 | qXR-CTR | Sep 22, 2023 | Substantially Equivalent |
| K230899 | qXR-PTX-PE | Aug 22, 2023 | Substantially Equivalent |
| K212690 | qXR-BT | Dec 21, 2021 | Substantially Equivalent |
| K211222 | qER-Quant | Jul 30, 2021 | Substantially Equivalent |