FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
qXR-BT
K Number: K212690
·
Decision Dec 21, 2021
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
9
Review Days
118
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Basic Information
- Device Name
- qXR-BT
- K Number
- K212690
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qure.Ai Technologies
- Date Received
- August 25, 2021
- Decision Date
- December 21, 2021
- Product Code
- QIH
- 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 |
|---|---|---|---|
| QIH | Automated Radiological Image Processing 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 |
| K211222 | qER-Quant | Jul 30, 2021 | Substantially Equivalent |
| K200921 | qER | Jun 17, 2020 | Substantially Equivalent |