FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
qCT LN Quant
K Number: K240740
·
Decision Aug 16, 2024
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
9
Review Days
151
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- qCT LN Quant
- K Number
- K240740
- 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
- March 18, 2024
- Decision Date
- August 16, 2024
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QIH), ordered by most recent decision date.
Synapse PACS (7.6.0)
FDA 510(k)
FDA Class 2
·Radiology
WatchMate Software
FDA 510(k)
FDA Class 2
·Radiology
MediAI-OA
FDA 510(k)
FDA Class 2
·Radiology
LungMaps
FDA 510(k)
FDA Class 2
·Radiology
Brainomix 360 Hyperdensity
FDA 510(k)
FDA Class 2
·Radiology
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
FDA 510(k)
FDA Class 2
·Radiology
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 |
| 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 |
| K200921 | qER | Jun 17, 2020 | Substantially Equivalent |