FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SubtleHD (1.x)
K Number: K243250
·
Decision Feb 12, 2025
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
11
Review Days
120
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
- SubtleHD (1.x)
- K Number
- K243250
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Subtle Medical, Inc.
- Date Received
- October 15, 2024
- Decision Date
- February 12, 2025
- 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 Subtle Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254120 | SubtleHD-CT (1.x) | May 15, 2026 | Substantially Equivalent |
| K254013 | SubtleHD-PET (1.x) | May 14, 2026 | Substantially Equivalent |
| K240290 | AiMIFY (1.x) | Aug 21, 2024 | Substantially Equivalent |
| K241329 | SubtleSYNTH (1.x) | Jul 11, 2024 | Substantially Equivalent |
| K233699 | SubtleREFORMAT (1.x) | Apr 29, 2024 | Substantially Equivalent |
| K223623 | SubtleMR (2.3.x) | May 11, 2023 | Substantially Equivalent |
| K211964 | SubtlePET | Sep 28, 2021 | Substantially Equivalent |
| K203182 | SubtleMR | Feb 26, 2021 | Substantially Equivalent |
| K191688 | SubtleMR | Sep 16, 2019 | Substantially Equivalent |
| K182336 | SubtlePET | Nov 30, 2018 | Substantially Equivalent |