FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SubtlePET
K Number: K211964
·
Decision Sep 28, 2021
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
470
Applicant Total
11
Review Days
96
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Basic Information
- Device Name
- SubtlePET
- K Number
- K211964
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Subtle Medical, Inc.
- Date Received
- June 24, 2021
- Decision Date
- September 28, 2021
- Product Code
- KPS
- 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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | FDA class 2 | Radiology |
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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 |
| K243250 | SubtleHD (1.x) | Feb 12, 2025 | 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 |
| K203182 | SubtleMR | Feb 26, 2021 | Substantially Equivalent |
| K191688 | SubtleMR | Sep 16, 2019 | Substantially Equivalent |
| K182336 | SubtlePET | Nov 30, 2018 | Substantially Equivalent |