Subtle Medical, Inc.
Subtle Medical, Inc. appears in FDA public data with 0 recalls, 11 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on May 15, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 11
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K254120 | SubtleHD-CT (1.x) | May 15, 2026 |
| K254013 | SubtleHD-PET (1.x) | May 14, 2026 |
| K243250 | SubtleHD (1.x) | Feb 12, 2025 |
| K240290 | AiMIFY (1.x) | Aug 21, 2024 |
| K241329 | SubtleSYNTH (1.x) | Jul 11, 2024 |
| K233699 | SubtleREFORMAT (1.x) | Apr 29, 2024 |
| K223623 | SubtleMR (2.3.x) | May 11, 2023 |
| K211964 | SubtlePET | Sep 28, 2021 |
| K203182 | SubtleMR | Feb 26, 2021 |
| K191688 | SubtleMR | Sep 16, 2019 |
| K182336 | SubtlePET | Nov 30, 2018 |