FDA-cleared K182336
SubtlePET
Subtle Medical, Inc.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2018-11-30
Vendor
Subtle Medical, Inc.
8 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K191688
SubtleMR
Subtle Medical, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2019-09-16
FDA-cleared K203182
SubtleMR
Subtle Medical, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-02-26
FDA-cleared K211964
SubtlePET
Subtle Medical, Inc.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2021-09-28
FDA-cleared K223623
SubtleMR (2.3.x)
Subtle Medical Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-05-11
FDA-cleared K241329
SubtleSYNTH (1.x)
Subtle Medical, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-07-11
FDA-cleared K240290
AiMIFY (1.x)
Subtle Medical, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-08-21
FDA-cleared K243250
SubtleHD (1.x)
Subtle Medical, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-02-12