FDA-cleared K254120

SubtleHD-CT (1.x)

Subtle Medical, Inc.

Process and enhance CT images from any CT scanner manufacturer or model as an adjunct to the original reconstructed image.

Modality
CT/CTA
Anatomy
Multiple CT anatomies: abdomen, C-spine, cardiac, chest, chest-abdomen-pelvis, head, head/neck, L-spine, lower extremity, MSK, T-spine, and upper extremity.
Decision
2026-05-15
FDA-cleared K254013

SubtleHD-PET (1.x)

Subtle Medical, Inc.

SubtleHD-PET 1.x is image-processing software that reduces PET or PET/CT/PET-MR image noise for images acquired with any radiotracer within the labeled workflow.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole body and the body regions represented in PET studies
Decision
2026-05-14
FDA-cleared K243250

SubtleHD (1.x)

Subtle Medical, Inc.

MRI image enhancement through noise reduction and sharpening for clinical image review.

Modality
MRI
Anatomy
Whole Body
Decision
2025-02-12
FDA-cleared K240290

AiMIFY (1.x)

Subtle Medical, Inc.

Enhance GBCA-enhanced brain MRI images to improve lesion and tissue contrast for radiologist review while preserving the original post-contrast image context.

Modality
MRI
Anatomy
Brain
Decision
2024-08-21
FDA-cleared K241329

SubtleSYNTH (1.x)

Subtle Medical, Inc.

SubtleSYNTH is a software medical device consisting of a machine-learning algorithm that synthesizes a SynthSTIR contrast image from T1-weighted and T2-weighted spine MR images.

Modality
MRI
Anatomy
Spine
Decision
2024-07-11
FDA-cleared K223623

SubtleMR (2.3.x)

Subtle Medical Inc.

MRI image enhancement by reducing image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI, or increasing image sharpness for head MRI.

Modality
MRI
Anatomy
Head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal regions
Decision
2023-05-11
FDA-cleared K211964

SubtlePET

Subtle Medical, Inc.

SubtlePET is DICOM image-processing software that reduces noise in labeled FDG, amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA PET images for radiologist or...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2021-09-28
FDA-cleared K203182

SubtleMR

Subtle Medical, Inc.

SubtleMR is MRI image-processing software for reducing noise in supported head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI or increasing sharpness for...

Modality
MRI
Anatomy
Multi-region
Decision
2021-02-26
FDA-cleared K191688

SubtleMR

Subtle Medical, Inc.

SubtleMR is MRI image-processing software for enhancing supported MRI images within the exact submission workflow; the older submission's scanner, sequence, anatomy, and output...

Modality
MRI
Anatomy
Multi-region
Decision
2019-09-16
FDA-cleared K182336

SubtlePET

Subtle Medical, Inc.

SubtlePET V1.0.0 is image-processing software for transfer, storage, and noise reduction of FDG and amyloid PET images, including PET/CT and PET/MR studies.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole-body and brain PET imaging regions, including FDG and amyloid PET studies
Decision
2018-11-30