Vendor
10 FDA submission entries in this directory. This is not a count of distinct commercial offers.
Claim vendor profileEach entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.
Prepare with a buyer guide:
Clinical guide links appear when this list contains a current reviewed example. They do not classify or endorse the other entries. All buyer guides · Compare exact records · Documented families
Subtle Medical, Inc.
Authorized purpose: Process and enhance CT images from any CT scanner manufacturer or model as an adjunct to the original reconstructed image.
Subtle Medical, Inc.
PET image-processing software that reduces image noise while preserving the original images for clinical review.
Subtle Medical, Inc.
Authorized purpose: MRI image enhancement through noise reduction and sharpening for clinical image review.
Subtle Medical, Inc.
Authorized purpose: Enhance GBCA-enhanced brain MRI images to improve lesion and tissue contrast for radiologist review while preserving the original post-contrast image context.
Subtle Medical, Inc.
Authorized purpose: 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.
Subtle Medical Inc.
Authorized purpose: 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.
Subtle Medical, Inc.
SubtlePET is DICOM image-processing software that reduces noise in FDG, amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA PET images for radiologist or nuclear-medicine-physician review.
Subtle Medical, Inc.
Authorized purpose: 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 head MRI within the labeled workflow.
Subtle Medical, Inc.
Authorized purpose: 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 limits remain release-specific.
Subtle Medical, Inc.
Authorized purpose: 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.