Subtle Medical, Inc.

Address:883 Santa Cruz Avenue,Menlo Park,CA,94025,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (2) System, Tomography, Computed, Emission (KPS) (1)

Premarket Exempt

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SubtlePET - 00860000171205 Catalog Number :

Device Description : SubtlePET is an image processing software intended for use by radiologists and n SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (FDG), amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA radiotracer PET images (including PET/CT and PET/MRI).

Device Class : 2

Duns Number: 081069974

Premarket Exempt : No

Product Code : LLZ, KPS

Prescription Use : Yes

Device Count : 1

SubtleMR - 00860000171212 Catalog Number :

Device Description : SubtleMR is an image processing software that can be used for image enhancement SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal regions of the body, or increase image sharpness for head MRI.

Device Class : 2

Duns Number: 081069974

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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