AiMIFY (1.x)
Subtle Medical, Inc.
Subtle Medical Inc
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015425142 | 3015425142 | Subtle Medical Inc | 1 | N | 2026-01-01 | 883 Santa Cruz Avenue Suite 205 Menlo Park CA US 94025 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 228281 | 1145253911 | K243250 | SubtleHD (1.x) | QIH | 2025-02-12 |
| 228281 | 1592523761 | K241329 | SubtleSYNTH (1.x) | QIH | 2024-07-11 |
| 228281 | 1257750733 | K240290 | AiMIFY (1.x) | LLZ | 2024-08-21 |
| 228281 | 1622850440 | K233699 | SubtleREFORMAT (1.x) | LLZ | 2024-04-29 |
| 228281 | 1433169145 | K223623 | SubtleMR (2.3.x) | LLZ | 2023-05-11 |
| 228281 | 1468812412 | K211964 | SubtlePET | KPS | 2021-09-28 |
| 228281 | 1655609590 | K203182 | SubtleMR | LLZ | 2021-02-26 |
| 228281 | 1866035596 | K191688 | SubtleMR | LLZ | 2019-09-16 |
| 228281 | 1743446514 | K182336 | SubtlePET | KPS | 2018-11-30 |
Product Codes Associated With Registrations
PMN
SubtleSYNTH (1.x)
Subtle Medical, Inc.
SubtleREFORMAT (1.x)
Subtle Medical, Inc.
SubtleMR (2.3.x)
Subtle Medical, Inc.
SubtlePET
Subtle Medical, Inc.
SubtleMR
Subtle Medical, Inc.
SubtleMR
Subtle Medical, Inc.
SubtlePET
Subtle Medical, Inc.
GUDID
SubtleMR - 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.
2022-04-29
SubtlePET - 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).
2022-04-29