Turn this list into an evaluation

Each 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

FDA-cleared K241350

Clarify DL

GE Medical Systems Israel, Functional Imaging

Authorized purpose: Clarify DL is a deep-learning reconstruction function intended to reduce noise and improve image quality of nuclear-medicine bone SPECT scintigraphy for all ages on the supported Xeleris V and StarGuide platforms.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Bone
Decision
2025-01-03
FDA-cleared K241665

Omni Legend

GE Medical Systems Israel, Functional Imaging

Omni Legend is a PET/CT system for attenuation-corrected PET with positron-emitting radiopharmaceuticals across whole-body, head, heart, brain, lung, breast, bone, gastrointestinal, lymphatic, and other organ workflows; CT can be used for diagnosis, planning, and image fusion.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2024-08-08