Cleerly vs GE HealthCare AI Suite

GE HealthCare says it topped the FDA's AI authorization list in 2025 with 100 entries, a count from GE itself. The entries are separately cleared products built into GE scanners and ultrasound systems, with no single suite clearance. The ones closest to radiology are AIR Recon DL for MR (K213717, June 2022, with GE claiming scan times cut by up to 50%), Sonic DL (K243667, June 2025, extended to all anatomies and 7T) and Critical Care Suite for pneumothorax on chest X-ray (K223491, May 2023). icometrix, now part of GE, says its icobrain aria was cleared in November 2024 to detect ARIA on brain MRI.

Cleerly is one product, coronary CTA analysis, with six 510(k)s, an ischemia module and CPT code 75577 coverage. A hospital replacing MR scanners meets GE's reconstruction in the scanner line. A cardiac CT service adding plaque analysis meets Cleerly. Nobody picks between the two.