Ceevra, Inc.

Ceevra, Inc. specializes in image segmentation application software, which automates the identification and delineation of anatomical structures in medical imaging scans (such as MRI or CT). Their devices, like Reveal 2.0 and Clarity Reveal, assist radiologists and clinicians by streamlining diagnostic workflows. These tools are designed to enhance precision in medical imaging analysis rather than replace physical hardware.

Ceevra, Inc. is headquartered in the United States, which means its devices are primarily regulated under US FDA guidelines (e.g., 510(k) clearances and UDI listings). However, their software is also classified as Class II or Class IIa in the EU, requiring compliance with EUDAMED for market access in Europe. The company’s US base influences its primary regulatory pathway, though its EU-classified devices must still meet EU standards for distribution there.

Ceevra’s devices appear in EUDAMED (for EU market listings), FDA’s 510(k) database (for US pre-market clearances), and the FDA’s UDI system (for device identification). These registries reflect their regulatory status: EUDAMED tracks devices authorized in the EU under Class II/IIa, while FDA records document US clearance pathways. The UDI system ensures traceability for both markets, linking devices to their regulatory approvals.

Ceevra’s image segmentation software is classified as Class II or Class IIa in both the US and EU. This classification indicates moderate risk—higher than Class I (low risk) but lower than Class III (high risk). It requires pre-market submission (e.g., FDA 510(k) or EU conformity assessment) to demonstrate safety and performance before commercialization. The classification ensures these tools undergo rigorous validation to support clinical decision-making without posing undue risk.