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FDA-cleared K243933

Ceevra Reveal 3+

Ceevra, Inc.

Authorized purpose: CT and MR 3D segmentation, measurements and interactive models for adult preoperative and intraoperative surgical planning; not primary diagnosis.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region
Decision
2025-03-04
FDA-cleared K233568

Ceevra Reveal 3+

Ceevra, Inc.

Authorized purpose: Process, review, analyze, communicate, and exchange multidimensional CT or MR images, including preliminary segmentation of normal anatomy, for preoperative surgical planning and intraoperative display; healthcare professionals make all final patient-management decisions. Machine-learning algorithms are for adults aged 22 years and older, while images for patients under 22 or of unknown age are generated without machine learning.

Modality
CT/CTA; MRI
Anatomy
Multi-region normal anatomy represented in CT or MR images; validated examples include prostate, bladder, neurovascular bundles, kidney, artery, and vein
Decision
2023-12-05
FDA-cleared K222676

Ceevra Reveal 3

Ceevra, Inc.

Authorized purpose: Ceevra Reveal 3 processes, reviews, analyzes, communicates, and interchanges multidimensional CT and MR images for preoperative planning and intraoperative display, with preliminary machine-learning segmentations of selected normal anatomy for adult patients aged 22 years and older.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific anatomy represented in CT or MR; normal anatomy used by supported segmentation models
Decision
2023-04-25