| Primary Device ID | B201CGSCENERGYTP0 |
| NIH Device Record Key | ea948d2e-1a6d-4a0c-abf7-6fbbfbc2b565 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clear Guide SCENERGY TP |
| Version Model Number | CGSCENERGYTP |
| Catalog Number | CG-SCENERGY-TP |
| Company DUNS | 965399905 |
| Company Name | CLEAR GUIDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| B201CGPAT0 - Clear Guide TP Access Tool | 2025-01-20 The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for ima |
| B201CGSCENERGYTP0 - Clear Guide SCENERGY TP | 2025-01-20The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR.
The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide Optical Head platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting, in patients of sufficient size (at least 25 kg). |
| B201CGSCENERGYTP0 - Clear Guide SCENERGY TP | 2025-01-20 The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and |
| B201CGSG0 - Clear Guide SteriGRID | 2025-01-20 The device is a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements d |
| B201CGTPF0 - Clear Guide TP Access Frame | 2025-01-20 The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for ima |
| B201CGTPP0 - Clear Guide TP Access Posts | 2025-01-20 The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for ima |
| B201CGCORE170 - Clear Guide CORE | 2022-10-17 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G |
| B201CGCORE240 - Clear Guide CORE | 2022-10-17 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G |
| B201CGOHM0 - Clear Guide Optical Head | 2022-10-17 The device is intended as an accessory hardware to provide input into medical device software by capturing video and other senso |