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Clear Guide SCENERGY TP

FDA UDI

Class II (US FDA UDI)

by Clear Guide Medical

Identity

Trade Name
Clear Guide SCENERGY TP FDA UDI
Generic Name
Surgical planning/navigation-enhancement system FDA UDI
Device Name
The 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). FDA UDI
Model / Reference
CGSCENERGYTP FDA UDI
Description
The 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). FDA UDI

Identifiers

Catalog Number
CG-SCENERGY-TP FDA UDI
Primary DI / UDI-DI
B201CGSCENERGYTP0 FDA UDI
510(k) Number
K234030 FDA UDI
FDA Product Code
JAK FDA UDI
IYO FDA UDI
LLZ FDA UDI
ITX FDA UDI
GMDN Term
Surgical planning/navigation-enhancement system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1750 FDA UDI
892.1560 FDA UDI
892.2050 FDA UDI
892.1570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical planning/navigation-enhancement systemStereotactic system application software

Clear Guide SCENERGY TP by Clear Guide Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stereotactic system application software.

Cleared under the same submission

K234030 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clear Guide Medical

Sources (1)

  • FDA UDI ea948d2e-1a6d-4a0c-abf7-6fbbfbc2b565 36 fields · synced Jun 9, 2026