CLEAR GUIDE MEDICAL

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• clearguidemedical.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• Clear Guide SCENERGY

  2024-01-17

  Clear Guide Medical

• Clear Guide SCENERGY

  2020-09-30

  Clear Guide Medical

• Clear Guide SCENERGY

  2020-07-31

  Clear Guide Medical

• Clear Guide SCENERGY

  2017-12-08

  Clear Guide Medical

• Clear Guide SCENERGY

  2016-02-12

  CLEAR GUIDE MEDICAL

• CLEAR GUIDE ONE

  2014-09-19

  CLEAR GUIDE MEDICAL

GUDID#

• Clear Guide VisiMARKER Non-Sterile - The device is an accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.

  CLEAR GUIDE MEDICAL, INC.

  2022-10-04

• Clear Guide VisiMARKER II Non-Sterile - The device is an accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.

  CLEAR GUIDE MEDICAL, INC.

  2022-10-04

• Clear Guide VisiMARKER II - The device is an accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.

  CLEAR GUIDE MEDICAL, INC.

  2022-10-04

• Clear Guide CORE - The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.

  CLEAR GUIDE MEDICAL, INC.

  2022-10-06

• Clear Guide CORE - The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE13 model is a tablet PC with a 13" screen.

  CLEAR GUIDE MEDICAL, INC.

  2022-10-06

• Clear Guide Optical Head - The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.

  CLEAR GUIDE MEDICAL, INC.

  2022-10-07

• Clear Guide CORE - The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen.

  CLEAR GUIDE MEDICAL, INC.

  2022-10-07

• Clear Guide CORE - The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen.

  CLEAR GUIDE MEDICAL, INC.

  2022-10-07

• Clear Guide VisiMARKER - The device is an accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.

  CLEAR GUIDE MEDICAL, INC.

  2016-09-21

• Clear Guide TipTAG - The device is an accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.

  CLEAR GUIDE MEDICAL, INC.

  2017-04-07

• Clear Guide Optical Head - The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.

  CLEAR GUIDE MEDICAL, INC.

  2016-09-21

• Clear Guide SteriGRID - The device is a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is intended as a disposable accessory to Clear Guide TP Access Tool (CG-PAT)

  CLEAR GUIDE MEDICAL, INC.

  2026-05-11

• Clear Guide SteriGRID - The device is a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is intended as a disposable accessory to Clear Guide TP Access Tool (CG-PAT)

  CLEAR GUIDE MEDICAL, INC.

  2025-01-10

• Clear Guide TP Access Tool - The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting.

  CLEAR GUIDE MEDICAL, INC.

  2025-01-10

• Clear Guide TP Access Posts - The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device constitutes 3 pairs of posts (T, M, S) as a replacement for Clear Guide TP Access Tool (CG-PAT).

  CLEAR GUIDE MEDICAL, INC.

  2025-01-10

• Clear Guide TP Access Frame - The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is a guide frame replacement for the Clear Guide TP Access Tool (CG-PAT).

  CLEAR GUIDE MEDICAL, INC.

  2025-01-10

• Clear Guide SCENERGY TP - 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).

  CLEAR GUIDE MEDICAL, INC.

  2025-01-10

• Clear Guide SteriMASK - The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. Device is packaged together with one sterile gel packet.

  CLEAR GUIDE MEDICAL, INC.

  2022-10-03

• Clear Guide SteriMASK - The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.

  CLEAR GUIDE MEDICAL, INC.

  2016-09-21

• Clear Guide SCENERGY - CGSCENERGY

  CLEAR GUIDE MEDICAL, INC.

  2016-09-21

• Clear Guide SCENERGY - CGSCENERGY

  CLEAR GUIDE MEDICAL, INC.

  2016-09-21

• Clear Guide ONE - CGONE

  CLEAR GUIDE MEDICAL, INC.

  2016-09-21

• Clear Guide Optical Head - CGOH

  CLEAR GUIDE MEDICAL, INC.

  2016-09-21

• Clear Guide ONE - CGONE

  CLEAR GUIDE MEDICAL, INC.

  2016-09-21

• Clear Guide SteriMASK - CGSM

  CLEAR GUIDE MEDICAL, INC.

  2016-09-21

• Clear Guide VisiMARKER - CGVM

  CLEAR GUIDE MEDICAL, INC.

  2016-09-21

• Clear Guide TipTAG - CGTT

  CLEAR GUIDE MEDICAL, INC.

  2017-04-07