CLEAR GUIDE MEDICAL

FDA Device Registration & Listing · Baltimore, MD, US · Registration 3011396687

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011396687
FEI Number
3011396687
Entity Name
CLEAR GUIDE MEDICAL
City/State/Country
Baltimore, MD, US
Establishment Address
3600 Clipper Mill Rd Ste 400, Baltimore, MD 21211, US
Establishment Type(s)
Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Clear Guide Medical (Owner Number: 10048333)
Owner / Operator Contact Address
3600 Clipper Mill Road, Suite 400, Baltimore, MD 21211, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SCENERGY Clear Guide VisiMARKER Clear Guide TipTAG Clear Guide VisiMARKER II Clear Guide ONE SCENERGY Clear Guide SCENERGY VisiTIP B-Bevel Needle (VT1820B) VisiTIP B-Bevel Needle (VT2010B) SteriMASK

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-10-08
JAC System, X-Ray, Film Marking, Radiographic Radiology Class 1 892.1640 2016-03-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2014-12-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2019-11-08
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2016-03-09
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-07-20
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2019-11-08

Official Correspondent

Patrick Duke

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Clear Guide Medical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243523 Siemens Medical Solutions USA, Inc. NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime 2025-02-12
K781431 General Electric Co. ELECTRIC CT/T OPERATOR DISPLAY CONSOLE 1978-09-07
K231574 FUJIFILM Healthcare Americas Corporation Scenaria View 4.2 2023-10-12
K233583 FUJIFILM Healthcare Americas Corporation FCT iSTREAM Phase 1 2024-04-26
K151376 Covidien, LLC superDimension Navigation System 2015-11-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2011 GE Medical Systems, LLC 2
HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017 Philips Medical Systems 2
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017 Philips Medical Systems 2
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017 Philips Medical Systems 2
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017 Philips Medical Systems 2
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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2134213 CANON MEDICAL INFORMATICS, INC. MINNETONKA, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011396687. Last updated year: 2026. Please use registration number 3011396687 when referencing this establishment in official correspondence.
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