FDA.reportPublic FDA data

EM Probe Bracket Kit, C1-6, Single

Primary DI
00860006066345
Brand
EM Probe Bracket Kit, C1-6, Single
Company
Mediview Xr, Inc.
Model
SPEC-0551
Catalog number
XR90-PBRK-C16-01
Device description
Single ultrasound probe bracket for use with GE C1-6-D transducers.
Published
2025-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223125000XR90 (XR90-SYS)Mediview Xr, Inc.2023-07-13LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860006066342PackageGS18In Commercial Distribution
00860006066345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000606634210860006066342
00860006066345008600060663458600060663450860006066345

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system tracking positioner, single-useA metal or plastic bracket intended to be applied to a hand-held ultrasound (US) transducer for the repeatable positioning (detach from/reattach to same place) of an electromagnetic (EM) sensor and/or needle guide on the transducer. It may be used in conjunction with an EM device tracking system and is intended for applications involving needle guidance and tracking such as ablation, core tissue biopsy, fluid aspiration, therapeutic delivery and vascular access. Disposable needle guides and imaging-supportive devices (e.g., US transducer cover/gel) may be included with the positioner; the transducer and sensor are not included. This is a single-use device.

Regulatory Flags#

DUNS number
117407269
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044606016Registration Marker Kit, Sterile, SingleSPEC-03032023-10-23
00850044606030Kit, Aurora FG Mounting Brackets, LTXR90-BRK-FG-LT2023-10-23
00850044606047Kit, Aurora FG Mounting Brackets, RTXR90-BRK-FG-RT2023-10-23
10860006066342EM Probe Bracket Kit, C1-6, SingleSPEC-0551XR90-PBRK-C16-012025-01-02
00860006066369XR90 System, LOGIQXR90-SYS-LOGIQ2025-01-02
00860006066376XR90 System, LOGIQ, Single HeadsetXR90-LQ-HMD012025-01-02
00860006066383XR90 System, LOGIQ, Upgrade KitXR90-LQ-UPGRADE2025-01-02
00850044606023EM Probe Bracket Kit, C1-5, SingleSPEC-0310XR90-PBRK-C15-012023-10-23
00850044606054XR90XR90-SYS2023-10-23
00850044606061OmnifyXROXR-SYS2023-11-01
00850044606009Triangle Template KitXR90-CT-KIT2023-10-24
10850044606013Registration Marker Kit, Sterile, SingleSPEC-03032023-10-23
00860006066307MediScout systemMS-100-10012021-04-20

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