FDA.reportPublic FDA data

WebPAX®

Primary DI
B127WP90
Brand
WebPAX®
Company
HEART IMAGING TECHNOLOGIES, LLC
Model
9
Catalog number
n/a
Device description
WebPAX® is intended for use in the communication and storage of medical images. WebPAX® is alsointended for use as a comprehensive solution to view, optimize, and post-process diagnostic medicalimages as an aid to physicians and other healthcare professionals in the evaluation of digital imagingexaminations.
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K152949000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152949000WebPAXHeart Imaging Technologies, LLC2016-08-17LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B127WP90PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical image management systemA computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
194348913
Device count
1
Lot or batch
true
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351235TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351341TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVLLZ2026-10-22
05420060351365TRUMATCHMaterialise NVLLZ2026-10-22
05420060351372TRUMATCHMaterialise NVLLZ2026-10-22
05420060351389TRUMATCHMaterialise NVLLZ2026-10-22
05420060351396TRUMATCHMaterialise NVLLZ2026-10-22
05420060351402TRUMATCHMaterialise NVLLZ2026-10-22
B621ICOBRAINCTP1X7Y0icobrain ctpicometrix NVLLZ2026-10-22
00850631008919Roentgen WorksBrit Systems, LLCLLZ2026-10-21
00850631008926Roentgen WorksBrit Systems, LLCLLZ2026-10-21
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20