FDA.reportPublic FDA data

EBM

Primary DI
04719878879910
Brand
EBM
Company
EBM TECHNOLOGIES INCORPORATED
Model
SoliPACS™ Server
Published
2023-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LMBDevice, Digital Image Storage, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMBDevice, Digital Image Storage, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719878879910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719878879910047198788799104719878879910

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
657261272
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719878870108EBMUNISIGHT SYSTEM WITH UNIGATE2026-03-10
04719878879927EBMSoliPACS™ Web Viewer ,version 5.02023-06-09
04719878879934EBMSoliPACS™ Client Viewer, version 4.02023-06-09
04719878879941EBMSoliPACS™ Client Viewer with SoliPACS™ Gateway2023-06-09
04719878879958EBMEBM VS 10002023-06-09
04719878879965EBMMobiPACS™ App2023-06-09
04719878879972EBMSoliPACS™ Web Viewer ,version 8.02023-06-09
04719878879989EBMMobiPACS" App 1.2.1, Rad@2023-06-09
04719878879996EBMUniWeb 3602023-06-09
04719878870009EBMUNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.02026-03-10
04719878870122EBMUNIWEB2026-03-10
04719878870191EBMEBM IDO VIEWER2026-03-10
04719878870276EBMUNIWEB 8.02026-03-10
04719878870290EBMEBM IDO VIEWER 1.2.12026-03-10
04719878870016MedisanteBC800 3G2020-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850631008902Roentgen WorksBrit Systems, LLCLMB2026-08-27
00850631008896Roentgen WorksBrit Systems, LLCLMB2026-08-14
00850631008889Roentgen WorksBrit Systems, LLCLMB2026-08-13
00854810007229iCRco Clarity ViewerIcRco, Inc.LMB2026-07-22
00850631008872Roentgen WorksBrit Systems, LLCLMB2026-06-23
00850631008865Roentgen WorksBrit Systems, LLCLMB2026-06-05
04995047074816CuratOREIZO CORPORATIONLMB2026-05-29
00850631008858Roentgen WorksBrit Systems, LLCLMB2026-05-26
00745426000028MiPACS Storage ServerApryse Software Corp.LMB2026-04-27
00850631008834Roentgen WorksBrit Systems, LLCLMB2026-04-07
00850631008841Roentgen WorksBrit Systems, LLCLMB2026-04-07
00850631008827Roentgen WorksBrit Systems, LLCLMB2026-03-05
04907034602476UR-4MDTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2026-01-09
00850631008810Roentgen WorksBrit Systems, LLCLMB2026-01-01
00850631008803Roentgen WorksBrit Systems, LLCLMB2025-12-11
00850631008797Roentgen WorksBrit Systems, LLCLMB2025-11-20
00850631008766Roentgen WorksBrit Systems, LLCLMB2025-10-01
00857534006868IMRISmatrix 5.0IMRIS Imaging, Inc.LMB2025-09-18
00857534006875IMRISmatrix 5.0IMRIS Imaging, Inc.LMB2025-09-18
00850631008759Roentgen WorksBrit Systems, LLCLMB2025-08-14
00850631008742Roentgen WorksBrit Systems, LLCLMB2025-08-07
00850631008735Roentgen WorksBrit Systems, LLCLMB2025-07-31
04907034602155UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602162UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602230UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602247UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602254UR-NEXT4KSTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602261UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602278UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602285UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31