FDA.reportPublic FDA data

Origin Data Management / Patient Data Manager

Primary DI
04056481132453
Brand
Origin Data Management / Patient Data Manager
Company
Brainlab SE
Model
2.3.1
Catalog number
25100-12A
Published
2017-01-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LMADigitizer, Image, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMADigitizer, Image, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481132453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481132453040564811324534056481132453

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system workstationA freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314482980
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481145804Brainlab Origin OR1.02026-08-21
04056481006525Em Disposable Stylet18097180972018-02-08
04056481141141Disposable Pre-calibrated Suction Charr. 1252185-012021-03-08
04056481145200DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS)549292023-10-17
04056481146702Curve Navigation177022025-10-13
04056481146429Automatic Regsitration2.72026-02-20
04056481146054Patient Reference Rod-Clamp Spine & Trauma558262025-09-19
04056481145613Vascular Navigation PAD2.02025-09-11
04056481146672Mixed Reality Spine Navigation1.12025-07-31
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S558242025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L558252025-06-17
04056481146320Alignment Software Spine2.12025-06-16
04056481145828Microscope Navigation1.72025-06-11
04056481143985Mixed Reality Spine Navigation1.02025-05-31
04056481145620Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm564162025-02-24
04056481145637Alignment Guide Tube Cranial 4.9 mm / 8.0 mm564172025-02-24
04056481145903Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm564182025-02-24
04056481146047Cirq Robotic Tracking Array 10.056302A2025-02-24
04056481146337Alignment Software Cranial with LITT2.12025-02-24
04056481145514Z-touch Laser Registration Pointer18370-10A2025-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854810007045CHROMEIcRco, Inc.LMA2026-07-22
008548100070763600IcRco, Inc.LMA2026-07-22
00854810007113iDRIcRco, Inc.LMA2026-07-22
008548100072123600IcRco, Inc.LMA2026-07-22
04056481140502Patient Data ManagerBrainlab SELMA2018-06-15
04056481138615PATIENT DATA MANAGER 2.4 INSTALLERBrainlab SELMA2018-02-09
00850677007082MDR Video TouchHYLAND LLCLMA2016-09-26
00851194002000Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002017Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002031Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002048Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002093Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002109Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002116Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002123Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002130Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002147Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00866389000167Radlink Laser Pro 16RADLINK, INC.LMA2016-09-21
00850677007068MDR Video CartHYLAND LLCLMA2016-09-19
00850677007075MDR Video SpeechHYLAND LLCLMA2016-09-19
00850677007020MDR VideoHYLAND LLCLMA2016-09-16
00850677007037Dicom BoxHYLAND LLCLMA2016-09-16
04056481006662Origin Data Management / Patient Data ManagerBrainlab SELMA2016-09-15