FDA.report

Patient Data Manager

Primary DI
04056481140502
Company
Brainlab AG
Model
2.5
Published
2018-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
314482980
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
04056481140502PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
04056481140502PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
LMADigitizer, Image, Radiological2Radiology892.2030NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

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04056481146672Mixed Reality Spine Navigation1.12025-07-31
04056481145941Disposable Loop-X Source Drape (1 Pc)22183-122025-07-25
04056481145934Disposable Loop-X Detector Drape (1 Pc)22183-132025-07-24
04056481145330CRANIAL 4PI HEADREST PLATFORM434422025-06-26
04056481145347CRANIAL 4PI HEAD SUPPORT STANDARD434492025-06-26
04056481145354CRANIAL 4PI STEREOTACTIC MASK 3.2MM (5 PCS.)434542025-06-26
04056481145361CRANIAL 4PI WEDGE 10 DEG.434552025-06-26
04056481145378CRANIAL 4PI SPACER 20MM434562025-06-26
04056481145453CRANIAL 4PI INDEXING PLATE434572025-06-26
04056481145460CRANIAL 4PI HEAD SUPPORT WIDE434602025-06-26
04056481145477CRANIAL 4PI STEREOTACTIC MASK 3.2MM (1 PC.)43454-012025-06-26
04056481145484CRANIAL 4PI WEDGE 5 DEG.434582025-06-26
04056481145873Image Fusion5.02025-06-26
04056481145880Contouring5.02025-06-26
04056481145897Fibertracking3.02025-06-26
04056481146030RT Elements 4.52025-06-25
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S558242025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L558252025-06-17

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00850677007020MDR VideoHYLAND LLCLMA2016-09-16
00850677007037Dicom BoxHYLAND LLCLMA2016-09-16
04056481006662Origin Data Management / Patient Data ManagerBrainlab AGLMA2016-09-15