FDA.reportPublic FDA data

Centralite Patient Positioning Laser

Primary DI
B237MLK30
Brand
Centralite Patient Positioning Laser
Company
Diacor, Inc.
Model
MLK-3
Device description
CML Wall Mount Kit
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IWEMonitor, Patient Position, Light-Beam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWEMonitor, Patient Position, Light-BeamRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B237MLK30PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laser patient positioning systemA fixed or variable focal distance lasing device assembly designed to project a harmless beam (light pattern) onto a patient's skin or other alignment device. It is typically used to position and/or monitor the position of a patient during diagnostic imaging, radiation therapy, or radiation therapy treatment planning or simulation procedures. A set of these assemblies is used to enable precise and reproducible 1, 2, or multi-dimensional alignment of a selected portion(s) of the patient's anatomy with respect to a radiation beam(s) used during diagnostic or therapeutic procedures. It typically includes a light source, mechanical/electronic controls, and associated mounting devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
605813559
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B237ZEPACR110Zephyr Patient Positioning and Transfer SystemZEP-ACR-112025-12-23
B237ZCPAST100Zephyr Patient Positioning and Transfer SystemZCP-AST-102025-11-13
B237ZEPAUB800Zephyr Patient Positioning and Transfer SystemZEP-AUB-802025-09-26
B237ZEPATG030Zephyr Patient Positioning and Transfer SystemZEP-ATG-032025-08-13
B237ZEPAFR200Zephyr Patient Positioning and Transfer SystemZEP-AFR-202023-06-12
B237ZBL25000Zephyr Patient Positioning and Transfer SystemZBL-2-5002024-07-11
B237ZEPAPS100Zephyr Patient Positioning and Transfer SystemZEP-APS-102024-07-11
B237ZEPAPS110Zephyr Patient Positioning and Transfer SystemZEP-APS-112024-07-11
B237ZEPAPS120Zephyr Patient Positioning and Transfer SystemZEP-APS-122024-07-11
B237ZEPAPS500Zephyr Patient Positioning and Transfer SystemZEP-APS-502024-07-11
B237ZEPASC010Zephyr Patient Positioning and Transfer SystemZEP-ASC-012024-07-11
B237ZEPASC100Zephyr Patient Positioning and Transfer SystemZEP-ASC-102024-07-11
B237ZEPASC500Zephyr Patient Positioning and Transfer SystemZEP-ASC-502024-07-11
B237ZXLACA100Zephyr Patient Positioning and Transfer SystemZXL-ACA-102024-07-11
B237ZXLACI150Zephyr Patient Positioning and Transfer SystemZXL-ACI-152024-07-11
B237ZXLACI160Zephyr Patient Positioning and Transfer SystemZXL-ACI-162024-07-11
B237ZXLADK040Zephyr Patient Positioning and Transfer SystemZXL-ADK-042024-07-11
B237ZBLABF010Zephyr Patient Positioning and Transfer SystemZBL-ABF-012023-06-12
B237ZBLAWP010Zephyr Patient Positioning and Transfer SystemZBL-AWP-012023-06-12
B237ZBLHIN100Zephyr Patient Positioning and Transfer SystemZBL-HIN-102023-06-12

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Primary DI, Brand, Company table
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