FDA.report

Centralite Patient Positioning Laser

Primary DI
B237MLC30
Brand
Centralite Patient Positioning Laser
Company
DIACOR, INC.
Model
MLC-3
Device description
Three Moving Laser Controller
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IWEMonitor, Patient Position, Light-Beam

Product Code Classifications

CodeDeviceSpecialtyClass
IWEMonitor, Patient Position, Light-BeamRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B237MLC30PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
605813559
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
true
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 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
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
B237ZEP50Zephyr Patient Positioning and Transfer SystemZEP-52025-03-27
B237ZTGACA020Zephyr Patient StretcherZTG-ACA-022025-03-27
B237ZBLABF010Zephyr Patient Positioning and Transfer SystemZBL-ABF-012023-06-12
B237ZBLAWP010Zephyr Patient Positioning and Transfer SystemZBL-AWP-012023-06-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06977071936009MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2024-06-21
00840348500097AADCOAADCO MEDICAL, INC.IWE2022-12-07
00840348500103RayshieldAADCO MEDICAL, INC.IWE2022-12-07
00840348500110AADCOAADCO MEDICAL, INC.IWE2022-12-07
B365113440Port Film Graticule, Latch Mount, Elekta CompatibleAktina Corp.IWE2021-05-21
B365113450Port Film Graticule, Tray Mount, Elekta CompatibleAktina Corp.IWE2021-05-21
B365113460Open Air Graticule, 2cm, Elekta CompatibleAktina Corp.IWE2021-05-21
B36511346C10Graticule, PTW David MountAktina Corp.IWE2021-05-21
B36511346M10Open Air Graticule, 1cm, Elekta CompatibleAktina Corp.IWE2021-05-21
B365540440Port Film Graticule, Siemens CompatibleAktina Corp.IWE2021-05-21
B365540450GRADIC Port Film Graticule, Siemens CompatibleAktina Corp.IWE2021-05-21
B365542240Cross-Hair Reticule, Radiation OpaqueAktina Corp.IWE2021-05-21
B365542250Cross-Hair Reticule, XRETICAktina Corp.IWE2021-05-21
B365542270Cross-Hair Reticule, Open-AirAktina Corp.IWE2021-05-21
B365548830Simulator Dot Reticle SetAktina Corp.IWE2021-05-21
04260590370761CARINAL A P GMBH LASER APPLIKATIONENIWE2021-04-01
04260590370778CARINAL A P GMBH LASER APPLIKATIONENIWE2021-04-01
00850077007255Huestis Centralite Patient Positioning LaserHUESTIS MACHINE CORPORATIONIWE2021-02-18
00850077007262Huestis Centralite Patient Positioning LaserHUESTIS MACHINE CORPORATIONIWE2021-02-18
00850077007217Huestis Centralite Patient Positioning LaserHUESTIS MACHINE CORPORATIONIWE2021-02-04
00850077007224Huestis Centralite Patient Positioning LaserHUESTIS MACHINE CORPORATIONIWE2021-02-04
00850077007231Huestis Centralite Patient Positioning LaserHUESTIS MACHINE CORPORATIONIWE2021-02-04
00850077007248Huestis Centralite Patient Positioning LaserHUESTIS MACHINE CORPORATIONIWE2021-02-04
B136MLB1500Sun Nuclear MICROGAMMEX, INC.IWE2021-01-25
B136MLB2000Sun Nuclear MICROGAMMEX, INC.IWE2021-01-25
B136MLB3000Sun Nuclear MICRO+GAMMEX, INC.IWE2021-01-25
B136MLB300MR0Sun Nuclear MICRO+ MRGAMMEX, INC.IWE2021-01-25
B136MLB3500Sun Nuclear MICRO+GAMMEX, INC.IWE2021-01-25
B136MLB350MR0Sun Nuclear MICRO+ MRGAMMEX, INC.IWE2021-01-25
B136MLG1500Sun Nuclear MICROGAMMEX, INC.IWE2021-01-25