FDA.reportPublic FDA data

Ray

Primary DI
00866498000300
Brand
Ray
Company
AGILE RADIOLOGICAL TECHNOLOGIES
Model
5.0
Catalog number
Ray 5.0
Device description
The Radiation Analyzer (RAy)is a film dosimetry application used to verify complex radiation therapy treatment plans.
Published
2017-10-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWWAccessory - Film Dosimetry System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWWAccessory - Film Dosimetry SystemRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866498000300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866498000300008664980003008664980003000866498000300

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5139859877ray_support@technosoft.com

Regulatory Flags#

DUNS number
014019706
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B9876X00Radiochromic.comRADIOCHROMIC SL.MWW2025-12-09
00810106410845FilmQA ProASHLAND SPECIALTY INGREDIENTS G.P.MWW2025-02-12
B9875X10Radiochromic.comRADIOCHROMIC SL.MWW2024-06-10
B9875X00Radiochromic.comRADIOCHROMIC SL.MWW2023-12-10
00866562000274Standard Imaging RAy SoftwareSTANDARD IMAGING INC.MWW2023-06-22
04042761006897OlympusOLYMPUS Winter & Ibe GmbHMWW2023-01-27
B9874X00Radiochromic.comRADIOCHROMIC SL.MWW2022-04-08
00850000065000FilmQA ProASHLAND SPECIALTY INGREDIENTS G.P.MWW2021-09-23
B9873X40Radiochromic.comRADIOCHROMIC SL.MWW2021-09-11
B9873X30Radiochromic.comRADIOCHROMIC SL.MWW2020-10-21
EIBAE60200100MatriXX PT kalibriertIBA Dosimetry GmbHMWW2016-09-09
EIBAM10136410DigiPhant IBA Dosimetry GmbHMWW2016-09-09