Standard Imaging RAy Software 91336

GUDID 00866562000274

Standard Imaging RAy Software is a film dosimetry application, designed to perform one-dimensional, two-dimensional, and three-dimensional analyses of dose deposition pattern on film under specific mega-voltage irradiation setups.

STANDARD IMAGING INC.

Radiation therapy software
Primary Device ID00866562000274
NIH Device Record Key8a4278b5-e0f1-4fc1-9554-d56b060f2d4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameStandard Imaging RAy Software
Version Model Number91336
Catalog Number91336
Company DUNS788084705
Company NameSTANDARD IMAGING INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100866562000274 [Primary]

FDA Product Code

MWWAccessory - Film Dosimetry System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-30
Device Publish Date2023-06-22

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