FDA UDI In Commercial Distribution 🇺🇸 United States

Standard Imaging DoseView 3D

DI: 00866562000205 · Model: 92260 · STANDARD IMAGING INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Standard Imaging DoseView 3D
Primary DI
00866562000205
Version / Model
92260
Catalog Number
92260
Company Name
STANDARD IMAGING INC.
Labeler DUNS
788084705
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-11
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
39dd0e81-38ba-4daf-9c48-d562346c3d7e

Device Description

Standard Imaging DoseView 3D is a medical device intended for performing water phantom based commissioning and QA measurements on radiation therapy systems.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IYE Accelerator, Linear, Medical

GMDN Terms

Code Name
38399 Accelerator system quality assurance device

Identifiers

Type ID
Primary 00866562000205