FDA UDI In Commercial Distribution 🇺🇸 United States

Standard Imaging IMRT Dose Verification Phantom

DI: 00850019946550 · Model: 91230 · STANDARD IMAGING INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Standard Imaging IMRT Dose Verification Phantom
Primary DI
00850019946550
Version / Model
91230
Catalog Number
91230
Company Name
STANDARD IMAGING INC.
Labeler DUNS
788084705
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-22
Public Version
1
Public Version Date
2023-06-30
Public Version Status
New
Public Device Record Key
cf3d9a03-250d-4c22-a29d-b0e6cbc16ec6

Device Description

Standard Imaging IMRT Phantoms are designed to provide feedback on complex treatment plans generated using 3D. The phantoms are designed to mimic a human torso. Both film and ion chambers can be simultaneously irradiated for comparisons with the treatment planning system.

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
Yes
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
IXG Phantom, Anthropomorphic, Radiographic

GMDN Terms

Code Name
40631 Multi-modality therapeutic radiation phantom, test object

Identifiers

Type ID
Primary 00850019946550