AccessGUDID - DEVICE: Standard Imaging Lucy 3D QA Phantom (00850019946505)

GUDID

Device Identifier (DI) Information

Brand Name: Standard Imaging Lucy 3D QA Phantom
Version or Model: 91210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 91210
Company Name: STANDARD IMAGING INC.

Primary DI Number: 00850019946505
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788084705 *Terms of Use

Device Description: Standard Imaging Lucy 3D QA Phantom is designed to perform comprehensive quality assurance tests for an entire stereotactic radiosurgery/SRT procedure. The phantom allows verification of treatment planning software calculations for volume measurements, distance measurements, image fusion and image transfer. Dosimetry verification is accomplished via components that accommodate ion chambers, film, MOSFETs, TLDs and polymer gels.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40631	Multi-modality therapeutic radiation phantom, test object	A device consisting of a variety of multi-modality radiation therapy phantom designs. It can consist of an object of uniform material density or a two or three-dimensional (3-D) model containing patterns of objects, materials, or openings. It is available in both fixed and variable configurations including holders for ionization chambers, dosimeters or other radiation measurement instruments. It is a quality assurance (QA) device used in the calibration of photon and electron beam emitting radiation therapy systems and the measurement of performance attributes, e.g., beam flatness, symmetry, dose depth or geometric accuracy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXG	Phantom, Anthropomorphic, Radiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fa496635-8537-4d66-b977-73068d890f0b
Public Version Date: June 30, 2023
Public Version Number: 1
DI Record Publish Date: June 22, 2023