AccessGUDID - DEVICE: VERITON CT (07290108670219)

GUDID

Device Identifier (DI) Information

Brand Name: VERITON CT
Version or Model: VERITON CT 364
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8010420-01
Company Name: SPECTRUM DYNAMICS MEDICAL, INC

Primary DI Number: 07290108670219
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078864620 *Terms of Use

Device Description: Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.

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?
45016	SPECT/CT system	An assembly of diagnostic devices that comprise a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine (NM) images, and a computed tomography (CT) camera system for x-ray images. The nuclear medicine images and the x-ray images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The SPECT and CT portions of the system may be used independently or in combination and the images may be transferred to other systems for radiation therapy planning or additional processing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPS	System, Tomography, Computed, Emission
JAK	System, X-Ray, Tomography, Computed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230600	000

Device Exempt from Premarket Submission: No 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: e80303d9-34a9-415d-a3ca-833d2f41f744
Public Version Date: June 09, 2023
Public Version Number: 1
DI Record Publish Date: June 01, 2023