AccessGUDID - DEVICE: Symbia Pro.specta X7 (04056869264769)

GUDID

Device Identifier (DI) Information

Brand Name: Symbia Pro.specta X7
Version or Model: 11364753
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SIEMENS MEDICAL SOLUTIONS USA, INC.

Primary DI Number: 04056869264769
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 868230876 *Terms of Use

Device Description: No description.

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210557	000
K212604	000
K231102	000
K243186	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: 1e9625bb-4818-42ed-88c2-0c1df0d93fc4
Public Version Date: February 19, 2025
Public Version Number: 4
DI Record Publish Date: February 21, 2022