AccessGUDID - DEVICE: D-SPECT Refurbished (07290108670097)

GUDID

Device Identifier (DI) Information

Brand Name: D-SPECT Refurbished
Version or Model: 002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8010517-01
Company Name: SPECTRUM DYNAMICS MEDICAL, INC

Primary DI Number: 07290108670097
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078864620 *Terms of Use

Device Description: The D-SPECT® system is a single photon emission computing tomography system (SPECT) intended for detection of radioisotope tracer uptake in the patient’s body and to produce cross-sectional images through computer reconstruction of the data.

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?
40643	SPECT system, annular detector array	An assembly of devices comprising a diagnostic, stationary, single photon emission computed tomography (SPECT) system designed exclusively for use in tomographic imaging applications. It detects, records, quantifies and analyses radionuclide emissions produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. The gantry position is fixed and the imaging table/chair moves/rotates under computer or manual control. Its imaging capabilities include static and dynamic imaging applications and three-dimensional (3-D) digital image reconstruction/display at any angle including axial, coronal and sagittal planes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPS	System, Tomography, Computed, Emission

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161740	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
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 352a24fd-e7d9-40e8-b06b-6382b6305c07
Public Version Date: July 08, 2025
Public Version Number: 1
DI Record Publish Date: June 30, 2025