FDA UDI
In Commercial Distribution
🇺🇸 United States
VERITON CT
DI: 07290108670127
·
Model: VERITON CT 16
·
SPECTRUM DYNAMICS MEDICAL, INC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VERITON CT
- Primary DI
- 07290108670127
- Version / Model
- VERITON CT 16
- Catalog Number
- 8010172-01
- Company Name
- SPECTRUM DYNAMICS MEDICAL, INC
- Labeler DUNS
- 078864620
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-23
- Public Version
- 1
- Public Version Date
- 2020-07-01
- Public Version Status
- New
- Public Device Record Key
- dd641007-d07f-44c5-bee9-095515bc7db1
Device Description
Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
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
- No
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | Radiology | 892.1200 | 2 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | 892.1750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290108670127 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190457 | 000 |