FDA UDI
In Commercial Distribution
🇺🇸 United States
PET-CT SCANNER
DI: 04987670103810
·
Model: PCD-1000A
·
CANON MEDICAL SYSTEMS CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PET-CT SCANNER
- Primary DI
- 04987670103810
- Version / Model
- PCD-1000A
- Company Name
- CANON MEDICAL SYSTEMS CORPORATION
- Labeler DUNS
- 690575113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-14
- Public Version
- 1
- Public Version Date
- 2021-12-22
- Public Version Status
- New
- Public Device Record Key
- a4c6fff4-8314-4016-90d1-105b489a7cc3
Device Description
This device is used to acquire transaxial images of any desired region of the body, providing a wide range of diagnostic capabilities.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | Radiology | 892.1750 | 2 |
| KPS | System, Tomography, Computed, Emission | Radiology | 892.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45143 | PET/CT system | A diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) 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 PET and CT portions of the system may be used independently or in combination. The PET and CT 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 | 04987670103810 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203314 | 000 |