FDA UDI
In Commercial Distribution
🇺🇸 United States
TruSPECT
DI: 07290108670233
·
Model: STANDALONE PROCESSING STATION
·
SPECTRUM DYNAMICS MEDICAL, INC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TruSPECT
- Primary DI
- 07290108670233
- Version / Model
- STANDALONE PROCESSING STATION
- Catalog Number
- 8010290-01
- Company Name
- SPECTRUM DYNAMICS MEDICAL, INC
- Labeler DUNS
- 078864620
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-26
- Public Version
- 1
- Public Version Date
- 2023-01-03
- Public Version Status
- New
- Public Device Record Key
- bc932888-45b4-40ff-bbde-81ccf60b5f41
Device Description
TruSPECT Radiological Image Processing Station
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 |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
| QIH | Automated Radiological Image Processing Software | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40934 | SPECT system workstation | A freestanding, image processing device that is a component of single photon emission computed tomography (SPECT) system. It is sometimes considered to be a component to a picture archiving and communication system (PACS). It does not contain the controls for the direct operation of the diagnostic imaging system. It can receive and transmit data both on-line and off-line and is typically located at a site remote from the operator's console. It has the capability to further process, manipulate and/or view patient images and information collected from one or more nuclear medicine based imaging systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290108670233 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212230 | 000 |