Torch
- Primary DI
- 00860010685402
- Brand
- Torch
- Company
- Voximetry, Inc.
- Model
- V1.2
- Published
- 2023-02-13
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| LLZ | System, Image Processing, Radiological |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LLZ | System, Image Processing, Radiological | Radiology | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K220630 | 000 | TorchTM Software | Voximetry, Incorporated | 2022-11-28 | LLZ |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00860010685402 | Primary | GS1 | 0 | |
Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.
Alternate GTIN / UPC / EAN Codes
| Source identifier | Source length | GTIN-14 normalized | Indicator | UPC-A | EAN-13 | Conversion note |
|---|
| 00860010685402 | 14 | 00860010685402 | 0 | 860010685402 | 0860010685402 | Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion. |
GMDN Terms
| Term | Definition |
|---|
| Nuclear medicine system workstation | A freestanding, multi-purpose, image processing device that can be a component of one or more nuclear medicine imaging systems, e.g., a gamma camera, PET system or 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. |
Regulatory Flags
- DUNS number
- 080208141
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices Sharing Product Codes