Ziostation
- Primary DI
- B131ZIOE1001SYS0
- Company
- QI IMAGING LLC
- Model
- 2.4.3.1
- Catalog number
- ZIOE1001SYS
- Device description
- A self-standing software program that adds specific image processing and/or analysis capabilities to radiological DICOM image data.
- Published
- 2017-02-12
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Regulatory Flags
- DUNS number
- 606828924
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- 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
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B131ZIOE1001SYS0 | Primary | HIBCC | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| B131ZIOE1001SYS0 | Primary | HIBCC | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| LLZ | System, Image Processing, Radiological | 2 | Radiology | 892.2050 | N | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|
| Radiology DICOM image processing application software | A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays). |
Device Sizes
No records found.
Storage And Handling
No records found.
Contacts
No records found.
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| B131ZIOE1001SYS0P | Ziostation | 2.4.3.1 | ZIOE1001SYS | 2017-02-12 |
Other Devices Sharing Product Codes