FDA UDI
In Commercial Distribution
🇺🇸 United States
Prism Flow
DI: B358PCI01PF0
·
Model: 4.1
·
PRISM CLINICAL IMAGING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Prism Flow
- Primary DI
- B358PCI01PF0
- Version / Model
- 4.1
- Catalog Number
- PCI01PF
- Company Name
- PRISM CLINICAL IMAGING, INC.
- Labeler DUNS
- 190899638
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-08
- Public Version
- 2
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- 4d550874-192a-4241-9d31-73e446c847bd
Device Description
Prism Flow® is the DICOM communications and storage and Prism workflow manager. It provides integrated access, application configuration, and audit logging across physical locations and the cloud. The dedicated DICOM store holds raw, intermediate and processed results, as well as providing DICOM interoperability with scanners, PACS, treatment planning, and surgical navigation systems through powerful configurable sender/receiver and forwarding functions.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | Radiology | 892.2020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57812 | 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B358PCI01PF0 | HIBCC |
Customer Contacts
- Phone
- 262-754-3840
- [email protected]