FDA UDI
In Commercial Distribution
🇺🇸 United States
PROMAP – 3D PROSTATE SUITE
DI: 03665134000714
·
Model: KSOF-2602
·
KOELIS
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PROMAP – 3D PROSTATE SUITE
- Primary DI
- 03665134000714
- Version / Model
- KSOF-2602
- Company Name
- KOELIS
- Labeler DUNS
- 290318455
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-21
- Public Version
- 1
- Public Version Date
- 2022-07-29
- Public Version Status
- New
- Public Device Record Key
- 1e2c0ba0-bafa-4a3e-9083-aba96578ca63
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
- No
- 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 |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | 892.1550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47502 | Image segmentation application software | An application software program intended to convert large volumes of slice-based images into manageable three-dimensional (3-D) models of anatomical structures. It is typically used in an electrophysiology (EP) procedure (e.g., a cardiac mapping) to accept DICOM3 images from computed tomography (CT) and magnetic resonance imaging (MRI) scanners. Once the images are imported, a 3-D model can be extracted in a process called segmentation (the isolation of an object of interest) for easy viewing and manipulation during the EP procedure. This device is typically identified by a proprietary name and "version" or "upgrade" number. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03665134000714 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170521 | 000 |