FDA UDI
In Commercial Distribution
🇺🇸 United States
ENDOPRO IQ
DI: 04961333243891
·
Model: M70228
·
PENTAX OF AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ENDOPRO IQ
- Primary DI
- 04961333243891
- Version / Model
- M70228
- Company Name
- PENTAX OF AMERICA, INC.
- Labeler DUNS
- 083211284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-14
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- 5d153acc-17ae-4785-adf5-def663e232dd
Device Description
HITACHI SONOELASTOG SOFTWR/HV PREIRUS-B
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
- 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 |
|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35953 | Diagnostic imaging telemedicine system | An assembly of devices designed to electronically transmit digitized radiology images, e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine, ultrasound, endosocopy or CT, and consultative text to one or more remote sites (teleradiology). The information is typically transmitted through, e.g., public service transmission channels, phone lines or microwave relays. It is primarily distinguished from a picture archiving and communication system (PACS) by its storage capacity and intended use. PACS is a large storage system and file controller storing and retrieving thousands of images, whilst a teleradiology system typically has a storage capacity of fewer than 1, 000 images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04961333243891 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093466 | 000 |