FDA UDI
In Commercial Distribution
🇺🇸 United States
SureWave Elastography
DI: 00814848020775
·
Model: Q7000225
·
QUALITY ELECTRODYNAMICS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SureWave Elastography
- Primary DI
- 00814848020775
- Version / Model
- Q7000225
- Company Name
- QUALITY ELECTRODYNAMICS LLC
- Labeler DUNS
- 614760119
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-12
- Public Version
- 1
- Public Version Date
- 2025-04-21
- Public Version Status
- New
- Public Device Record Key
- 265fb940-f529-473c-8595-882535c668ae
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65288 | Magnetic resonance elastography acoustic driver | An assembly of devices, consisting of an electrically-powered pneumatic wave generator and a noninvasive vibration applicator, intended for use with a magnetic resonance imaging (MRI) system to provide a measure of tissue elasticity/stiffness. The generator is used outside the MRI scanner room and is connected by pneumatic tubing to the applicator, which is applied to the site of interest on the patient’s body while within the MRI scanner. The pneumatically-transferred vibrations are applied to the body and MRI images are taken to facilitate evaluation/diagnosis of the condition of tissues (e.g. liver, brain), including damage and tumours. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814848020775 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242006 | 000 |