FDA UDI
In Commercial Distribution
🇺🇸 United States
Imagio®
DI: 00864802000459
·
Model: 9100
·
Seno Medical Instruments, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Imagio®
- Primary DI
- 00864802000459
- Version / Model
- 9100
- Catalog Number
- 9100-000-02
- Company Name
- Seno Medical Instruments, Inc.
- Labeler DUNS
- 615062499
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-07
- Public Version
- 1
- Public Version Date
- 2023-07-17
- Public Version Status
- New
- Public Device Record Key
- c086f00d-73f7-43e7-a3a2-ae10afbecc17
Device Description
Imagio Breast Imaging System Model 9100
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 |
|---|---|---|---|---|
| QNK | Optoacoustic Imaging System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61018 | Optoacoustic/ultrasound imaging system | A mobile assembly of electrically-powered devices intended for imaging and analysis of soft-tissue and soft-tissue vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging. It includes a processing unit with a monitor, controls, and integrated software, and a dedicated laser-emitting extracorporeal ultrasound transducer. Pulsed near-infrared laser light of various wavelengths is emitted and the associated acoustic feedback (photoacoustic effect) provides complementary information regarding tissue composition/functionality based on the presence of endogenous chromophores, such as haemoglobin; this photoacoustic data can be overlaid on the associated US image. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00864802000459 | GS1 |
Customer Contacts
- Phone
- 888-978-8835
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P200003 | 001 |