FDA UDI
In Commercial Distribution
🇺🇸 United States
Acteon Imaging Suite
DI: D8049902630
·
Model: ACTEON IMAGING SUITE (DVD):
·
DE GÖTZEN SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Acteon Imaging Suite
- Primary DI
- D8049902630
- Version / Model
- ACTEON IMAGING SUITE (DVD):
- Catalog Number
- 990263
- Company Name
- DE GÖTZEN SRL
- Labeler DUNS
- 433051802
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-08
- Public Version
- 2
- Public Version Date
- 2023-04-25
- Public Version Status
- Update
- Public Device Record Key
- 53d6d337-2a05-4d35-a18e-ce863416dd28
Device Description
Acteon Imaging Suite software program is an application software for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations. It is distributed on DVD
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 |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40878 | Panoramic/tomographic dental x-ray system application software | An application or operating data program designed for use in, or together with a panoramic/tomographic dental x-ray system configuration. A basic set of applications programs and routines are included with any computer-controlled diagnostic imaging system. Some applications software routines or groups of routines (packages) must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are 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 | D8049902630 | HIBCC |
Customer Contacts
- Phone
- +390331376760
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192165 | 000 |