FDA UDI
In Commercial Distribution
🇺🇸 United States
GIOTTO IMAGE 3DL
DI: 08033837190035
·
Model: MAW
·
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- GIOTTO IMAGE 3DL
- Primary DI
- 08033837190035
- Version / Model
- MAW
- Catalog Number
- 6006-15GM3
- Company Name
- I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
- Labeler DUNS
- 429113525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 6
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- 9426ebb4-ffe9-4f58-b7fe-4d6507156155
Device Description
MAW is a Management & Acquisition Workstation with 21" LCD 2Mpixel monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner.
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 |
|---|---|---|---|---|
| MUE | Full Field Digital,System,X-Ray,Mammographic | Radiology | 892.1715 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57812 | Radiology DICOM image processing application software | A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033837190035 | GS1 | ||||
| Package | 18033837190032 | GS1 | X003411 | 1 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111434 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 1920 | Millimeter | |
| Depth | 470 | Millimeter | |
| Width | 1175 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius