Identity
- Trade Name
- GIOTTO IMAGE 3DL FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- MAW is a Management & Acquisition Workstation with 21" LCD 2Mpixel monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner. FDA UDI
- Model / Reference
- MAW FDA UDI
- Description
- MAW is a Management & Acquisition Workstation with 21" LCD 2Mpixel monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner. FDA UDI
Identifiers
- Catalog Number
- 6006-15GM3 FDA UDI
- Primary DI / UDI-DI
- 08033837190035 FDA UDI
- 510(k) Number
- K111434 FDA UDI
- FDA Product Code
- MUE FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1715 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 1920 Millimeter FDA UDIDepth — 470 Millimeter FDA UDIWidth — 1175 Millimeter FDA UDI
Category: Radiology DICOM image processing application software
Giotto Image 3dl by I.m.s. Internazionale Medico Scientifica Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K111434 also covers:
- GIOTTO IMAGE 3DL — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
- GIOTTO IMAGE 3DL — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
- GIOTTO IMAGE 3DL — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
- GIOTTO IMAGE 3DL — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
- GIOTTO IMAGE — IMS GIOTTO SPA
- GIOTTO IMAGE — IMS GIOTTO SPA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- I.m.s. Internazionale Medico Scientifica Srl
Sources (1)
- FDA UDI 9426ebb4-ffe9-4f58-b7fe-4d6507156155 37 fields · synced Jun 6, 2026