Identity
- Trade Name
- GIOTTO IMAGE 3DL FDA UDI
- Generic Name
- Mammographic x-ray system stereotactic unit FDA UDI
- Device Name
- GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereotactic biopsy. FDA UDI
- Model / Reference
- GIOTTO IMAGE_21'' 2Mpixel FDA UDI
- Description
- GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereotactic biopsy. FDA UDI
Identifiers
- Catalog Number
- 6902 FDA UDI
- Primary DI / UDI-DI
- 08033837190059 FDA UDI
- 510(k) Number
- K111434 FDA UDI
- FDA Product Code
- MUE FDA UDI
- GMDN Term
- Mammographic x-ray system stereotactic unit 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 — 2240 Millimeter FDA UDIDepth — 1140 Millimeter FDA UDIWidth — 1150 Millimeter FDA UDI
Category: Mammographic x-ray system stereotactic unit
Giotto Image 3dl by I.m.s. Internazionale Medico Scientifica Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mammographic x-ray system stereotactic unit.
- Sample Imaging — GE MEDICAL SYSTEMS, INC. · Class II
- Breast Spacer — GE MEDICAL SYSTEMS, INC. · Class II
- GIOTTO IMAGE 3DL — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL · Class II
- GIOTTO IMAGE 3DL — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL · Class II
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 |
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Manufacturer
- Manufacturer
- I.m.s. Internazionale Medico Scientifica Srl
Sources (1)
- FDA UDI 18d4be82-20a3-4eea-88f3-6233dde056cf 37 fields · synced Jun 1, 2026