Identity
- Trade Name
- GIOTTO IMAGE 3DL FDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- It's an amorphous selenium detector 24 x 30 cm that directly captures x-rays and converts the them into electronic signal from which the images are constructed. FDA UDI
- Model / Reference
- Amorphous Selenium detector FDA UDI
- Description
- It's an amorphous selenium detector 24 x 30 cm that directly captures x-rays and converts the them into electronic signal from which the images are constructed. FDA UDI
Identifiers
- Catalog Number
- D75 FDA UDI
- Primary DI / UDI-DI
- 08033837190028 FDA UDI
- 510(k) Number
- K111434 FDA UDI
- FDA Product Code
- MUE FDA UDI
- GMDN Term
- Stationary mammographic x-ray system, digital 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 — 35 Millimeter FDA UDIDepth — 348 Millimeter FDA UDIWidth — 347 Millimeter FDA UDI
Category: Stationary mammographic x-ray system, digital
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 Stationary mammographic x-ray system, digital.
- Magnification table — FUJIFILM Corporation · Class II
- Compression plate for axilla radiography — FUJIFILM Corporation · Class II
- Selenia Dimensions — Hologic, Inc. · Class II
- Selenia® Dimensions® — Hologic, Inc. · Class II
- Senographe Pristina — GE MEDICAL SYSTEMS, INC. · Class II
- 3Dimensions — Hologic, Inc. · Class III
- Selenia Dimensions — Hologic, Inc. · Class II
- Selenia Dimensions — Hologic, Inc. · 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 0e3c04d2-35e4-457d-ab61-7155e0df6775 37 fields · synced May 29, 2026