Giotto Image

FDA UDI

Class II (US FDA UDI)

by I.m.s. Internazionale Medico Scientifica Srl

Identity

Trade Name: GIOTTO IMAGE FDA UDI
Generic Name: Stationary mammographic x-ray system, digital FDA UDI
Device Name: Giotto Image is a conventional film-screen x-ray mammographic device. FDA UDI
Model / Reference: GIOTTO IMAGE SRA FDA UDI
Description: Giotto Image is a conventional film-screen x-ray mammographic device. FDA UDI

Identifiers

Catalog Number: 6702 FDA UDI
Primary DI / UDI-DI: 08033837190110 FDA UDI
510(k) Number: K012953 FDA UDI
FDA Product Code: IZH FDA UDI
GMDN Term: Stationary mammographic x-ray system, digital FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1710 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Height — 2240 Millimeter FDA UDI
Depth — 1140 Millimeter FDA UDI
Width — 1150 Millimeter FDA UDI

Category: Stationary mammographic x-ray system, digital

Giotto Image by I.m.s. Internazionale Medico Scientifica Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Stationary mammographic x-ray system, digital.

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Selenia Dimensions — Hologic, Inc. · Class II
Selenia Dimensions — Hologic, Inc. · Class II

Cleared under the same submission

K012953 also covers:

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 d5e96c22-ff29-4e51-b3f4-903a0f314f6f 37 fields · synced May 30, 2026