IMS GIOTTO S.p.A.

FDA Device Registration & Listing · Sasso Marconi Bologna, IT · Registration 9680027

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9680027
FEI Number
3002807317
Entity Name
IMS GIOTTO S.p.A.
City/State/Country
Sasso Marconi Bologna, IT
Establishment Address
Via Sagittario, 5, Sasso Marconi Bologna 40037, IT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
IMS GIOTTO S.p.A. (Owner Number: 10028474)
Owner / Operator Contact Address
Via Sagittario, 5, Sasso Marconi, IT-BO 40037, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K925212
PMA Number
N/A

All Registered Proprietary Names

GIOTTO IMAGE 3D-3DL GIOTTO IMAGE GIOTTO CLASS BIOPSY DIGIT BIOPSY DIGIT S/SL Smart Finder MAMMOBED

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2011-11-25
IZH System, X-Ray, Mammographic Radiology Class 2 892.1710 2009-02-04
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2021-03-19
IZH System, X-Ray, Mammographic Radiology Class 2 892.1710 2009-02-04
IZH System, X-Ray, Mammographic Radiology Class 2 892.1710 2012-12-18
IZH System, X-Ray, Mammographic Radiology Class 2 892.1710 2023-04-06
IZH System, X-Ray, Mammographic Radiology Class 2 892.1710 2009-02-04

Official Correspondent

Antonella Rossi

US Agent Details

Silvia Tamarri Business: THEMA CORP Email: usreg@complifegroup.com Phone: (215) 8459459

Related Public Records

Same Entity

IMS GIOTTO S.p.A.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3023003446 BLOCK IMAGING SAS Weyersheim Bas-Rhin, FR
3005172103 DRTECH Corporation Seongnam-si Gyeonggi, KR
3010703925 MAKAR CONSULTING PTY LTD Belrose New South Wales, AU
3015276088 CAN TECHNOMED TRADING LTD. Richmond British Columbia, CA
3031503890 BLOCK IMAGING PARTS & SERVICE Holt, MI, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680027. Last updated year: 2026. Please use registration number 9680027 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.