Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011347852

FEI Number

3011347852

Entity Name

A.T.S. Applicazione Tecnologie Speciali s.r.l.

City/State/Country

Torre de Roveri Bergamo, IT

Establishment Address

Via Alessandro Volta, 10, Torre de Roveri Bergamo 24060, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SEDECAL S.A. (Owner Number: 9039772)

Owner / Operator Contact Address

PELAYA, 9 POL., POL. IND. "RIO DE JANEIRO", ALGETE, ES-M 28110, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211777

PMA Number

N/A

All Registered Proprietary Names

Persona C HR OMNISCOP DReam ARCO FP Omniscop FP Persona C AMRAD Medical Agility Plus Cyberbloc FP PRIMO S ARCO FP-S OMNISCOP Dream-S Omniscop FP-S Persona CS AMRAD Medical Agility Cyberbloc FP-S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-06-24
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-06-24
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2019-10-21
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2019-10-21
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-07-10
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2021-08-14
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-08-14

Official Correspondent

No official correspondent registered.

US Agent Details

Devan Moser Business: Sedecal USA Inc. Email: DMOSER@SEDECALUSA.COM Phone: (847) 3946960

Related Public Records

Same Entity

SEDECAL S.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006972752	Stephanix	La Ricamarie Auvergne-Rhone-Alpes, FR
3009868110	Metaltronica Spa	Pomezia Roma, IT
9617251	SEDECAL S.A.	ALGETE Madrid (Province), ES

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K060344	Breakaway Imaging, LLC	O-ARM IMAGING SYSTEM	2006-03-29
K982706	Philips Medical Systems, Inc.	PHILIPS BV300 SERIES RELEASE 2.1	1998-09-02
K163715	Philips Medical Systems Nederland B.V.	Allura Xper R9	2017-01-26
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0002-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0003-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0004-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0005-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Similar Registrations

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3005877899	METROPOLIS INTERNATIONAL, LLC	Long Island City, NY, US
3010703925	MAKAR CONSULTING PTY LTD	Belrose New South Wales, AU
3002466018	Siemens Healthineers AG	KEMNATH Bavaria, DE
3008496839	EvERX PTY LTD	Sydney New South Wales, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011347852. Last updated year: 2026. Please use registration number 3011347852 when referencing this establishment in official correspondence.