Arco FP-S
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- ARCO FP-S EUDAMED
- Device Name
- ARCO FP-S EUDAMED
- Model / Reference
- ARCO FP-S EUDAMED95 01 000; 95 03 000; 95 06 000; 95 08 000 EUDAMEDARCO FP-SR21 EUDAMED95 01 000 / 95 03 000 / 95 06 000 / 95 08 000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055186670501 EUDAMED
- Basic UDI-DI
- 805518667FP-SFH EUDAMEDB-08055186670501 EUDAMED
- Direct Marketing DI
- 08055186670501 EUDAMED
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Arco FP-S is a mobile fluoroscopy system (Nomenclature Code: Z11039017) designed for real-time radiographic imaging. It features a flat-panel detector for high-resolution visualization, enabling intraoperative guidance during surgical, diagnostic, and interventional procedures. Classified as a Class IIb device, it is intended for use in radiology settings where dynamic imaging is required.
Supplied as a non-sterile, non-reusable device, the Arco FP-S is intended for use in clinical environments where mobility and high-resolution imaging are critical. It is regulated under FDA 510K clearance, MDD, and MDR compliance, with a Basic UDI of 805518667FP-SFH. The system is designed for intraoperative applications and adheres to radiology-specific standards, ensuring compatibility with surgical workflows while maintaining safety and performance standards.
Frequently asked questions
Is the Arco FP-S system designed for single-use or can it be reused in a clinical setting?
The Arco FP-S is explicitly supplied as a non-reusable device, as indicated by the `REUSABLE: 0` field. This means it is intended for use in a single procedure or session before disposal, aligning with its classification as a mobile fluoroscopy system for intraoperative guidance.
What regulatory pathways does the Arco FP-S follow for market authorization?
The Arco FP-S is authorized through FDA 510K clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) compliance. It was determined to be substantially equivalent (decision_code: SESE) by the FDA’s Radiology (RA) advisory committee, with a Basic UDI (805518667FP-SFH) for traceability. These pathways reflect its classification as a Class IIb device.
How is the Arco FP-S sterilized, and is it provided in a sterile condition?
The Arco FP-S is non-sterile (`STERILE: 0`) and not sterilized (`STERILIZATION: 0`) for clinical use. It is supplied as-is for intraoperative settings where sterility is not required, such as radiology or surgical environments needing mobility and high-resolution imaging.
What are the key features that distinguish the Arco FP-S from other fluoroscopy systems?
The Arco FP-S is a mobile fluoroscopy system with a flat-panel detector for high-resolution, real-time radiographic imaging. Its mobility and intraoperative design cater to surgical, diagnostic, and interventional procedures, while its non-reusable nature (`REUSABLE: 0`) and non-sterile status (`STERILE: 0`) align it with workflows where portability and single-use convenience are prioritized.
What UDI (Unique Device Identifier) should be referenced when ordering or tracking the Arco FP-S?
The Basic UDI for the Arco FP-S is 805518667FP-SFH, with associated UDI data identifiers like the ULID (01KQSK8WS8R7J0QYRDZ10MAM2A) and UUID (bff865d7-9c5a-4758-b9d5-ade21cca3a93). These codes ensure traceability and compliance with regulatory requirements for device tracking and recall management.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Arco FP-S - ATS, ARCO FP-S by A.T.S. Applicazione Tecnologie Speciali S.R.L. | FDA 510 ..., Arco FP-S - ATS - Applicazione Tecnologie Speciali - PDF Catalogs ..., ARCO FP - ATS - Applicazione Tecnologie Speciali - PDF Catalogs ...
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 805518667FP-SFH | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K211777 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K182086 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 805518667FP-SFH | Class IIb | Active |
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Manufacturer
- Manufacturer
- A.T.S. Applicazione Tecnologie Speciali s.r.l.
- EUDAMED SRN
- IT-MF-000010734
Sources (4)
- EUDAMED f3c232fd-f174-4fc3-9bc7-b7a4b49a7cc5 85 fields · synced Oct 6, 2026
- EUDAMED 67b76c8d-e6fe-453e-80fe-801bc9324b9f 61 fields · synced May 18, 2026
- EUDAMED f3c232fd-f174-4fc3-9bc7-b7a4b49a7cc5-1 61 fields · synced Jun 10, 2026
- FDA 510(k) K211777 1 fields · synced May 18, 2026