meddevicedb.com FDA Device Reference

ARCO FP

K182086 Class II Traditional
Decision Date
2019-08-20
Sponsor / Applicant
A.T.S. Applicazione Tecnologie Speciali S.R.L.

Technical Specification

510(k) Submission ID K182086
Product Code OWB
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1650
Decision Date 2019-08-20
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

ARCO FP received FDA 510(k) clearance under submission number K182086, sponsored by A.T.S. Applicazione Tecnologie Speciali S.R.L.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-08-20.

Classification & Regulation

This clearance is catalogued under FDA product code OWB and 21 CFR 892.1650, within the Radiology review panel as a Class II device.