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Basic, Models Basic 1, Basic 2, and Basic 3

by Atys Medical France 510(k)

510(k) K012369

Product code IYN

Overview

The device is a BASIC system, comprising models BASIC 1, BASIC 2, and BASIC 3, as identified in the device name and specifications. It is a medical device manufactured by Atys Medical.

The device received FDA 510(k) clearance under K012369 on August 10, 2001, and was found substantially equivalent to a predicate device. It was reviewed by the Radiology advisory committee and is authorized for marketing in the United States.

Summary written by AI from registry data, 23 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK012369 Date10 Aug 2001ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
IYN
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Atys Medical

Questions

  • What is the BASIC system and what models does it include?

    The BASIC system is a medical device manufactured by Atys Medical that includes three specific models: BASIC 1, BASIC 2, and BASIC 3, as defined in its device name and specifications.

  • When was the BASIC system cleared by the FDA and under which submission?

    The BASIC system received FDA 510(k) clearance under submission number K012369 on August 10, 2001, after being found substantially equivalent to a predicate device.

  • Which advisory committee reviewed the BASIC system during its FDA submission process?

    The BASIC system was reviewed by the Radiology advisory committee, as indicated in the device data under the review_advisory_committee field.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K012369 24 fields · synced 22 Oct 2026