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Cardiop-B System, Version 2.1

by Paieon, Inc.

510(k) K072591

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK072591 Date10 Oct 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IZI
Device Class
Class II
Regulation
21 CFR Part 892.1600
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cardiop-B System, Version 2.1 is a System, X-Ray, Angiographic device classified under product code IZI. It is designed for use in radiology procedures and operates under special controls as a Class II medical device.

The device is manufactured by Paieon, Inc. and received FDA 510(k) clearance on October 10, 2007, with the decision code SESE. It is authorized under regulation number 892.1600 and was reviewed by the Radiology advisory committee.

Other devices from Paieon, Inc.

See all devices from Paieon, Inc. →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Cardiop-B System Version 2.1 used for?

    The Cardiop-B System Version 2.1 is designed for use in radiology procedures as a System, X-Ray, Angiographic device. It operates under special controls as a Class II medical device, specifically for angiographic imaging applications.

  • What is the regulatory status of the Cardiop-B System Version 2.1?

    The Cardiop-B System Version 2.1 received FDA 510(k) clearance on October 10, 2007, with the decision code SESE, indicating it was found to be substantially equivalent to predicate devices. It is authorized under regulation number 892.1600.

  • Who manufactures the Cardiop-B System Version 2.1 and where is it produced?

    The Cardiop-B System Version 2.1 is manufactured by Paieon, Inc., located at 22 Hamelacha St., P.O.B. 11355 in Rosh Haayin, Israel. The company received FDA clearance for this device in 2007.

  • What advisory committee reviewed the Cardiop-B System Version 2.1?

    The Cardiop-B System Version 2.1 was reviewed by the Radiology advisory committee (RA) during the FDA 510(k) clearance process. This committee specializes in evaluating radiology devices for safety and effectiveness.