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IC-PRO System, Version 3.1.0.4

by Paieon, Inc.

510(k) K082907

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 · Traditional NumberK082907 Date18 Nov 2008ClearedStatusActive

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  • Withdrawn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, 27 Sep 2026

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

The IC-PRO System, Version 3.1.0.4 is an angiographic x-ray system. It is classified as a Class II medical device under regulation number 892.1600 and product code IZI.

The device received FDA 510(k) clearance (K082907) on November 18, 2008, and is substantially equivalent to predicate devices. It is manufactured by Paieon, Inc. and used in radiology settings.

Other devices from Paieon, Inc.

See all devices from Paieon, Inc. →

Questions

AI-generated answers, 27 Sep 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 IC-PRO System, Version 3.1.0.4 used for?

    The IC-PRO System, Version 3.1.0.4 is an angiographic x-ray system used in radiology settings to perform vascular imaging procedures, enabling visualization of blood vessels during diagnostic and interventional radiology exams.

  • Who manufactures the IC-PRO System, Version 3.1.0.4 and where are they located?

    The IC-PRO System, Version 3.1.0.4 is manufactured by Paieon, Inc., located at 22 Hamelacha St., P.O.B. 11355, Rosh Haayin, Israel, with postal code 48901.

  • What regulatory clearance does the IC-PRO System, Version 3.1.0.4 have and when was it granted?

    The IC-PRO System, Version 3.1.0.4 received FDA 510(k) clearance under submission number K082907 on November 18, 2008, and is classified as a Class II medical device under regulation 892.1600 with product code IZI.