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Siremobil Iso-C 3D

by Siemens AG

510(k) K032280

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 · Abbreviated NumberK032280 Date10 Sep 2003ClearedStatusActive

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  • Withdrawn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
IZL
Device Class
Class II
Regulation
21 CFR Part 892.1720
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 SIREMOBIL ISO-C 3D is a mobile X-ray system designed for radiological imaging. It is a substantially equivalent device cleared under FDA 510(k) process with product code IZL and regulation number 892.1720, classified as a Class II medical device.

Manufactured by Siemens AG, the device is supplied as a non-sterile, reusable system intended for use in clinical radiology settings. It requires standard storage and handling conditions as per manufacturer guidelines, and its regulatory status is based on FDA clearance K032280 granted on September 10, 2003.

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