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I3 System-Abd Diagnostic Ultrasound

by Innovative Imaging, Inc.

510(k) K041947

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK041947 Date16 Aug 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0148-2008 FDA Unclassified (pre-2012) initiated 25 Sep 2007

    Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations.

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  • Withdrawn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
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 I3 System ABD Diagnostic Ultrasound is a diagnostic ultrasound device classified under the product code IYO, designed for ophthalmic imaging. It generates high-resolution images of the eye’s internal structures, aiding in the assessment of conditions such as retinal detachments, orbital lesions, tumors, foreign bodies, inflammation, and vascular irregularities. This device operates within the radiology domain, adhering to established ultrasound imaging principles for ocular diagnostics.

This device is supplied as a reusable medical instrument, intended for use in clinical radiology settings. It is not sterile upon delivery and requires appropriate cleaning and maintenance between uses. The I3 System ABD Diagnostic Ultrasound holds FDA 510(k) clearance under the Traditional pathway, with a decision date of August 16, 2004. No specific MRI safety classification or single-use designation is indicated in the available data.

Other devices from Innovative Imaging, Inc.

  • I3SYSTEM-Abd

    Class II

Questions

AI-generated answers, 20 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 clinical conditions can the I3 System ABD Diagnostic Ultrasound help diagnose in the eye?

    The I3 System ABD Diagnostic Ultrasound is specifically designed for ophthalmic imaging to assess internal eye structures. It aids in diagnosing conditions such as retinal detachments, orbital lesions, tumors, foreign bodies, inflammation, and vascular irregularities by generating high-resolution ultrasound images.

  • Is the I3 System ABD Diagnostic Ultrasound intended for single-use or reusable in clinical settings?

    The I3 System ABD Diagnostic Ultrasound is supplied as a reusable medical instrument. It requires proper cleaning and maintenance between uses, as it is not sterile upon delivery. This makes it suitable for repeated use in clinical radiology environments.

  • How was the FDA clearance for the I3 System ABD Diagnostic Ultrasound obtained, and what does that mean for its use?

    The I3 System ABD Diagnostic Ultrasound received FDA clearance under the Traditional 510(k) pathway, determined to be substantially equivalent to a legally marketed predicate device. This clearance allows it to be marketed and used in the U.S. for its intended purpose as an ophthalmic diagnostic ultrasound device.

  • What type of maintenance or preparation is required before using the I3 System ABD Diagnostic Ultrasound?

    Since the I3 System ABD Diagnostic Ultrasound is not sterile upon delivery and is reusable, it must undergo appropriate cleaning and maintenance procedures between uses. This ensures proper hygiene and functionality for accurate imaging in clinical radiology settings.