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Imbio RV/LV Software

by Imbio, LLC

510(k) K203256

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203256 Date9 Mar 2021ClearedStatusActive

Official records

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  • Withdrawn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
QIH
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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 Imbio RV/LV Software is a diagnostic medical device classified as a Computerized Tomography (CT) Image Processing Software (Product Code: QIH). It is designed to analyze volumetric computed tomography pulmonary angiography (CTPA) scans and automatically measure the maximal diameters of the right and left ventricles of the heart. Using an artificial intelligence algorithm, the software identifies and quantifies these structures to generate the right-to-left ventricular (RV/LV) ratio. This ratio aids in the assessment of pulmonary hypertension and related cardiac conditions.

The software is intended for use in radiology settings where CTPA scans are performed. It operates on existing CTPA image data and integrates results directly into the picture archiving and communication system (PACS). As noted in its documentation, the Imbio RV/LV Software is for investigational use only and requires compatibility with standard medical imaging workflows. No regulatory approval beyond the FDA 510(k) clearance (K203256) is stated in the provided data, and its use is governed by the manufacturer’s guidelines for diagnostic imaging analysis.

Devices cleared under K203256

5 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K203256
UDI-DISize and differences
Imbio RV/LV 2.0
Imbio, LLC
2.000850894007605 —On the market
Imbio RV/LV 2.1
Imbio, LLC
2.100850894007636 —On the market
Imbio RV/LV 3.0.0
Imbio, LLC
3.0.000850894007643 —On the market
Imbio RV/LV 3.1.0
Imbio, LLC
3.1.000850894007728 —On the market
Imbio RV/LV 3.1.1
Imbio, LLC
3.1.100850894007766 —On the market

Similar devices

Other devices filed under FDA product code QIH (Automated Radiological Image Processing Software).

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