Skip to content

Exa

by Konica Minolta Healthcare Americas, Inc 510(k)

Active United States

510(k) K203743

Overview

Exa is a diagnostic imaging platform that integrates with AWS HealthImaging to provide access to various solutions including data anonymization, AI, business intelligence and Pharma. The platform decouples customer data from Exa PACS, allowing for enhanced clinical workflow management.

Exa is supplied as part of the Exa Enterprise solution and is managed by Konica Min Healthcare Americas, Inc. The device has received FDA 510K clearance with the product code LLZ and is intended for use in radiology settings. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK203743 Date10 Dec 2021ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
FDA applicant
Konica Minolta Healthcare Americas, Inc.
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Konica Minolta Healthcare Americas, Inc

Questions

  • What is the EXA diagnostic imaging platform?

    EXA is a diagnostic imaging platform that integrates with AWS HealthImaging to provide access to various solutions including data anonymization, AI, business intelligence and Pharma. It decouples customer data from Exa PACS for enhanced clinical workflow management.

  • How is the EXA platform supplied and managed?

    EXA is supplied as part of the Exa Enterprise solution and is managed by Konica Minolta Healthcare Americas, Inc. The device is intended for use in radiology settings and has received FDA 510K clearance with product code LLZ.

  • Is the EXA device single-use or reusable?

    The device is not specified as single-use or reusable in the provided information. No details regarding sterility, MRI safety, or storage conditions are available in the device data.

  • What regulatory approvals does the EXA platform have?

    The EXA platform has received FDA 510K clearance with the product code LLZ. It was filed under the Radiology advisory committee and received a decision code of SESE (Substantially Equivalent Special).