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Lungs and chest · Diagnosis and imaging

AI that double-checks chest X-rays

How it was checked
AI-assisted source check. Not clinically reviewed. ()
Last updated
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Page ID
TR-003

Our editorial standards · 8 references · Corrections

General information only, not medical advice. Talk to your doctor about your situation. Read the disclaimer.

Annalise CXR is AI software that flags possible findings on chest X-rays for radiologists to check. A version of it has FDA 510(k) clearance in the US for triage of some findings, and a large Australian radiology network reported using it in 2021. A radiologist still reads and reports every scan.

How far away is this?

It's cleared by regulators and used with patients. Evidence that it improves patient outcomes (not just reports) is less settled, which is why claim c3 is marked as observational research.

Where is it approved?

RegionRegulatorStatusNotes
United StatesFDAClearedFDA 510(k) clearances for some findings, e.g. K222179 (Annalise Enterprise CXR Triage Trauma, 28 March 2023).[3]
European UnionCE mark / EMACE markedAnnalise Enterprise CXR CE marked under the EU MDR as a Class IIb device (manufacturer announcement).[6]
United KingdomMHRAIn use (MHRA record not verified)The Royal College of Radiologists’ AI registry lists clinical deployments in NHS trusts since 2022. We haven’t checked the MHRA register entry.[7]
AustraliaTGAIn use (regulator record not verified)I-MED Radiology reported using it across its Australian clinics in 2021. The ARTG lists ‘X-ray image interpretive software’ (ARTG 513346, Class IIb, 26 September 2025) from Harrison-AI Medical, Annalise’s maker, but the public entry doesn’t name the product, so it is not confirmed to cover Annalise Enterprise CXR.[8]

Cleared in the US for some findings and CE marked in the EU. Used in NHS hospitals and Australian clinics; we haven’t matched the MHRA or TGA records to this exact product. "Unknown" means we haven't verified it, not that it's unavailable. Approval in one country isn't approval in another.

What is it?

After a chest X-ray, the AI looks for many possible findings and highlights them. The radiologist decides what's real and writes the report. Think of it as a second set of eyes, not a replacement.

What's the evidence?

  1. As of 2021, I-MED Radiology said it had implemented Annalise CXR across its 250 clinics, used by 350 radiologists daily (company statement, July 2021).[1]

    Evidence stage: Approved & in use · #c1

  2. The FDA cleared Annalise Enterprise CXR Triage Trauma through a 510(k) (K222179, 28 March 2023) for triage notification of certain findings.[3]

    Evidence stage: Approved & in use · #c2

  3. A real-world observational study in Australian clinics and hospitals, published in BMJ Open (2021), assessed its effect on radiologist reports.[5]

    Evidence stage: Early research · #c3

What does it mean for me?

If you have a chest X-ray at a clinic that uses it, the AI may help the radiologist spot things. Your report still comes from a person. It's fine to ask whether AI was used.

What could I ask my doctor?

  • Was any AI used in reading my X-ray?
  • Who is responsible for the final report?
  • If something was flagged, what are the next steps?

These are general starting points, not a recommendation to choose any particular test or treatment.

Change history

  • : First published.
  • : Regulator status checked against official records; see Where is it approved?
  • : Updated after independent fact-check and clinical review
  • : Australia row clarified: ARTG 513346 is not confirmed to cover Annalise Enterprise CXR.
  • : Review label corrected: this page was not clinically reviewed. Earlier labels saying 'independent fact-check' and 'clinical review' were wrong; checks so far were AI-assisted source checks only.

General information only, not medical advice. Talk to your doctor about your situation. AI-assisted source check. Not clinically reviewed.

References

  1. I-MED Radiology: Annalise CXR implementation (2021). i-med.com.au (2021). Company document (claim). https://i-med.com.au/articles/annalise-cxr
  2. FDA 510(k) database: K222179 (Annalise Enterprise CXR Triage Trauma). accessdata.fda.gov. Regulator. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222179
  3. FDA 510(k) letter K222179 (PDF). accessdata.fda.gov. Regulator. https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222179.pdf
  4. harrison.ai: FDA 510(k) clearance announcement. harrison.ai. Company document (claim). https://harrison.ai/news/annalise-enterprise-cxr-receives-first-u-s-fda-510k-clearance/
  5. Real-world observational study (PMC8689166). pmc.ncbi.nlm.nih.gov. Peer-reviewed observational study. https://pmc.ncbi.nlm.nih.gov/articles/PMC8689166/
  6. CE mark / EMA record or statement: European Union. harrison.ai. Regulatory or manufacturer record. https://harrison.ai/news/annalise-enterprise-cxr-granted-ce-mark-under-mdr-class-iib-for-clinical-use-in-eu/
  7. MHRA record or statement: United Kingdom. rcr.ac.uk. Regulatory or manufacturer record. https://www.rcr.ac.uk/our-services/artificial-intelligence-ai/ai-registry/annalise-enterprise-cxr/
  8. TGA record or statement: Australia. tga.gov.au. Regulatory or manufacturer record. https://www.tga.gov.au/resources/artg/513346

Publisher shown as the website hosting each source. Dates are given where the source label includes them.