AI Radiology Triage Software for a Mid-Size US Hospital: Pilot Aidoc and RapidAI, Not Yet Adopt
Verdict
Interpretation: The category is AI radiology triage (computer-aided triage and notification) for a mid-size US hospital under FDA and HIPAA. I scored Aidoc in full because it has the most recent, verifiable FDA activity and a documented Epic listing. Viz.ai and RapidAI are scored in summary. The must-haves are Epic EHR integration, SOC 2 Type II and an on-prem option. All three were stated by the requester, so none is inferred. Today is 6 October 2026.
Verdict: pilot, with conditions. Aidoc is the strongest fit on FDA clearance and Epic integration. No vendor I reviewed publicly proves all three must-haves. Aidoc and Viz.ai appear to run AI inference in the cloud, so on-prem fails or is unproven for them. RapidAI claims an on-prem option, but I found no Epic listing for it. Confirm these gaps in writing before signing anything. This is a recommendation for your team to confirm, not a purchasing decision, and it says nothing about whether your hospital is compliant.
Scorecard (Aidoc, primary candidate)
| Dimension | Finding | Evidence type | Source link | Rating |
|---|---|---|---|---|
| Regulatory / compliance | FDA 510(k) K252970, BriefCase-Triage: CARE Multi-triage CT Body, received 17 Sep 2025, decision 7 Jan 2026. A second entry, K253578 (pneumothorax, pericardial effusion, large aortic aneurysm, shoulder fracture or dislocation), shows decision 26 Feb 2026, Substantially Equivalent, product code QAS. | Independent (FDA registry) | FDA 510(k) database | Strong |
| Validation evidence | Vendor reports that in the FDA-reviewed pivotal study the 11 new indications had mean sensitivity of 97% and mean specificity of 98%. I did not retrieve the FDA summary PDF or an independent peer-reviewed study of the CARE model. | Vendor | Aidoc press release (date not shown on fetched page) | Weak |
| Performance | The same release claims roughly an order-of-magnitude reduction in false alerts against single-condition tools. This is a marketing claim with no independent benchmark found. | Vendor | Aidoc press release | Unknown |
| Security & privacy | The trust center portal lists HIPAA, ISO/IEC 27001, SOC 2, TX-RAMP and ISO 13485 but the reports are gated. A third-party aggregator notes the SOC 2 type (1 or 2) is not stated on any public page. The portal also logs a 4 Feb 2026 incident involving a third-party website widget: containment the same day and a forensic review of HubSpot and Salesforce integrations. The vendor states no PHI, patient data or customer data was affected and classifies it as a false positive (vendor claim). | Vendor (plus third-party aggregator) | Aidoc trust center | Adequate |
| Integration | Live in the Epic App Orchard (announcement undated on the page; circa 2022), and the platform connects over DICOM, HL7 and FHIR. The Epic evidence is more than two years old. | Vendor | Aidoc press release; integrations page | Adequate |
| Pricing & contract | No public pricing found. I did not retrieve Aidoc's terms of service. | None | n/a | Unknown |
| Vendor viability | $150 million round (July 2025 per my notes; date not on the fetched page), total funding $370 million, led by General Catalyst and Square Peg, with four US health systems participating. Vendor claims 150+ health systems and 1,600+ hospitals. | Vendor | Aidoc funding release | Strong |
| Risks | Cloud inference, gated SOC 2 detail, undated VA security document, early-2026 website incident, unpriced contract. See the risk list below. | Mixed | n/a | Adequate |
Must-have checklist
| Requirement | Status | Evidence and source |
|---|---|---|
| Integrates with Epic EHR | Pass for Aidoc (dated); unclear for Viz.ai and RapidAI | Aidoc: Epic App Orchard go-live announcement, undated, circa 2022. Viz.ai: a third-party review says Epic integration is institution-specific and not a standard feature, with no native write-back; this is unaudited. RapidAI: I found only a claim of vendor-agnostic integration, no Epic listing. |
| SOC 2 Type II | Vendor-claimed pass for Viz.ai (Type II stated only in a 2024 release); unclear for Aidoc; vendor-claimed for RapidAI | Viz.ai: trust center lists SOC 2 and HIPAA, with the Type II label not shown there, and a Feb 2024 release reports a Big Four audit. I have not seen the report itself. Aidoc: SOC 2 listed, type not public (see above). RapidAI: lists "SOC2 Type 2" among its certifications, a vendor claim. |
| On-prem deployment option | Fail (as documented) for Aidoc and Viz.ai; claimed for RapidAI | Aidoc: a VA-hosted security overview (undated, version 1.1) says studies are de-identified and uploaded to the cloud analysis server. Only the orchestration step runs on-premises. Viz.ai: no on-prem option found; a third-party review describes routing studies to the Viz.ai cloud. RapidAI: Hybrid, On-Prem and Cloud models, vendor claim. |
Vendor comparison
| Vendor | FDA position | Security attestation | Deployment | Viability signal | Source |
|---|---|---|---|---|---|
| Aidoc | Two 2026 CARE triage 510(k) decisions (above) | SOC 2 listed, type gated | Cloud analysis, on-prem orchestrator | $370M total funding | Aidoc funding release |
| Viz.ai | Vendor says 13 FDA clearances (July 2026); clearance numbers not checked by me | SOC 2 Type II, ISO 42001 stated | Cloud (third-party review; vendor subprocessor list is gated) | Headcount 374 in March 2026, down from 528 in 2023 (Revelio estimate); last disclosed $100M Series D at $1.2B valuation in 2022 | Viz.ai trust center |
| RapidAI | Not checked by me | SOC 2 Type 2 claimed, trust center gated | Hybrid, on-prem, cloud (vendor) | Vendor claims 2,500+ hospitals | RapidAI infrastructure page |
The Viz.ai headcount decline is a third-party estimate and does not by itself show financial distress. A third-party site also claims Viz.ai has "50+ FDA clearances", which conflicts with the vendor's own count of 13, so treat that site's figures with caution. It also quotes a price range of USD 150,000 to 300,000 per site per year for stroke deployments, which the site itself says is not independently audited. I treat it as an unverified estimate for budgeting only.
Top risks and questions for the vendor
- Cloud inference conflicts with an on-prem requirement. Ask Aidoc and Viz.ai: "Do you offer a fully on-premises inference option, and what is the roadmap?" Ask RapidAI for the Rapid Edge Cloud architecture document and the list of algorithms available on-prem.
- Unverified SOC 2 Type II. Request the current SOC 2 Type II report (period dates, auditor, exceptions) through each trust center under NDA.
- Stale Epic evidence. Ask each vendor for its live Epic Showroom entry and a reference site on your Epic version. Aidoc's announcement is from 2022. Clarify whether results write back to Epic.
- Early-2026 Aidoc website incident. Ask for the closure report: the vendor says no PHI was affected; ask for the written closure report and what changed.
- Pricing, renewal and data exit are unknown. Request a written quote, auto-renewal terms, liability caps and data-return terms. Also ask for the BAA (HIPAA business associate agreement) and subprocessor list.
Alternatives worth comparing
- Viz.ai: strongest published SOC 2 Type II position but cloud only and Epic depth unclear.
- RapidAI: the only one of the three that claims on-prem deployment; verify its radiology (non-stroke) triage clearances and Epic fit.
- Annalise.ai (Annalise Enterprise, K250831): appeared in an FDA 510(k) listing but I did not assess it; shortlist only if chest X-ray triage is a priority.
Do next
- Send each shortlisted vendor the five questions above, in writing, and ask for the SOC 2 Type II report, BAA and subprocessor list.
- Pull the FDA summary PDFs for K252970 and K253578, and confirm which clearances cover the exam types your hospital reads.
- Ask your Epic team to check each vendor's Showroom listing and your Epic version.
- Define the on-prem requirement: is it data residency, or only outage resilience? RapidAI's "on-prem fallback" and Aidoc's on-prem orchestration may satisfy the second.
- Run a time-limited pilot on one modality with your own retrospective cases to measure sensitivity, specificity and alert burden.
Open items
- Not verified: FDA clearance numbers for Viz.ai and RapidAI; independent peer-reviewed validation of Aidoc CARE; recall, MAUDE, warning-letter and breach-portal checks for all three vendors.
- Near-miss evidence: the aggregator aifoxx.com (last verified 29 June 2026) says Aidoc's SOC 2 type could not be confirmed. The VA security overview is undated, so its architecture may have changed.
- Pricing: no vendor price was verified from a primary source.
Coverage
Not reached: gated trust-center documents (Aidoc SafeBase, RapidAI, Viz.ai SOC 2 report), the Epic Showroom listing pages, vendor terms of service, G2 and Capterra reviews, and FDA recall and MAUDE databases.
Sources
- FDA 510(k) K252970, BriefCase-Triage: CARE Multi-triage CT Body (retrieved 6 Oct 2026)
- FDA 510(k) K253578, Aidoc CARE Multi-Triage CT (page updated 5 Oct 2026)
- Aidoc FDA clearance press release (date not shown on page)
- Aidoc trust center (SafeBase portal, retrieved 6 Oct 2026)
- Aidoc Epic App Orchard announcement (undated, circa 2022)
- Aidoc systems integrations page
- Aidoc aiOS platform page
- Aidoc blog on on-premises orchestration (6 May 2025)
- VA-hosted Aidoc Solution Security Overview V1.1 (undated)
- Aidoc $150M funding release (July 2025, date unconfirmed)
- AIFOXX Aidoc certification ledger (verified 29 Jun 2026)
- Viz.ai Trust Center (retrieved 6 Oct 2026)
- Viz.ai SOC 2 Type II announcement (26 Feb 2024)
- Viz.ai 10-year anniversary release (28 Jul 2026)
- Viz.ai Series D release (7 Apr 2022)
- Revelio Labs Viz.ai headcount (March 2026 data)
- MedAI Verdict Viz.ai review (verified 4 Sep 2026, third-party)
- RapidAI IT and deployment page
- RapidAI enterprise infrastructure page
- RapidAI hemorrhagic stroke page (hospital count claim)
- Innolitics listing for Annalise Enterprise K250831