Release and scope verification
Map installed build, options, population, anatomy, inputs, outputs, and enabled functions to DEN230023.
exact submission · checked 2026-09-04FDA-authorized profile
Rho
16 Bit Inc
Rho analyzes standard frontal radiographs opportunistically to identify patients aged 50 years and older who may have low bone mineral density and to prompt clinical bone-health assessment.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Rho analyzes standard frontal radiographs opportunistically to identify patients aged 50 years and older who may have low bone mineral density and to prompt clinical bone-health assessment.
- Intended users
- Radiologists and referring clinicians or other physician interpreters.
- Care setting and population
- Radiology and imaging-clinic workflows where standard frontal radiographs are already obtained.
- Workflow role
- Opportunistic low-BMD risk flagging and referral support after radiograph review.
- Required input
- Standard frontal DICOM radiographs plus patient age and sex.
- Output and human action
- A positive or negative low-BMD report; positive reports are sent to PACS or a browser, while negative reports do not generate an output.
- Limitations
- The De Novo labeling states that Rho cannot rule out low BMD, absence of a report is not a negative result, and it does not replace DXA or clinical assessment. It is limited to the labeled radiograph types and adults aged 50 years and older.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The FDA De Novo materials describe DICOM radiograph input, PACS interface, and positive-result delivery to PACS or a browser.
- Deployment and data flow
- Not established in reviewed sources
The exact FDA decision material does not establish complete deployment topology, hosting responsibility, availability, upgrade, or service boundaries.
- Security and privacy
- Not established in reviewed sources
Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
- Training and support
- Use by radiologists and referring clinicians or other physician interpreters. Follow the exact labeling, local training, supervision, and escalation requirements.
- Monitoring and change control
- Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for DEN230023.
Deployment boundary
The exact public deployment boundary is incomplete; confirm hosting, data flow, availability, upgrades, security, service, and downtime locally.
exact submission · checked 2026-09-04Interoperability acceptance
The FDA De Novo materials describe DICOM radiograph input, PACS interface, and positive-result delivery to PACS or a browser.
exact submission · checked 2026-09-04Clinical acceptance
Test labeled population, acquisition quality, exclusions, failed inputs, reviewer overrides, and downstream effects for DEN230023.
exact submission · checked 2026-09-04Economic evaluation
Exact-product price, implementation cost, reimbursement, and total-cost evidence remain to be obtained; do not infer them from FDA clearance.
product family · checked 2026-09-04Lifecycle monitoring
Monitor labeling, software version, complaints, recalls, failed inputs, overrides, and postmarket signals against the exact submission and installed configuration.
exact submission · checked 2026-09-04Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- Evidence summary
- DEN230023 FDA decision material reports the exact evidence metrics included below for Rho; values are limited to the stated endpoint, population, and operating point.
- Reported sensitivity
- Not applicable
Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.
- Reported specificity
- Not applicable
Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.
TNI6 low-BMD sensitivity
0.67 proportionLow-BMD classification sensitivity in TNI6 validation dataset.
Tested version: RhoTNI6 low-BMD specificity
0.9 proportionLow-BMD classification specificity in TNI6 validation dataset.
Tested version: RhoOMN low-BMD sensitivity
0.45 proportionLow-BMD classification sensitivity in OMN validation dataset.
Tested version: RhoOAI low-BMD sensitivity
0.36 proportionLow-BMD classification sensitivity in OAI validation dataset.
Tested version: RhoDEN230023 FDA evidence package for Rho
FDA De Novo clinical validation across three radiographic datasets. · TNI6, OMN, and OAI radiographic validation datasets as tabulated in the FDA De Novo review.
exact submission · Tested version: Rho · 6 sites · Sponsor or vendor studyDEN230023
FDA tables include TNI6 n=3,729, OMN n=513, and OAI n=591; the De Novo record is the source anchor and linked FDA review contains detailed tables.
Economics and lifecycle
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Not established in reviewed sources
No public list price or commercial contract for the exact submission and version was identified.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer coverage or reimbursement determination was identified in reviewed public material.
No product-specific code
No exact-product reimbursement determination identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesThis public-policy review is not a coverage determination. Verify payer, site-of-service, coding, and local value assumptions independently.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
- Postmarket safety review
- No record matched DEN230023 by exact native submission identifier in the 2026-09-02 openFDA snapshot; this does not exclude product-family, later-version, or adverse-event information.
Buyer worksheet
Open questions to take to the vendor
- Verify deployment and data flow: The exact FDA decision material does not establish complete deployment topology, hosting responsibility, availability, upgrade, or service boundaries.
- Verify security and privacy controls: Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
- Verify pricing and total cost: No public list price or commercial contract for the exact submission and version was identified.
- Verify reimbursement and coding relevance: No exact-product payer coverage or reimbursement determination was identified in reviewed public material.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-04Last searched
27Fields reviewed
11Source classes checked
20Reviewed PubMed leads
10Reviewed trial leads
0Unreviewed FDA recall leads
No evidence was promoted. Every record concerns Rho biology or an unrelated clinical intervention and does not identify the 16 Bit Rho device or DEN230023. The current discovery snapshot contains 20 PubMed and 10 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Source ledger
Sources accessed through 2026-09-04.
- FDA De Novo record DEN230023: Rho U.S. Food and Drug Administration · 2026-09-04
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- Rho model card (DEN230023) American College of Radiology · 2026-09-01
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
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