Constellation (CON-001)

K241280

Q Bio, Inc. · cleared 2024-09-12 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Constellation is an automated image post-processing software application used in a clinical MRI setting.”
AlgorithmNon-AI based Algorithms (brain, lungs, femur, lower limb muscles, SAT) Convolutional neural networks (kidneys, spleen, liver, VAT)
source quote (p.9)
“Non-AI based Algorithms (brain, lungs, femur, lower limb muscles, SAT) Convolutional neural networks (kidneys, spleen, liver, VAT)”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (3)

Retrospective clinical

sample size not stated

endpoints: Segmentation accuracy of the lungs, liver, spleen, kidneys, muscle, and fat (visceral and subcutaneous); Segmentation accuracy for brain cortical/subcortical regions

Reader study (MRMC)

sample size not stated

endpoints: Liver Volume of Interest (VOI) placement

Bench

sample size not stated

endpoints: Device repeatability; Test-retest measurement repeatability; Software verification testing; Software usability testing

standards: General Principles of Software Validation, Guidance for Industry and FDA Staff, Applying Human Factors and Usability Engineering to Medical Devices

Reported performance (1 observation)

diceas written: “Dice Similarity Coefficient (DSC)”stated without value
source quote (p.12)
“Segmentation accuracy of the lungs, liver, spleen, kidneys, muscle, and fat (visceral and subcutaneous) is evaluated using the Dice Similarity Coefficient (DSC) and mean percent absolute difference as primary and secondary figures of merit (FOM).”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K241280