Second Opinion® 3D

K243989

Pearl, Inc. · cleared 2025-05-23 · product code QIH · Radiology

FDA 510(k) summary for Second Opinion® 3D (K243989)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
1
Performance observations
7
Product code
QIH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.9)
“The device is a software-only device, so most testable characteristics common to other device types, including Biocompatibility/Materials, Shelf Life/Sterility, Electromagnetic Compatibility and Electrical Safety, Magnetic Resonance (MR) Compatibility, are not applicable to this device.”
Algorithmcomputer vision neural network algorithms, developed from open-source models using supervised machine learning techniques
source quote (p.8)
“Utilizes computer vision neural network algorithms, developed from open-source models using supervised machine learning techniques”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.9)
“Pearl developed Security controls and processes in accordance with FDA Guidance - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions dated September 2023. These processes are used in both the development of Second Opinion® 3D and in post-market surveillance to ensure the product upholds the highest standards of privacy and security.”

Validation studies (1)

Bench

n=100 images

endpoints: segmentation accuracy

Reported performance (7 observations)

diceas written: “Mean Dice Similarity Coefficient for Dentition”0.86CI 0.83, 0.89
source quote (p.10)
“Dentition 0.86 (0.83, 0.89)”
diceas written: “Mean Dice Similarity Coefficient for Maxillary Complex”0.91CI 0.91, 0.92
source quote (p.10)
“Maxillary Complex 0.91 (0.91, 0.92)”
diceas written: “Mean Dice Similarity Coefficient for Mandible”0.97CI 0.97, 0.97
source quote (p.10)
“Mandible 0.97 (0.97, 0.97)”
diceas written: “Mean Dice Similarity Coefficient for IAN Canal”0.76CI 0.74, 0.78
source quote (p.10)
“IAN Canal 0.76 (0.74, 0.78)”
diceas written: “Mean Dice Similarity Coefficient for Maxillary Sinus”0.97CI 0.97, 0.98
source quote (p.10)
“Maxillary Sinus 0.97 (0.97, 0.98)”
diceas written: “Mean Dice Similarity Coefficient for Nasal Space”0.9CI 0.89, 0.91
source quote (p.10)
“Nasal Space 0.9 (0.89, 0.91)”
diceas written: “Mean Dice Similarity Coefficient for Airway”0.95CI 0.94, 0.96
source quote (p.10)
“Airway 0.95 (0.94, 0.96)”

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

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
3
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250525 (decision 2025-11-14) from Pearl, Inc. for a matching device line ("Second Opinion® Panoramic") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250525

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243234 (decision 2025-06-12) from Pearl Inc. for a matching device line ("Second Opinion® CS") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243234

  • recall_reason_pattern

    Software/algorithm-related recall in product code QIH (PIE Medical Imaging B.V., initiated 2026-05-07): "User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:98930

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 2026-08-26.

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.

Related FDA clearances

More AI/ML devices under product code QIH

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243989