OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

K210458

Abbott Medical · cleared 2021-06-08 · product code NQQ · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“The OPTISTM Mobile Next Imaging System is comprised of a cart-mounted personal computer, imaging engine, and power supply that are placed inside an ergonomically designed mobile cart. This system includes a keyboard, display monitors, mouse, tableside controller, and a Drive-motor and Optical Controller (DOC). The OPTIST™ Integrated Next is comprised of a PC, imaging engine, and power supply that are housed in stationary cabinet which is located in the clinic/hospital equipment closet of a catheter lab. The tableside controller, DOC and DOC Holster are located in the procedure room, and the keyboard, display monitor, and mouse are located in the control room. Modifications to the Ultreon 1.0 software have been made to include automated morphology assessment of External Elastic Lamina (EEL) and calcium, display of live angiography imagery on the OPTIS Next Imaging System display monitors, and user interface guided workflows for image data acquisition and review.”
Algorithmautomated morphology assessment of External Elastic Lamina (EEL) and calcium
source quote (p.7)
“Modifications to the Ultreon 1.0 software have been made to include automated morphology assessment of External Elastic Lamina (EEL) and calcium, display of live angiography imagery on the OPTIS Next Imaging System display monitors, and user interface guided workflows for image data acquisition and review.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.7)
“Modifications to the Ultreon 1.0 software have been made to include automated morphology assessment of External Elastic Lamina (EEL) and calcium, display of live angiography imagery on the OPTIS Next Imaging System display monitors, and user interface guided workflows for image data acquisition and review. Software updates were made to the following existing features: [...] Cybersecurity. Trusted Platform Module (TPM) chip supporting cybersecurity. Modifications to the OPTIS Mobile Next, OPTIS Integrated Next Hardware have been made to support of the computational speed, display, electrical compliance, and cybersecurity requirements of the system.”

Validation studies (1)

Retrospective clinical

n=2,500 patients

endpoints: clinical accuracy and outcomes; diagnostic and prognostic performance; ischemia detection

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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
13
MAUDE reports in code, 12mo
+179%
vs code's own 3-yr baseline
1
drift signals on this device
  • adverse_event_inflection

    MAUDE adverse-event reports for product code NQQ: 13 in the 12 months ending 2026-06, vs a 4.7/12mo average over the prior 3 windows (+179%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=NQQ

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/K210458