OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
K210458Abbott Medical · cleared 2021-06-08 · product code NQQ · Radiology
Premarket evidence — what FDA accepted
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). ... Modifications to the Ultreon 1.0 software have been made to include automated 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”
source quote (p.7)
“Software updates were made to the following existing features: ... Cybersecurity ... Trusted Platform Module (TPM) chip supporting cybersecurity”
Validation studies (3)
Bench
sample size not stated
endpoints: to ensure that the subject device meets requirements and functions as intended
Bench
sample size not stated
endpoints: to demonstrate that the updated user interface, 1) does not trigger any serious harm based on use error or use problems, for the intended uses, and under the expected use conditions; and, 2) shows no pattern of use errors or problems that could result in serious harm and that could be eliminated or reduced through further modification of the user interface, device labeling, or user training.
Bench
sample size not stated
endpoints: to demonstrate that the OPTIS Next Imaging System products and packaging meet specifications, are appropriate for their intended use, and do not raise new questions of safety or effectiveness.
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
- 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). 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).