OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

K203578

Perimeter Medical Imaging AI, Inc. · cleared 2021-02-25 · product code NQQ · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“The Perimeter OTIS™ 2.1 is an imaging tool for use on excised human tissue. The Perimeter OTIS™ 2.1 is based on optical coherence tomography (OCT) imaging, which is similar to ultrasound, but uses non-ionizing, low-power optical radiation to produce high resolution, sub-surface images of a tissue sample.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: outputs met design input requirements; Perimeter OTISTM 2.1 fulfilled the intended use and met user needs; safety of OTIS™ 2.1 in its intended environment

standards: ISO 10993-1:2009/(R)2013, ISO 10993-5:2009/(R)2014

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/K203578