OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
K203578Perimeter Medical Imaging AI, Inc. · cleared 2021-02-25 · product code NQQ · Radiology
Premarket evidence — what FDA accepted
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.”
Validation studies (1)
Bench
sample size not stated
endpoints: outputs met design input requirements; fulfilled the intended use and met user needs; safety of OTIS™ 2.1 in its intended environment
standards: ANSI AAMI ISO 14971:2007/(R)2010, AAMI ANSI ES 60601-1:2005/(R)2012, A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, IEC 60601-1-2 Edition 4.0 2014-02, IEC 60825-1:2007, ANSI AAMI ISO 10993-1:2009/(R)2013, ANSI AAMI ISO 10993-5:2009/(R)2014, IEC 62304:2006/A1:2015
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).