CLARUS

K191194

Carl Zeiss Meditec, Inc · cleared 2019-06-25 · product code QER · Ophthalmic

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The CLARUS 700 is an active, software controlled, high-resolution ophthalmic imaging device for In-vivo imaging of the human eye. Imaging modes include True color, Fundus Auto-fluorescence with green excitation, Fundus Auto-fluorescence with blue excitation, Fluorescein Angiography, Stereo and External eye. All true color images can be separated into red, green and blue channel images to help enhance visual contrast of details in certain layers of the retina. The CLARUS 700 angiography imaging aids in the visualization of the vascular structures of the retina and the choroid. With a single capture, CLARUS 700 produces a 90° high definition widefield image. Widefield images are automatically merged to achieve a 135° ultra-widefield of view. The CLARUS 700 makes use of a deep learning algorithm for Optic Nerve Head (ONH) detection.”
Algorithmdeep learning algorithm for Optic Nerve Head (ONH) detection
source quote (p.5)
“The CLARUS 700 makes use of a deep learning algorithm for Optic Nerve Head (ONH) detection.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (10)

Bench

sample size not stated

endpoints: system compliance with established system requirements

Bench

sample size not stated

endpoints: customer acceptance of the intended use, features and the workflow; device meets the requirements set out by the Product Requirements Specifications; all aspects of the user experience met the acceptance criteria

Bench

sample size not stated

endpoints: conformity to multiple industry standards

Bench

sample size not stated

endpoints: compliance with ANSI AAMI 60601-1:2005/(R) 2012 and A1:2012 (Ed 3.1) standard

standards: ANSI AAMI 60601-1:2005/(R) 2012, A1:2012 (Ed 3.1)

Bench

sample size not stated

endpoints: compliance with IEC 60601-1-2:2014 Ed 4.0 standard

standards: IEC 60601-1-2:2014 Ed 4.0

Bench

sample size not stated

endpoints: demonstrated optical safety for Fluorescein Angiography imaging mode; hazard analysis assessment

standards: ANSI Z80.36-2016, ISO 15004-2:2007, IEC 60825-1:2007

Bench

sample size not stated

endpoints: evaluated for Biocompatibility and comply with requirements of ISO 10993-1:2009 standard

standards: ISO 10993-1:2009

Bench

sample size not stated

endpoints: compliance with the requirements for environmental conditions for use, storage and transport as specified in the ISO 15004-1:2009 standard

standards: ISO 15004-1:2009

Bench

sample size not stated

endpoints: software verification testing for the device was conducted and documentation is provided as recommended by the FDA's Guidance for Industry and FDA staff, “Guidance for the Content of premarket Submissions for Software Contained in Medical Devices.”

standards: FDA's Guidance for Industry and FDA staff, “Guidance for the Content of premarket Submissions for Software Contained in Medical Devices.”

Retrospective clinical

n=13 patients

endpoints: Area and lesion of interest is visible on the angiogram; Clinically useful image. Image appearance is consistent with the disease and transit phase of dye; Artifacts, if any, do not interfere with ability to interpret image

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
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243878 (decision 2025-04-17) from Carl Zeiss Meditec, Inc. for a matching device line ("CLARUS (700)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243878

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 Ophthalmic 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/K191194