CLARUS (700)

K243878

Carl Zeiss Meditec, Inc. · cleared 2025-04-17 · product code QER · Ophthalmic

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.7)
“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 External eye and Fluorescein Angiography- Indocyanine green angiography (FA-ICGA). 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 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.7)
“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 (5)

Bench

sample size not stated

standards: ISO 10993-1

Bench

sample size not stated

standards: ANSI/AAMI ES60601-1:2005/(R) 2012, ANSI Z80.36-2021, IEC 60601-1-2:2014, IEC 60825-1:2007, IEC 60601-2-22:2012, IEC 62133: 2012

Bench

sample size not stated

standards: FDA's Guidance for Industry and FDA Staff, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Bench

sample size not stated

Retrospective clinical

sample size not stated

endpoints: demonstrating the ability of the new model of CLARUS 700 to image a variety of retinal and choroidal conditions using simultaneous FA and simultaneous ICGA and standalone ICGA; quality of the images captured by the CLARUS 700 simultaneous FA, simultaneous ICGA, and standalone ICGA were clinically acceptable

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
0
drift signals on this device

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/K243878