CLARUS (700)

Carl Zeiss Meditec, Inc. • Ophthalmic • 04/17/2025

510(k)IEC 62304 Class B

Device Purpose

The Carl Zeiss Meditec Clarus (700) ophthalmic camera is designed to facilitate the diagnosis and monitoring of retinal, ocular surface, and adnexal diseases by capturing high-resolution true color, fundus autofluorescence, and multimodal angiography images. Its upgraded version (v1.2) incorporates simultaneous Fluorescein and Indocyanine Green Angiography and movie capture, with comprehensive testing validating its safety, performance, and substantial equivalence to predicate devices for visualizing ocular vascular structures.

Summary

Carl Zeiss Meditec, Inc. has received a determination allowing them to market their Clarus (700) ophthalmic camera. This determination concluded that the device is substantially equivalent to a previously marketed device for its intended use. The camera is designed to capture, display, annotate, and store images, thereby aiding in the diagnosis and monitoring of diseases and disorders affecting the retina, ocular surface, and visible adnexa, and is specifically for prescription use. The Clarus (700) system is a high-resolution ophthalmic imaging device that offers various modes, including true color, fundus autofluorescence, and fluorescein angiography. This updated version (v1.2) introduces new capabilities such as simultaneous Fluorescein Angiography and Indocyanine Green Angiography (ICGA) and angiography movie capture, supported by specific hardware and software modifications. Comprehensive testing, including biocompatibility, laser and electrical safety, software verification, bench testing, and clinical evaluations, confirmed the device's performance, safety, and equivalence to its predicate, ensuring its ability to produce high-quality images for visualizing vascular structures of the retina and choroid.

AI Regulatory Concerns

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

Carl Zeiss MeditecClarus (700)Ophthalmic imagingRetinaFundus autofluorescenceFluorescein AngiographyIndocyanine Green AngiographyHigh-resolutionDiagnosisMedical device

Device Metadata

Submission Number

K243878

Company

Carl Zeiss Meditec, Inc.

Panel

Ophthalmic

Product Code

N/A

Data Type

N/A

Clinical Function

N/A

AI Function

N/A

AI Subclass

N/A

Relevant Clinical Questions

Q1. What specific clinical scenarios benefit most from the simultaneous Fluorescein Angiography and Indocyanine Green Angiography capabilities of the Clarus (700)?; How does the new angiography movie capture feature enhance diagnostic accuracy or patient management compared to still image capture?; Are there any notable improvements in image resolution or field of view with the Clarus (700) v1.2, particularly concerning peripheral retinal imaging?; What specific data on clinical evaluations and biocompatibility testing support the device's long-term safety profile for repeated patient use?; Can the Clarus (700) integrate with existing electronic health record (EHR) systems for streamlined image storage and data analysis?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Post-§524B but no clear network capability detected

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Cybersecurity Evidence

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score20/100

SBOM Evidence⚠ Not in summary - likely in full submission per §524B

Cyber Risk Assessment⚠ Not in summary - likely in full submission per §524B

Postmarket Plan✓ Detected in Summary

§524B ApplicableYes

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials

- Not detected

ML-BOMMachine Learning Bill of Materials

- Not detected

SaaSBOMSoftware-as-a-Service Bill of Materials

- Not detected

HBOMHardware Bill of Materials(hardware, camera)

✓ Detected

CBOMCryptography Bill of Materials

- Not detected

VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange

- Not detected

OBOMOperations Bill of Materials

- Not detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of HBOM detected in AI-generated device summary.

• SBOM not mentioned in AI-generated device summary. Under §524B (effective Oct 2023), cyber devices must provide a SBOM.

• Cybersecurity risk assessment not referenced in AI-generated device summary. FDA cybersecurity guidance (2023) expects this for cyber devices.

• Not detected in AI-generated device summary: SBOM, ML-BOM, SaaSBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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