# MRK · System, Imaging, Fluorescence

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/EN-misc/MRK

## Overview

- **Product Code:** MRK
- **Device Name:** System, Imaging, Fluorescence
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P020008](https://fda.innolitics.com/submissions/EN/EN-misc/MRK/P020008.md) | KARL STORZ AUTOFLUORESCENCE SYSTEM | KARL STORZ Endoscopy-America, Inc. | Dec 12, 2002 | APWD |
| [P950042](https://fda.innolitics.com/submissions/EN/EN-misc/MRK/P950042.md) | PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA | Novadaq Technologies, Inc. | Sep 19, 1996 | APPR |

## Top Applicants

- KARL STORZ Endoscopy-America, Inc. — 1 clearance
- Novadaq Technologies, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/EN/EN-misc/MRK](https://fda.innolitics.com/submissions/EN/EN-misc/MRK)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com