Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart G — Assisted Reproduction Devices](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices) → [21 CFR 884.6190](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/884.6190) → MTX — Microscope And Microscope Accessories, Reproduction, Assisted

# MTX · Microscope And Microscope Accessories, Reproduction, Assisted

_Obstetrics/Gynecology · 21 CFR 884.6190 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MTX

## Overview

- **Product Code:** MTX
- **Device Name:** Microscope And Microscope Accessories, Reproduction, Assisted
- **Regulation:** [21 CFR 884.6190](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/884.6190)
- **Device Class:** 1
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## Identification

Assisted reproduction microscopes and microscope accessories (excluding microscope stage warmers, which are classified under assisted reproduction accessories) are optical instruments used to enlarge images of gametes or embryos. Variations of microscopes and accessories used for these purposes would include phase contrast microscopes, dissecting microscopes and inverted stage microscopes.

## Classification Rationale

Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

---

**Source:** [https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MTX](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MTX)

**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