← Product Code [JWM](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM) · K780368

# MODUMED MUGX (K780368)

_Medtronic Vascular · JWM · Mar 14, 1978 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM/K780368

## Device Facts

- **Applicant:** Medtronic Vascular
- **Product Code:** [JWM](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM.md)
- **Decision Date:** Mar 14, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1310
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A nuclear tomography system is a device intended to detect nuclear radiation in the body and produce images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of devices may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM/K780368](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM/K780368)

**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