← Product Code [JAM](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAM) · K841996

# MAXICAMERA 400T W/BODY CONTOUR TOMOGRA (K841996)

_General Electric Co. · JAM · Jul 16, 1984 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAM/K841996

## Device Facts

- **Applicant:** General Electric Co.
- **Product Code:** [JAM](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAM.md)
- **Decision Date:** Jul 16, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1330
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory Identification

A nuclear whole body scanner is a device intended to measure and image the distribution of radionuclides in the body by means of a wide-aperture detector whose position moves in one direction with respect to the patient. This generic type of device 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/JAM/K841996](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAM/K841996)

**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