← Product Code [IYW](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYW) · K780395

# IMAGER, BODY SECTION, RADIONUCLIDE (K780395)

_Union Carbide Corp. · IYW · Mar 31, 1978 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYW/K780395

## Device Facts

- **Applicant:** Union Carbide Corp.
- **Product Code:** [IYW](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYW.md)
- **Decision Date:** Mar 31, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1300
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory Identification

A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in the body by means of a detector (or detectors) whose position moves in two directions 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/IYW/K780395](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYW/K780395)

**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