← Product Code [IYX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX) · K052473

# CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 (K052473)

_Inter Medical Medizintechnik GmbH · IYX · Oct 28, 2005 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K052473

## Device Facts

- **Applicant:** Inter Medical Medizintechnik GmbH
- **Product Code:** [IYX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX.md)
- **Decision Date:** Oct 28, 2005
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1100
- **Device Class:** Class 1
- **Review Panel:** Radiology
- **Attributes:** 3rd-Party Reviewed

## Regulatory Identification

A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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/IYX/K052473](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYX/K052473)

**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
