← Product Code [KPS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS) · K010509

# CEDARS-SINAI BPGS AND MOCO (K010509)

_Smv America · KPS · Apr 27, 2001 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS/K010509

## Device Facts

- **Applicant:** Smv America
- **Product Code:** [KPS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS.md)
- **Decision Date:** Apr 27, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1200
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. 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/KPS/K010509](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPS/K010509)

**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