← Product Code [DXG](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG) · K772158

# LIGHT-PEN SYSTEM FOR QUANTI. ANALY. (K772158)

_Varian Assoc., Inc. · DXG · Nov 22, 1977 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K772158

## Device Facts

- **Applicant:** Varian Assoc., Inc.
- **Product Code:** [DXG](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG.md)
- **Decision Date:** Nov 22, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1435
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K772158](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K772158)

**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