# SoftDonor Version 4.5.5.0 - 4.5.5.0 (BK210607)

_SCC Soft Computer · Sep 14, 2021 · SESE_

**Canonical URL:** https://fda.innolitics.com/device/BK210607

## Device Facts

- **Applicant:** SCC Soft Computer
- **Decision Date:** Sep 14, 2021
- **Decision:** SESE

---

**Source:** [https://fda.innolitics.com/device/BK210607](https://fda.innolitics.com/device/BK210607)

**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
