# Instrument Manager - 8.10.01 (BK100046)

_Data Innovations LLC · Aug 12, 2010 · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/BK100046

## Device Facts

- **Applicant:** Data Innovations LLC
- **Decision Date:** Aug 12, 2010
- **Decision:** SESE

---

**Source:** [https://fda-staging.innolitics.com/device/BK100046](https://fda-staging.innolitics.com/device/BK100046)

**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