← Product Code [LMC](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMC) · K930755

# ULTRA COMPACT VIDEO IMAGER (K930755)

_International Imaging Electronics · LMC · Sep 28, 1993 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMC/K930755

## Device Facts

- **Applicant:** International Imaging Electronics
- **Product Code:** [LMC](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMC.md)
- **Decision Date:** Sep 28, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.2040
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.

## Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMC/K930755](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMC/K930755)

**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