← Product Code [LMA](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA) · K011049

# EXPRESSSUITE (K011049)

_Vidar Systems Corp. · LMA · Oct 1, 2001 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K011049

## Device Facts

- **Applicant:** Vidar Systems Corp.
- **Product Code:** [LMA](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA.md)
- **Decision Date:** Oct 1, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.2030
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

## Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). 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.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K011049](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K011049)

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