← Product Code [KPR](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR) · K101686

# FDR IMAGE STITCHING OPTION (K101686)

_Fujifilm Medical System U.S.A., Inc. · KPR · Oct 29, 2010 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K101686

## Device Facts

- **Applicant:** Fujifilm Medical System U.S.A., Inc.
- **Product Code:** [KPR](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR.md)
- **Decision Date:** Oct 29, 2010
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 892.1680
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

## Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only 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/KPR/K101686](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K101686)

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