← Product Code [IXW](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW) · K954345

# DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR (K954345)

_Doosan Corp. · IXW · Oct 18, 1995 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K954345

## Device Facts

- **Applicant:** Doosan Corp.
- **Product Code:** [IXW](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW.md)
- **Decision Date:** Oct 18, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1900
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.

## Special Controls

*Classification.* Class II (special controls). 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/IXW/K954345](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K954345)

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