← Product Code [IXL](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL) · K800554

# MULTI-FORMAT SFD MODEL 1720 (K800554)

_Philips Medical Systems (Cleveland), Inc. · IXL · Apr 10, 1980 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL/K800554

## Device Facts

- **Applicant:** Philips Medical Systems (Cleveland), Inc.
- **Product Code:** [IXL](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL.md)
- **Decision Date:** Apr 10, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1670
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy.

## 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/IXL/K800554](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL/K800554)

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