← Product Code [OWB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB) · K002016

# PHILIPS INTEGRIS ALLURA (K002016)

_Philips Medical Systems North America, Inc. · OWB · Sep 6, 2000 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K002016

## Device Facts

- **Applicant:** Philips Medical Systems North America, Inc.
- **Product Code:** [OWB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB.md)
- **Decision Date:** Sep 6, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1650
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression 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/OWB/K002016](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K002016)

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