TENET RADIOLUCENT HAND TABLE

• K Number: K963506
• Device Name: TENET RADIOLUCENT HAND TABLE
• Manufacturer: TENET MEDICAL ENGINEERING
• Date Cleared: 1997-01-09 ( 128 days)
• Product Code: FQO FWW GDC
• Regulation Number: 878.4960

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 878.4960 Operating tables and accessories and operating chairs and accessories.

(a)
Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Summary

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