MICRO-MAX, MODEL 319

• K Number: K002404
• Device Name: MICRO-MAX, MODEL 319
• Manufacturer: TEK MARKETING, INC.
• Date Cleared: 2000-08-30 ( 23 days)
• Product Code: IXW
• Regulation Number: 892.1900
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 892.1900 Automatic radiographic film processor.

(a)
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.(b)
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.