JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100

K963334 · Jamieson Film Co. · IXX · Sep 11, 1996 · Radiology

Device Facts

• Record ID: K963334
• Device Name: JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100
• Applicant: Jamieson Film Co.
• Product Code: IXX · Radiology
• Decision Date: Sep 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1900
• Device Class: Class 2

Intended Use

The Model 2100 is a leader card black-and-white 35 mm cine film processor, most commonly used for developing cineangiogram films.

Device Story

Leader card 35 mm cine film processor; processes cineangiogram films. System comprises four tanks: developer, fixer, wash, and dryer. Used in clinical environments for radiographic film development. Modifications include electrical/safety updates for CE Medical Device Directive compliance and minor transport assembly adjustments. Device automates film processing workflow; supports diagnostic imaging by preparing cineangiogram film for physician review.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Automatic radiographic film processor; 35 mm cine film format. Dimensions: 58.5" L x 17" W x 43" H. Four-tank system (developer, fixer, wash, dryer). Electrical/safety compliant with CE Medical Device Directive.

Indications for Use

Indicated for the development of 35 mm black-and-white cineangiogram film in a clinical setting.

Regulatory Classification

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.

Predicate Devices

• Jamieson JT/Kodak Ektacath (K913241/A)

Submission Summary (Full Text)

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K 96 3334

SEP 11 1998

# Summary of Safety and Efficacy

510(k) Summary for the Jamieson Model 2100 Cine Processor and the Kodak Cineflure Processor Model 2100

This summary of 510(k) safety and efficacy information is being submitted in compliance with the requirements of SMDA 1990 and 21 CFR 807.92.

## Submitter's Name

Jamieson Film Company
10425 Olympic Drive
Dallas, TX 75220-4427
Contact: George Leon, Product Line Manager
Phone: [phone]
Fax: [phone]

## Device Name and Classification

Trade name: Jamieson Model 2100 Cine Processor
Kodak Cineflure Processor Model 2100
Common Name: Black-and-white 35 mm cine film processor
Classification: Class II, Automatic Radiographic Film Processor, 21 CFR 892.1900

## Predicate Device

The Model 2100 is substantially equivalent to the Jamieson JT/Kodak Ektacath, accepted on September 24, 1991, K# K913241/A.

## Description of the Model 2100

The Model 2100 is a leader card black-and-white 35 mm cine film processor, most commonly used for developing cineangiogram films. The Model 2100 has four (4) tanks, the developer, fixer, wash, and dryer tanks. The Model 2100 is 58.5 inches long, 17 inches wide, and 43 inches high.

The Model 2100 has been altered to meet the electrical and safety requirements of the CE Medical Device Directive. Some minor modifications have been made to the transport assembly as well in response to customer preferences. None of the changes made adversely affect the safety or efficacy of the processor or can be considered new indications of use.

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