← Product Code [IXX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXX) · K963334 # JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100 (K963334) _Jamieson Film Co. · IXX · Sep 11, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXX/K963334 ## Device Facts - **Applicant:** Jamieson Film Co. - **Product Code:** [IXX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXX.md) - **Decision Date:** Sep 11, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1900 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for 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. ## Regulatory 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](/device/K913241.md)/A) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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: (214) 350-1293 Fax: (214) 357-2170 ## 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. 7 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXX/K963334](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXX/K963334) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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