(16 days)
K913241/A
K913241/A
No
The device description details a film processor with tanks and dimensions, with no mention of AI, ML, image processing, or data analysis.
No.
The device is a film processor for developing cineangiogram films, which is part of the imaging workflow and not used for treating medical conditions.
No
The device is described as a "cine film processor" that develops "cineangiogram films." Its function is to process film, not to diagnose medical conditions. Processing film is an intermediate step in imaging, but the device itself does not perform any diagnostic interpretation or analysis.
No
The device description clearly describes a physical film processor with tanks and dimensions, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on processing film, specifically cineangiogram films. There is no indication that this device is used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Focus on film processing: The device is described as a "cine film processor" with tanks for developing, fixing, washing, and drying film. This is a process applied to a physical medium (film) rather than a biological sample.
- Intended Use/Indications for Use is "Not Found": While this field is missing, the device description itself does not suggest an IVD use.
- Predicate Device: The predicate device listed (Jamieson JT/Kodak Ektacath) is also a film processor, further supporting the conclusion that this device is for film processing, not in vitro diagnostics.
Therefore, the Model 2100 is a device used in the process of developing medical images captured on film, not a device that performs in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K913241/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K 96334
Image /page/0/Picture/1 description: The image shows the text "SEP 11 1998". The text is written in a bold, sans-serif font. The letters are slightly distorted, as if they were stamped or printed with a worn-out stamp. The text is arranged horizontally, with the month abbreviation "SEP" on the left, followed by the day "11", and then the year "1998" on the right.
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.