(37 days)
Not Found
No
The description focuses on mechanical and chemical processes for film handling and processing, with software controlling these operations based on bar code information. There is no mention of AI or ML algorithms for image analysis, decision-making, or learning from data.
No.
The device is used for processing x-ray film, not for treating any medical condition or disease.
No
The device processes x-ray film used in diagnostic procedures but does not perform the diagnostic analysis itself. It is a film handling and processing system, not a diagnostic tool.
No
The device description clearly outlines a physical system involving mechanical rollers, guides, chemical replenishment, and a control panel, indicating it is a hardware-based system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for handling and processing x-ray films from radiographic, diagnostic procedures. This involves processing images of the body, not analyzing biological samples (like blood, urine, or tissue) to diagnose disease or other conditions.
- Device Description: The description reinforces that the device processes x-ray film. It mentions mechanical rollers, chemical replenishment, and software to control the processing of the film based on information encoded on the cassettes.
- Input Imaging Modality: The input is x-ray film, which is an imaging modality, not a biological sample.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device processes images captured on film, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The 3M Trimatic™ Modular Advanced Processing System is an automatic, modular system for unloading exposed x-ray film from x-ray film cassettes, processing the film, and reloading the empty x-ray film cassette with fresh x-ray film of the same size and type. The 3M Trimatic™ Modular APS will accommodate from four to seven different film types / sizes in film modules. This system is used for handling and processing of x-ray films from all general radiographic, diagnostic procedures which employ conventional x-ray film / screen technology. 3M Trimatic™ Modular APS provides remote diagnostic capability. The integrated automatic x-ray film processor can also be used as a stand-alone processor.
Product codes
Not Found
Device Description
The 3M Trimatic™ Modular Advanced Processing System is an automatic, modular system for unloading exposed x-ray film from x-ray film cassettes, processing the film, and reloading the empty x-ray film cassette with fresh x-ray film of the same size and type. The 3M Trimatic™ Modular APS will accommodate from four to seven different film types / sizes in film modules. This system is used for handling and processing of x-ray films from all general radiographic, diagnostic procedures which employ conventional x-ray film / screen technology. 3M Trimatic™ Modular APS provides remote diagnostic capability. The integrated automatic x-ray film processor can also be used as a stand-alone processor. The 3M Trimatic™ Modular APS can be fit with a "through-the-wall-kit" which will enable it to accept film from a darkroom. Both the subject device and the predicate use mechanical rollers, guides and drives and pneumatic means to move the x-ray film within the device. The subject device has moved and altered some of the internal mechanisms to reduce the size of the film magazine modules. The integrated automatic x-ray film processor in the subject device uses mechanical rollers and guides, chemical replenishment and chemical agitation methods which are similar to the predicate processor. The software used to control the operation of the subject device has added capabilities over the software used in the predicate device. Encoded in the bar codes on the x-ray film cassettes are the x-ray film size, type and the correct processing conditions for that particular film. This information drives the operation of the device. Remote diagnostics via phone line is also an added feature in the subject device. The control panel controls both the load / unload process and the automatic x-ray film processor. The predicate device has separate controls for each operating section of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray film / screen technology
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
Field test and internal qualification / validation tests.
Key Metrics
Not Found
Predicate Device(s)
3M Trimatic™ M Plus Daylight System - (510(k) K880565, 21 March 1988), 3M XP 515 X-Ray Film Processor (510(k) K880563, 21 March 1988)
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
AUG 21 1996
Image /page/0/Picture/2 description: The image shows the logo for Imation, a company that was spun off from 3M. The logo features a hand holding a wand, with stars and plus signs emanating from the wand. The text "IMATION" is written in large, bold letters, and the tagline "Borne of 3M Innovation" is written in smaller letters below.
Borne of 3M Innovation
Imation Enterprises Corp. 1 Imation Place Oakdale, MN 55128-3414 612 704 4000 phone 800 537 4675 fax
July 1, 1996
Imation Corp. 1 Imation Place Oakdale MN 55128 Contact: Stephen G. Slavens 3M Center, 235-2B-23 St. Paul MN 55144-1000
Phone: 612-736-9536 612-736-3116 FAX:
Device:
Trade name: 3M Trimatic™ Advanced Processing System 3M APS Automatic Film Processor
Common name: Modular x-ray film loading system with integrated automatic film processor Classification name: Modular film loader / unloader - Unknown Automatic radiographic film processor -21 CFR 892.1900 - Class II
510(k) Summary
Predicate Device:
3M Trimatic™ M Plus Daylight System - (510(k) K880565, 21 March 1988)
3M XP 515 X-Ray Film Processor (510(k) K880563, 21 March 1988).
Description and Intended Use of Device:
The 3M Trimatic™ Modular Advanced Processing System is an automatic, modular system for unloading exposed x-ray film from x-ray film cassettes, processing the film, and reloading the empty x-ray film cassette with fresh x-ray film of the same size and type. The 3M Trimatic™ Modular APS will accommodate from four to seven different film types / sizes in film modules. This system is used for handling and processing of x-ray films from all general radiographic, diagnostic procedures which employ conventional x-ray film / screen technology. 3M Trimatic™ Modular APS
1
provides remote diagnostic capability. The integrated automatic x-ray film processor can also be used as a stand-alone processor.
The 3M Trimatic™ Modular APS can be fit with a "through-the-wall-kit" which will enable it to accept film from a darkroom.
Technological Charactistics:
Both the subject device and the predicate use mechanical rollers, guides and drives and pneumatic means to move the x-ray film within the device. The subject device has moved and altered some of the internal mechanisms to reduce the size of the film magazine modules. The integrated automatic x-ray film processor in the subject device uses mechanical rollers and guides, chemical replenishment and chemical agitation methods which are similar to the predicate processor.
The software used to control the operation of the subject device has added capabilities over the software used in the predicate device. Encoded in the bar codes on the x-ray film cassettes are the x-ray film size, type and the correct processing conditions for that particular film. This information drives the operation of the device. Remote diagnostics via phone line is also an added feature in the subject device.
The control panel controls both the load / unload process and the automatic x-ray film processor. The predicate device has separate controls for each operating section of the device.
Performance Data:
Voluntary standards include: UL 122 IEC 950 IEC 801-2, 3, 4, 5 EN 22011 3M Trimatic™ APS Engineering Specification (Part B)
With the successful conclusion of both the field test and internal qualification / validation tests the software final release must be approved by the product team for production. After final approval, according to established procedures, the software label code will change to the production label.