3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR

K962750 · Imation Corp. · IXW · Aug 21, 1996 · Radiology

Device Facts

• Record ID: K962750
• Device Name: 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR
• Applicant: Imation Corp.
• Product Code: IXW · Radiology
• Decision Date: Aug 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1900
• Device Class: Class 2

Intended 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. The 3M Trimatic™ Modular APS can be fit with a “through-the-wall-kit” which will enable it to accept film from a darkroom.

Device Story

Modular system for automated x-ray film handling; unloads exposed film from cassettes, processes film, and reloads cassettes with fresh film. Accommodates 4-7 film sizes/types via film modules. Used in clinical radiology departments; operated by radiology staff. Inputs: exposed x-ray film cassettes with bar-coded metadata (film size, type, processing conditions). Processing: mechanical rollers, guides, pneumatic transport, chemical replenishment, and agitation. Outputs: processed diagnostic x-ray film. Features remote diagnostic capability via phone line; integrated processor functions as stand-alone unit. Through-the-wall kit allows darkroom integration. Benefits: automated workflow, reduced manual handling, standardized processing conditions based on bar-coded film data.

Clinical Evidence

Bench testing only. Validation included internal qualification tests and field testing to verify system performance and software functionality against engineering specifications.

Technological Characteristics

Modular film loader/unloader and automatic processor. Mechanical transport via rollers, guides, and pneumatic systems. Chemical replenishment and agitation. Connectivity: phone line for remote diagnostics. Standards: UL 122, IEC 950, IEC 801-2/3/4/5, EN 55011. Software-controlled operation based on bar-coded cassette data.

Indications for Use

Indicated for handling and processing of x-ray films from all general radiographic, diagnostic procedures employing conventional x-ray film/screen technology.

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

• 3M Trimatic™ M Plus Daylight System (K880565)
• 3M XP 515 X-Ray Film Processor (K880563)

Submission Summary (Full Text)

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K96 2750

AUG 21 1996

IMMATION

Borne of 3M Innovation

# 510(k) Summary

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: [phone]
FAX: [phone]

## 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

## 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

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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 Characteristics:

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 55011
- 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.