IMATION TRIMATIC DIGITAL SYSTEM

K984252 · Imation Corp. · LMA · Jan 25, 1999 · Radiology

Device Facts

• Record ID: K984252
• Device Name: IMATION TRIMATIC DIGITAL SYSTEM
• Applicant: Imation Corp.
• Product Code: LMA · Radiology
• Decision Date: Jan 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

The Imation™ Trimatic™ Digital System is intended for use an automated system to convert radiographic films into a DICOM format image for use in a hospital or other clinical Image Management System(IMS). The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-ray films.

Device Story

The Imation™ Trimatic™ Digital System is a film digitizer used in hospital or clinical environments. It accepts standard and mammographic radiographic films as input. A laser scanner digitizes the film, producing a 12-bit digital image in DICOM 3.0 format. The system adjusts scan rate and spot size based on film type to achieve 5 or 10 line pairs per mm resolution. The digitized images are forwarded to a DICOM-compliant image management system for review by medical practitioners. The device does not monitor patient status or provide automated diagnosis; it serves as a tool for clinical image management, facilitating digital storage and retrieval of radiographic data.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through conformance to voluntary design standards including UL1950, IEC825 (laser safety), and various EN/IEC electromagnetic compatibility and immunity standards.

Technological Characteristics

Laser scanner digitizer; 12-bit image depth; DICOM 3.0 output. Resolution: 5 lp/mm (standard) or 10 lp/mm (mammographic). Standards: UL1950, 21 CFR 1040, IEC825, EN60601-1-2, EN55011, EN55014-1, EN61000-4-2/3/4/5/6/8/11, ENV 50204.

Indications for Use

Indicated for use in hospital or clinical settings to convert standard and mammographic radiographic films into digital DICOM format for image management systems.

Regulatory Classification

Identification

A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). 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

• K982785

Submission Summary (Full Text)

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JAN 25 1999

Image /page/0/Picture/1 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 a trail of plus signs and dots emanating from the wand. The text "IMATION" is written in a bold, sans-serif font below the wand and hand. The phrase "Borne of 3M Innovation" is written in a smaller font below the company name.

Imation Corp. 1 Imation Place Oakdale, MN 55128-3414 612 704 4000 phone [phone] fax

# 510(k) Summary

Nov 25, 1998

Imation Corp. 1 Imation Place Oakdale MN 55128-3414 Contact: Stephen G. Slavens 1 Imation Way DIS-4B-75 Oakdale MN 55144-3414 Phone: [phone] FAX: [phone]

| Device: | Trade name: | Imation™ Trimatic™ Digital System |
|---------|----------------------|-----------------------------------|
| | Common name: | PACS System |
| | Classification name: | Image Processing System LLZ |
| | | 21 CFR 892.2020 Class II |

#### Predicate device:

The Imation™ Trimatic Digital System is comprised of cleared or exempt devices with the exception of the digitizer, which is identical to the digitizer in clearance (K982785) except for minor film feeding hardware and communication software.

#### Description and Intended Use of Device:

The Imation™ Trimatic™ Digital System is intended for use as a system to convert radiographic films into a digitized format for use in a hospital or other clinical image management system. The digitized image receives patient and exam information and is then forwarded into a DICOM compliant image management system. The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-rays.

#### Technological Characteristics:

The Imation™ Trimatic™ Film Digitizer uses a laser scanner to scan and digitize the film image. The digital image has 12 bit image depth and is in Dicom 3.0 format. The scan rate and spot size are adjusted depending on the film type to accurately capture either 5 or 10 line pairs per mm for standard and mammographic films, respectively.

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## Performance Data:

| Voluntary standards used in the design of the subject device(s) are: | | |
|----------------------------------------------------------------------|---------|--------------------------------------------|
| UL1950 | | Safety of Information Technology Equipment |
| 21 CFR1040 | | Laser Safety Standards |
| IEC825 | | Laser Safety Standards |
| EN60601-1-2 Class A | | Electro-Magnetic Compatibility |
| EN55011 | 1991-97 | Radiated and Conducted Immunity |
| EN55014-1 | 1993-97 | Conducted Immunity |
| EN61000-4-2 | 1995 | Electro-Static Discharge |
| EN61000-4-3 | 1996 | Radiated Radio-frequency |
| ENV 50204 | 1995 | Immunity to RF Telephone Emissions |
| EN61000-4-4 | 1995 | Electronic Fast Transfer |
| EN61000-4-5 | 1995 | Surge |
| EN61000-4-6 | 1996 | Conducted immunity |
| EN61000-4-8 | 1993 | Power Frequency Magnetic Field |
| EN61000-4-11 | 1994 | Power Line Fluctuation |

### Conclusion:

The Imation™ Trimatic™ Digital Imaging System has no patient contact, does not control or monitor patient medical status. Digital images generated by the Trimatic Digital System are interpreted by competent medical practitioners, offering ample opportunity for competent human intervention where warranted.

Imation believes the subject device is safe and effective based on comparison to the predicate device, on prior clearance of devices incorporated in this system and by conformance to the above design standards.

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- 2017-02-04 11:12:13

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 25 1999

Stephen G. Slavens Regulatory Affairs Manager Imation Corp. 1 Imation Place Oakdale, MN 55128-3414

Re: K984252

> Imation™ Trimatic™ Digital System Dated: November 25, 1998 Received: November 27, 1998 Regualtory class: II 21 CFR 892.2030/Procode: 90 LMA

Dear Mr. Slavens:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also. please note the requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# ATTACHMENT 2

Statement of Indications for Use:

| 510(K) Number (if known): | K984252 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: Imation™ Trimatic™ Digital System

Indications for Use:

The Imation™ Trimatic™ Digital System is intended for use an automated system to convert radiographic films into a DICOM format image for use in a hospital or other clinical Image Management System(IMS). The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-ray films.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X (Per 21 CFR 801.109) OR

Over-the- Counter Use_

David C. Seaman

(Division Sign-Off) ovision of Reproductive, Abdominal, El ud Radiological Vk) Number