IMATION SE-204 LASER IMAGER

K972822 · Imation Enterprises Corp. · LMC · Nov 19, 1997 · Radiology

Device Facts

• Record ID: K972822
• Device Name: IMATION SE-204 LASER IMAGER
• Applicant: Imation Enterprises Corp.
• Product Code: LMC · Radiology
• Decision Date: Nov 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2040
• Device Class: Class 2

Intended Use

The Imation™ SE-204 laser imager is intended use as a high resolution hard copy device for output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the SE-204 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities, including, but not limited to Digital Radiography and full view digital mammography for diagnostic use by medical radiologists and communications to referring physicians and their patients.

Device Story

Imation SE-204 Laser Imager functions as high-resolution hard copy output device for digital medical imaging modalities. Device receives electronic image signals from modalities (e.g., digital radiography, mammography) via Image Management System (IMS). System transforms signals optically to expose Imation imaging media; media transported through integrated processor to produce final film. Operated by medical personnel in clinical settings. Includes Automated Image Quality Control (AIQC) to match printing power with film characteristics, ensuring consistent image quality. Output used by radiologists for diagnosis and communication with referring physicians and patients. Device does not contact patients or control/monitor other medical devices; human intervention remains integral to diagnostic process.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness demonstrated through internal qualification, validation, and reliability testing, and adherence to voluntary standards (IEC601-1, IEC601-1-1, IEC601-1-2, UL2601). Performance metrics focused on spatial resolution and consistency of output density via AIQC.

Technological Characteristics

Laser printer for medical imaging. Uses daylight cartridges for imaging media. Integrated processor for film development. Connectivity via host control or keypad. Software-controlled image management and machine functions. AIQC system for density control. Complies with IEC601-1, IEC601-1-1, IEC601-1-2, and UL2601 standards.

Indications for Use

Indicated for medical radiologists and referring physicians to produce high-resolution hard copy diagnostic images from digital modalities, including digital radiography and full-view digital mammography, for diagnostic use and patient communication.

Regulatory Classification

Identification

A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). 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(Imation™) 8300 Laser Imager (K936152)
• Agfa LR 5200 Laser Film Recorder (K964414)

Submission Summary (Full Text)

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### K972822 510(k) Summary NOV 1 9 1997

Magnetic Resonance Diagnostic Device

July 28, 1997

| Imation Corp. | | Contact: Stephen G. Slavens | |
|---------------------|------------------------------|-----------------------------|--|
| 1 Imation Place | | 3M Center, 235-2B-23 | |
| Oakdale MN 55128 | | St. Paul MN 55144-1000 | |
| | | Phone: [phone] | |
| | | FAX: [phone] | |
| Device: Trade name: | Imation™ SE-204 Laser Imager | | |
| Common name: | Laser Printer | | |

3M(Imation™) 8300 Laser Imager(K936152) Predicate devices: Agfa LR 5200 Laser Film Recorder(K964414)

#### Description And Intended Use of Device:

Classification name:

The Imation™ SE-204 laser imager is intended use as a high resolution hard copy device for output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the SE-204 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities, including, but not limited to Digital Radiography and full view digital mammography for diagnostic use by medical radiologists and communications to referring physicians and their patients.

21 CFR 892.1000

#### Technological Characteristics:

The subject device and predicate devices use the same technical design base. The printers receive image data from the modality. Modality data and printing functions are performed by the IMS(Image management System). User control is performed by a keypad or directly by the modality through the host control. Imation imaging media is removed from a daylight cartridge and transported to the laser imaging station. Image data and media merge at the laser station and the film is scanned. The exposed media is transported through the integrated processor and exits the printer.

Software is used to control the image management and machine functions. AIQC(Automated Image Quality Control) matches printing power with film characteristics to provide consistently high image quality.

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#### Performance Data:

An important performance characteristics for medical hard copy devices is spatial resolution. The subject and the predicate Agfa devices are similar with respect to spatial resolution with SE-204 pixels giving slightly higher dpi.

Safety and effectiveness are assured via meeting voluntary standards, including IEC601-1, IEC601-1-1, IEC601-1-2, UL2601 and Imation™ SE-204 Engineering specification(Part B).

With the successful conclusion of both the field test and internal tests for qualification, validation and reliability, the Product Team will approve final release for production (including Software). After final approval, according to the established procedures, the software code label will be changed to production level label.

#### Conclusion:

The subject device, like the predicates, has no patient contact. The devices also do not control. monitor or otherwise affect any devices directly connected to or affecting the patient. Images displayed by the subject device and its predicates are reviewed by medical personnel, offering ample opportunity for competent human intervention in case of a malfunction or other failure.

The subject and predicate device DryView™ Model 8300 have both been designed to the same safety standard. As with this predicate device, a test pattern generator and automatic image quality control(AIOC) system are incorporated to assure consistency between input signals and output density. The subject device has been designed to have similar resolution as the predicate Agfa LR 5200 Laser Film Recorder, which has the indications for use of full view digital mammography and high resolution computed radiography.

Imation therefore concludes that the Imation™ SE-204 Laser Imager is as safe and effective as the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 19 1997

Steven G. Slavens Regulatory Affairs Manager Imation Enterprises Corporation 3M Center, Bldg. 235-2B-23 St. Paul, MN 551441000

Re:

K972822 Imation SE-204 Laser Imager Dated: October 18, 1997 Received: October 21, 1997 Regulatory class: Unclassified Procode: 90 LMC

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 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 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 requirement, 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 regulation 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/dsmamain.html".

Sincerely yours.

h. William Yu, Ph.D.

Lillian Yin, Ph.D. 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): ----------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: Imation™ SE-204 Laser Printer

Indications for Use:

The Imation™ SE-204 laser imager is intended use as a high resolution hard copy device for output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the SE-204 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities, including, but not limited to Digital Radiography and full view digital mammography for diagnostic use by medical radiologists and communications to referring physicians and their patients.

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align: left;">✓</div> |
| OR | Over the Counter Use ______ |
| (Division Sign-Off) | <div style="text-align: left;"><img alt="signature" src="signature.png"/></div> |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K972522 |