(88 days)
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Not Found
No
The document describes a laser imager for creating hard copies of medical images. While it mentions "AIQC (Automatic Image Quality Control)", this is likely a form of automated calibration or feedback control, not necessarily AI/ML in the sense of learning from data to perform complex tasks or make predictions. There is no mention of training or test data, which are typical indicators of AI/ML development.
No
The device is described as an imager for creating hard copies of medical images for diagnosis and referral, not for therapeutic purposes.
No
The device is a hard copy output device (laser imager) that produces film from digital imaging sources. It is used for medical imaging diagnosis and referral, but it does not perform diagnosis itself.
No
The device is a laser imager that transforms electronic signals optically to expose imaging media, indicating it is a hardware device with integrated software for image processing and control.
Based on the provided text, the Imation™ SE-196 laser imager is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Imation SE-196 is a hard copy device that creates film output from digital medical images (CT, MR, CR). It processes electronic image signals and exposes imaging media.
- Intended Use: Its intended use is for creating hard copies of medical images for diagnosis and referral by medical radiologists and referring physicians. It does not analyze biological specimens.
The device is clearly focused on the output and display of medical images generated by other modalities, not on the analysis of biological samples.
N/A
Intended Use / Indications for Use
The Imation™ SE-196 laser imager is intended use as a high quality 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-196 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities including CT, MR and CR for diagnostic use by medical radiologists and communications to referring physicians and their patients.
Product codes
90 LMC
Device Description
The Imation SE-196 Laser Imager provides high quality hard copy film output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the SE-196 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities including CT, MR and CR for diagnostic use by medical radiologists and communications to referring physicians and their patients.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT, MR and CR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical radiologists and referring physicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Important performance characteristics for medical hard copy devices are spatial frequency response, gray scale resolution and density information. The subject and predicate devices are similar with respect to spatial frequency response with pixel size of both devices being 325 dpi. Gray scale resolution for the predicate is wither 8 or 12 bit and 12 bit only for the subject device. Density uniformity of the subject device is the same or better than the predicate devices have built in density test patterns and AIQC (Automatic Image Quality Control) that maintains density uniformity over time and over changes in the film media.
Key Metrics
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Predicate Device(s)
3M(Imation™) 8700 Laser Imager
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.2040 Medical image hardcopy device.
(a)
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.(b)
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.
0
510(k) Summary
K972163 SEP - 5 1997
June 1, 1997
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 FAX: 612-736-3116
| Device: | |
|---|---|
| Trade name: | Imation TM SE-196 Laser Imager |
| Common name: | Laser Printer |
| Classification name: | Magnetic Resonance Diagnostic Device |
| 21 CFR 892.1000 |
3M(Imation™) 8700 Laser Imager Predicate devices:
Description And Intended Use of Device:
The Imation SE-196 Laser Imager provides high quality hard copy film output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the SE-196 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities including CT, MR and CR for diagnostic use by medical radiologists and communications to referring physicians and their patients.
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.
Performance Data:
Important performance characteristics for medical hard copy devices are spatial frequency response, gray scale resolution and density information. The subject and predicate devices are similar with respect to spatial frequency response with pixel size of both devices being 325 dpi. Gray scale resolution for the predicate is wither 8 or 12
1
bit and 12 bit only for the subject device. Density uniformity of the subject device is the same or better than the predicate devices have built in density test patterns and AIQC (Automatic Image Quality Control) that maintains density uniformity over time and over changes in the film media.
Safety and effectiveness are key activities in the commercialization and are assured via meeting voluntary standards, including UL544, IEC601-1, IEC 825 and Imation™ SE-196 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 effect any devices directly connected to or effecting 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.
Films imaged by the subject device display the same or better image properties in the areas of spatial and gray-scale resolution and in density uniformity as the predicate. As with the predicate devices, a test pattern generator and automatic image quality control(AIQC) system are incorporated to assure consistency between input signals and output density.
The subject and predicate device(s) have all been designed to the same safety standard, UL1950.
Imation therefore concludes that the Imation™ SE-196 Laser Imager is as safe and effective as the predicate device
2
Image /page/2/Picture/0 description: The image shows a black and white logo for the Department of Health. The logo features a stylized bird-like symbol with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH" are arranged vertically along the left side of the symbol, with the letters oriented to be read from top to bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stephen G. Slavens Regulatory Affairs Imation Corp. 1 Imation Place Oakdale, MN 55128-3414 SEP - 5 1997
Re: K972163
Imation™ SE-196 Laser Imager Dated: June 1, 1997 Received: June 9, 1997 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 submission 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 yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
htliau Yin
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
3
ATTACHMENT 2
Statement of Indications for Use:
510(K) Number (if known): K972163
Device Name: Imation™ SE-196 Laser Printer
Indications for Use:
The Imation™ SE-196 laser imager is intended use as a high quality 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-196 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities including CT, MR and CR for diagnostic use by medical radiologists and communications to referring physicians and their patients.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Perscription Use × (Per 21 CFR 801.109)
OR
Over the Counter Use
Vorris C. klairr
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number