(79 days)
Not Found
No
The document describes standard image processing for printing medical images and does not mention AI, ML, or related concepts.
No.
The device is used for printing diagnostic images on film, aiding in physician diagnosis, rather than directly treating a condition.
No
The device is an image recording device (printer) that produces diagnostic quality medical images on film for physician diagnosis. It aids in diagnosis by presenting images but does not perform the diagnosis itself.
No
The device description clearly states it is an "image recording device" that uses "laser exposure and thermal development to print on medical dry imaging films," indicating it is a hardware device with physical components and processes.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "providing diagnostic quality medical images on film for aid in physician diagnosis" by printing images from various medical imaging modalities (CT, MRI, Ultrasound, etc.). This involves processing and outputting images of the human body, not analyzing biological samples or specimens.
- Device Description: The description confirms it's an "image recording device" that prints digital image data onto film. It doesn't mention any interaction with biological materials or the analysis of samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information about a patient's health status based on sample analysis
The device is a medical imaging output device, designed to produce physical copies of images generated by other diagnostic imaging equipment. It does not perform any diagnostic testing on biological samples, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
Fuji Medical Dry Laser Imagers, models DRYPIX 7000, DRYPIX 5000 and FM-DP L are indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis, including the printing of images and associated identification information from various digital imaging source modalities, including but not limited to, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Radiography, Digital Mammography and Nuclear Medicine.
Product codes
90 LMC
Device Description
Fuji Medical Dry Laser Imagers models DRYPIX 7000, DRYPIX 5000 and FM-DP L are image recording devices that use laser exposure and thermal development to print on medical dry imaging films the digital image data that is sent from medical diagnostic imaging modalities. Image processing is performed on the obtained digital images, and via laser exposure, and thermal development the le perfermou on tilm. The main difference between the FM-DP L device and the DRYPIX devices are image throughput. The only difference in the DRYPIX devices is that the DRYPIX 7000 is a 220 Vac version while the DRYPIX 5000 is a 110 Vac version.
Mentions image processing
Image processing is performed on the obtained digital images
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Radiography, Digital Mammography and Nuclear Medicine.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the Fujifilm logo. The logo consists of the Fujifilm symbol on the left and the word "FUJIFILM" in bold, black letters on the right. Below the word "FUJIFILM" is the text "I&I-Imaging & Information".
K033377
Page 1 of 2
FUJIFILM MEDICAL SYSTEM
419 WEST AVENUE STAMFORD, CT 06902 Telephone: 203/324-2000 Fax: 203/353-0926
510(K) Summary
in accordance with the requirements of the Safe Medical Device Act, FUJIFILM Medical Systems, USA, Inc. herewith submits a 510(K) summary of safety and effectiveness for the following device.
| SUBMITTER NAME / ADDRESS: | FUJIFILM Medical Systems, USA, Inc.
419 West Avenue
Stamford, CT 06902 |
|---------------------------|------------------------------------------------------------------------------|
| CONTACT PERSON / TEL NO: | Frank Gianelli
Regulatory Coordinator
Tel No: (203) 602-3774 |
| DATE SUMMARY PREPARED: | October 17, 2003 |
| ESTABLISHMENT NO.: | 2443168 |
| TRADE/PROPRIETARY NAME: | Fuji Medical Dry Laser Imagers, models
DRYPIX 7000, DRYPIX 5000, FM-DP L |
| COMMON/USUAL NAME: | Medical Dry Laser Imager |
| CLASSIFICATION NAME: | Medical Image Hardcopy Device |
| CLASS/PANEL: | Class II, 90-LMC, 21CFR 892.2040 |
DEVICE DESCRIPTION:
Fuji Medical Dry Laser Imagers models DRYPIX 7000, DRYPIX 5000 and FM-DP L are image recording devices that use laser exposure and thermal development to print on medical dry imaging films the digital image data that is sent from medical diagnostic imaging modalities. Image processing is performed on the obtained digital images, and via laser exposure, and thermal development the le perfermou on tilm. The main difference between the FM-DP L device and the DRYPIX devices are image throughput. The only difference in the DRYPIX devices is that the DRYPIX 7000 is a 220 Vac version while the DRYPIX 5000 is a 110 Vac version.
INTENDED USE:
Fuji Medical Dry Laser Imagers, models DRYPIX 7000, DRYPIX 5000 and FM-DP L are indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis, including the printing of images and associated identification information from various digital imaging source modalities, including but not limited to, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Radiography, Digital Mammography and Nuclear Medicine.
1
Image /page/1/Picture/0 description: The image shows a handwritten note with the identifier "K033377" at the top. Below the identifier, the text "page 2 of 2" is written, indicating that this is the second page of a two-page document. The handwriting appears to be somewhat cursive and slightly messy.
Image /page/1/Picture/1 description: The image shows the Fujifilm logo. The logo consists of the word "FUJIFILM" in bold, black letters, with a smaller symbol to the left. Below the main logo, the text "I&I-Imaging & Information" is printed in a smaller, lighter font, indicating the company's focus on imaging and information technologies.
FUJIFILM MEDICAL SYSTEMS US
419 WEST AVENUE STAMFORD, CT 06902 Telephone: 203/324-2000 Fax: 203/353-0926
PREDICATE DEVICE AND SUBSTANTIAL EQUIVALENCE INFORMATION:
Fuji Medical Dry Laser Imagers models DRYPIX 7000, DRYPIX 5000 and FM-DP L are considered comparable and substantially equivalent to the Agfa LR 5200 Laser Film Recorder (K012010) manufactured by Agfa Corporation and the Kodak DRYVIEW 8610 Laser Imager (K002146) manufactured by the Eastman Kodak Company.
SAFETY INFORMATION:
Fuji Medical Dry Laser Imagers, models DRYPIX 7000, DRYPIX 5000 and FM-DP L introduce no new safety and efficacy issues other than those already identified with the predicate devices. The results of a hazard analysis, combined with the appropriate preventive measures taken indicate that the device is of minor level of concern as per the May 29, 1998 issue of the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Fuji Medical Dry Laser Imagers, models DRYPIX 7000, DRYPIX 5000 and FM-DP L comply with the following mandatory and voluntary standards:
- 21 CFR 1040.10 Performance Standards for Light Emitting Products (Laser Products) .
- . Medical Electrical Equipment Part 1: General Requirements for Safety UL Standard 60601-1 (IEC 60601-1-1 included)
- Medical Electrical Equipment Part 1: General Requirements for Safety; Electromagnetic . Compatibility - Requirements and Tests: IEC 60601-1-2
- DICOM (Digital Imaging and Communications in Medicine) Developed by the American . College of Radiology and the National Electrical Manufacturers Association.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'JAN - 9 2004
Mr. Frank Gianelli Regulatory Coordinator FUJIFILM Medical Systems, USA, Inc. 419 West Avenue STAMFORD CT 06902
Re: K033377
Trade/Device Name: Fuji Medical Dry Laser Imagers Models; DRYPIX 7000, DRYPIX 5000, and FM-DP L Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: 90 LMC Dated: October 20, 2003 Received: October 22, 2003
Dear Mr. Gianelli:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
510(k) Number (if known): _
Fuji Medical Dry Laser Imagers, models DRYPIX 7000, DRYPIX Device Name : 5000 and FM-DP L
Indications For Use :
Fuji Medical Dry Laser Imagers, models DRYPIX 7000, DRYPIX 5000 and FM-DP L are indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis, including the printing of images and associated identification information from various digital imaging source modalities, including but not limited to, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Radiography, Digital Mammography and Nuclear Medicine.
(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ( Per 21 CFR 801.109
OR
Over-The-Counter Use
Nancy C. Brogdon
(Division Sign-Off)
(Optional Format 1-2-96)
Radiological Devices
510(k) Number K033377
Division of Reproductive, Abdominal.
Page A3-2