(81 days)
No
The document describes a medical imaging monitor, which is a display device. There is no mention of any analytical or processing capabilities that would suggest the use of AI or ML. The device's function is solely to display images for human interpretation.
No.
The device is a medical imaging monitor used for diagnostic purposes by displaying x-ray images; it does not directly treat or restore health.
Yes
The device's description explicitly states that it is a "diagnostic display" and is "used by trained medical providers for the purpose of diagnosing... illnesses."
No
The device is described as a "Medical Imaging Monitor" and a "high resolution monitor with the electronic capability necessary for displaying high resolution medical images," indicating it is a hardware device.
Based on the provided information, the Data Ray Corporation DR11021 Medical Imaging Monitor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this monitor is used to display digitized x-ray images. X-ray images are generated from the human body, but they are not a specimen from the body in the way that blood, urine, or tissue samples are.
- The device's function is display, not analysis of biological samples. The monitor's purpose is to present visual information (the x-ray images) to a trained medical professional for their analysis and diagnosis. It does not perform any tests or analysis on biological materials.
The device is a medical imaging display, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Data Ray Corporation DR11021 Medical Imaging Monitor is intended to be used by radiologists/trained practitioners to examine digitized x-ray images for the purpose of medical analysis.
The Data Ray Corporation DR11021 Medical Imaging Monitor is used in filmless radiology systems to display digitized x-ray images. These digitized x-ray images are viewed by trained medical providers for the purpose of diagnosing and/or treating illnesses in human beings.
Product codes
90 LMD, 90 LLZ
Device Description
The DR11021 Medical Imaging Monitor is a diagnostic display used in film-less radiology applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists/trained practitioners, trained medical providers
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)
Barco NV/Display Systems, Barco MGD 521 5 Megapixel Diagnostic Display (K980541)
Reference Device(s)
Barco MWD 321 Medical Workstation Display (K972701), Sony Medical Systems Division, Sony PGM-1001MD Trinitron Color Graphic Monitor (K970999), Aurora Technology, Aurora Diagnostic Workstation (K962589), Accuimage Inc., Accuimage Inc. Image Display Processor (K961023), GE Medical Systems, GE Advantage Windows Review Workstation (K960613)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(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).
0
Image /page/0/Picture/0 description: The image shows the logo for DATA-RAY Corporation. The logo is in black and white, with the words "DATA-RAY" in large, bold letters. Below the words "DATA-RAY" is a horizontal line, and below that is the word "CORPORATION" in smaller letters. The logo is simple and clean, and it is likely used to identify the company.
DEC 15
12300 Pecos Street Westminster, CO 80234 Phone: 303-451-1300
K98392
510(k) Notification
PREMARKET NOTIFICATION SUMMARY
Manufacturer: Data Ray Corporation 12300 Pecos Street Westminster, CO 80234
Greg Roberts, Compliance Engineer Contact Information: Phone: 303-451-1300 Fax: 303-451-1143
Classification Name: Display, cathode ray tube, image communication accessory/device
Common Name: Monitor, monochrome monitor, display, high-resolution monitor, and the like.
Manufacturer's Name: DR11021 Medical Imaging Monitor
Classification Number: 90 LMD
Substantially Equivilant To: Barco NV/Display Systems, Barco MGD 521 5 Megapixel Diagnostic Display (K980541), Barco MWD 321 Medical Workstation Display (K972701), Sony Medical Systems Division, Sony PGM-1001MD Trinitron Color Graphic Monitor (K970999), Aurora Technology, Aurora Diagnostic Workstation (K962589), Accuimage Inc., Accuimage Inc. Image Display Processor (K961023), GE Medical Systems, GE Advantage Windows Review Workstation (K960613), and others.
Device Description: The DR11021 Medical Imaging Monitor is a diagnostic display used in film-less radiology applications.
Intended Use: The Data Ray Corporation's DR11021 Medical Imaging Monitor is intended to be used by radiologists/trained practitioners to examine digitized x-ray images for the purpose of medical analysis.
Technological Characteristics: The Data Ray Corporation DR11021 Medical Imaging Monitor is a high resolution monitor with the electronic capability necessary for displaying high resolution medical images for the purpose of evaluation.
1
Re:
Image /page/1/Picture/1 description: The image shows a partial logo on the left and the word "DE" on the right. The logo appears to be a stylized eagle or bird with three lines representing its wings or feathers. The word "DE" is in a bold, sans-serif font and is positioned to the right of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 15 1998
Greg Roberts Compliance Engineer Data-Ray Corporation 12300 Pecos Street Westiminster, CO 80234
K983392 DR11021 Medical Imaging Monitor Dated: September 18, 1998 Received: September 25, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Roberts:
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 III (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 requlation (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 require in requlatory 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 obliation 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 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 (301) 594-4613. 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 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 (800) 638-2041 or (301) 443-6597, 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
2
Page _ of _
210(k) NUMBER(IF KNOWN): K9883392 K イタ アスタイ
DEVICE NAME: DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR
INDICATIONS FOR USE :
The Data Ray Corporation DR11021 Medical Imaging Monitor is used in filmless radiology systems to display digitized x-ray images. These digitized x-ray images are viewed by trained medical providers for the purpose of diagnosing and/or treating illnesses in human beings.
DO NOT WRITE BELOW THIS LINE
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
Daniel A. Segen
(Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological Devices 510(k) Number