(88 days)
Not Found
None
No
The summary does not contain any mention of AI, ML, or related concepts, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as being used for "routine radiography and follow-up x-rays," which are diagnostic imaging procedures, not therapeutic treatments.
Yes
The device is described as being used for "routine radiography and follow-up x-rays after studies such as (e.g. gastrointestinal studies, chest, bone, arthrography, myelography, interventional, emergency, and trauma radiology)," which are procedures performed to diagnose medical conditions by visualizing internal structures of the body.
No
The summary describes a device used for routine radiography and follow-up x-rays, which inherently involves hardware (an x-ray machine). The description does not indicate that the device is solely software controlling or processing data from existing hardware.
Based on the provided information, the Symphony 200 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "routine radiography and follow-up x-rays". This describes an imaging device used to capture images of the inside of the body, not a device used to test samples (like blood, urine, or tissue) outside the body.
- Input Modality: The input modality is "x-rays", which is an imaging technique, not a method for analyzing biological samples.
- Anatomical Site: The anatomical sites mentioned (gastrointestinal, chest, bone) are areas of the body being imaged, not samples being tested.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The Symphony 200 is an imaging device used for diagnostic purposes, but it does so by capturing images, not by analyzing biological samples.
N/A
Intended Use / Indications for Use
The Symphony 9090 is intended to be used for routine radiography and follow-up x-rays after studies such as (e.g. gastrointestinal studies, chest, bone, arthrography, myelography, interventional, emergency, and trauma radiology).
Product codes
90 JAA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 1998
Jim Lambrecht Official Correspondent Progråm Director Acoma Medical Imaging Inc. 150 Chaddick Drive Wheeling, Illinois 60090
Re:
Symphony 9090 Remote Control Table Dated: March 30, 1998 Received: April 3, 1998 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA
Dear Mr. Lambrecht:
We have reviewed your Section 510%) 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 II (Scecial 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 (OS) 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 reculatory 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 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 predication 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 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/dsmaldsmamain.html".
Sincerely yours,
Kilian Yi
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Indications for use:
9090
The Symphony 200 is intended to be used for routine radiography and follow-up x-rays after studies such as (e.g. gastrointestinal studies, chest, bone, arthrography, myelography, interventional, emergency, and trauma radiology).
David A. Bergman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)