(24 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific algorithms typically associated with AI/ML in medical imaging. The description focuses on standard X-ray system components and functions.
No
The device is described as an X-ray system intended for examinations, which are diagnostic procedures, not therapeutic interventions.
Yes
The device is used for "examinations" and "evaluation," which are diagnostic activities to determine the current state of a patient's anatomy or organs. While it doesn't explicitly mention diagnosing diseases, the act of examining and evaluating anatomical regions and organs is inherently a step towards diagnosis.
No
The device description explicitly states it is a "Stationary X-ray System," which is a hardware device. It also mentions components and accessories, further indicating it is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device is an X-ray system used for imaging the inside of the human body directly.
- The intended use clearly describes imaging procedures. The description focuses on radiographic and fluoroscopic examinations of the entire human anatomy, gastrointestinal tract, and organs. This is a direct imaging modality, not a test performed on a sample.
- The device description aligns with an imaging system. It mentions components like signal analysis and display equipment, patient and equipment supports, which are typical for an X-ray machine.
In summary, this device is an in vivo diagnostic imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Routine Radiographic/Fluoroscopic examinations of the entire human anatomy, gastrointestinal tract, interventional capabilities, and organ examination.
Product codes
90 KPR
Device Description
The FV-RF is a Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various anatomical regions. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
entire human anatomy, gastrointestinal tract
Indicated Patient Age Range
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Intended User / Care Setting
health care professionals who are trained and responsible for radiographic and fluoroscopic examinations.
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
Effectiveness is established by Shimadzu's evaluation throughout all phases of the FV-RF development. The product will perform in accordance with the development specifications. The FV-RF represents the current state-of- the-art technology, therefore, is equivalent to legally marketed devices.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.
0
K9841111
Picker 510(k) Notice
FV-RF
Summary of Safety and Effectiveness
This is a summary of the information submitted by Picker International, Inc. to the Office of Device Evaluation (ODE), specifically DRAERD of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 513(f)(3).
The FV-RF is a Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various anatomical regions. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Preliminary functional specifications and operator's instructions are included in the Attachments "B" and "C" respectively. Final documentation will be provided with production units.
The FV-RF is substantially equivalent to legally marketed devices and is under control of health care professionals who are trained and responsible for radiographic and fluoroscopic examinations. The FV-RF will be certified to comply with Federal Diagnostic X-Ray Performance Standards. Labeling (Product Specification and Operator's Manual) will be provided to the user of the equipment.
Shimadzu adheres to FDA 21 CFR 820, 1020.30 through 32, and voluntary standards for safety and effectiveness (UL 187) all of which mandate that components are tested to minimize hazards (electrical, mechanical, and radiation). In addition, the system is designed to conform to IEC 601-1.
Effectiveness is established by Shimadzu's evaluation throughout all phases of the FV-RF development. The product will perform in accordance with the development specifications. The FV-RF represents the current state-of- the-art technology, therefore, is equivalent to legally marketed devices.
Shimadzu has reviewed all known information and performed an investigation as to the causes of safety and effectiveness concerning the FV-RF. In addition, all information contained in this 510(k) Notice is accurate and complete.
1
Image /page/1/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 1998
Michael J. Hayes Senior Product Review Engineer Picker International, Inc. 595 Milner Road Cleveland, Ohio 44143
Re: K984111
FV-RF (Radiographic/Fluoroscopic System) Dated: November 16, 1998 Received: November 17, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR
Dear Mr. Hayes:
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 II (Special Controls) or class III (Premarket Approvial), 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 Ouality System Regulation (OS) for Medical Devices: General regulation (2) 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 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 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/dsmardsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
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
2
page 1 of 1 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FV-RF Number (if known): K_
Device Name: FV-RF
Indications for Use: Routine Radiographic/Fluoroscopic examinations of the entire human anatomy, gastrointestinal tract, interventional capabilities, and organ examination.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological I 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)