(15 days)
The Digital Radiography System, Model DFP-8000D is a Digital Radiography Processor used in diagnostic X-ray angiography systems. This system processes, displays, and records digital images obtained from the detectors of X-ray TV systems (such as CCD cameras), and replays the recorded images for image diagnosis. This system is intended for use in diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels, and lower limb blood vessels.
The Digital Radiography System, Model DFP-8000D is a Digital Radiography Processor used in diagnostic X-ray angiography systems. This system processes, displays, and records digital images obtained from the detectors of X-ray TV systems (such as CCD cameras), and replays the recorded images.
The provided text is a 510(k) summary for the Toshiba Digital Radiography System, Model DFP-8000D. It describes the device, its intended use, and its technological characteristics in comparison to a predicate device.
However, the provided document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes for training or testing, ground truth establishment, expert qualifications, or adjudication methods.
The document is a regulatory submission summary that indicates the device received substantial equivalence to a predicate device, which allows it to be marketed. This type of submission typically focuses on demonstrating similarity to an already cleared device, rather than providing detailed performance studies with acceptance criteria as one would find for a novel device or a device requiring clinical trials.
Therefore, I cannot fulfill your request for the information outlined in your prompt based on the provided text. The prompt asks for specific details about a study and acceptance criteria that are not present in this regulatory summary.
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510(k) Summary
| NOV 1 5 2001 | ||
|---|---|---|
| Date: | September 20, 2001 | K013608 |
| Submitter's Name: | Toshiba America Medical Systems, Inc. | |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,Tustin, CA 92781-2068 | |
| Submitter's Contact: | Diana Thorson, Senior Regulatory Affairs Specialist,(714) 730-5000, Extension 4121 | |
| Device Proprietary Name: | Digital Radiography System, Model DFP-8000D | |
| Classification Name: | Image Intensified Fluoroscopic X-Ray System (Accessory) | |
| Common Name: | Image Processor[Fed. Reg. No. 892.1650, Product Code: JAA] | |
| Predicate Device: | Toshiba DFP-2000A/A4 (K941611) |
Description of this Device:
The Digital Radiography System, Model DFP-8000D is a Digital Radiography Processor used in diagnostic X-ray angiography systems. This system processes, displays, and records digital images obtained from the detectors of X-ray TV systems (such as CCD cameras), and replays the recorded images.
Summary of Intended Uses:
The Digital Radiography System, Model DFP-8000D is a Digital Radiography Processor used in diagnostic X-ray angiography systems. This system processes, displays, and records digital images obtained from the detectors of X-ray TV systems (such as CCD cameras), and replays the recorded images for image diagnosis. This system is intended for use in diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels, and lower limb blood vessels. This device employs no intended uses that are not in cleared devices already found in the marketplace.
Technological Characteristics:
The technological characteristics of this device are the similar to that of the predicate device. The differences in technological characteristics are due to the employment of updated technologies such as updated image processing, image memory, operating system, and CPU.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
MAY - 7 2012
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Toshiba America Medical Systems, Inc. % Mr. Mark Job TUV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIFHTON MN 55112-1891
Re: K013608
Trade/Device Name: Digital Radiography System; Model DFP-8000D Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: October 30, 2001 Received: October 31, 2001
Dear Mr. Job:
This letter corrects our substantially equivalent letter of November 15, 2001.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or any I caeral statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing pactice medical device-related advorse ovelits) (2) regulation (21 CFR Part 820). This letter requirences as set form in the quality of encess in your Section 510(k) premarket wification. 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 Parts 801 and If you desire specific acrise of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou may of amall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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NOV 1 5 2001
K013608 510 (k) Number (lf Known):
Toshiba Digital Radiography System, Model DFP-8000D Device Name:
Indications For Use:
The Digital Radiography System, Model DFP-8000D is a Digital Radiography Processor used in diagnostic X-ray angiography systems. This system processes, displays, and records digital images obtained from the detectors of X-ray TV systems (such as CCD cameras), and replays the recorded images for image diagnosis. This system is intended for use in diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels, and lower limb blood vessels.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and
Radiological Devices
510 (k) Number: K013608
§ 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.