(49 days)
The digital radiography unit DAR-7000 is a radiography The digital faulography director using the flat panel sensor as X-ray detector. X-ray detector equipped wi':ht sensor as X-ray detector. I ollous user to acquire a high sensor as X-ray detector) allows user to acquire a hiujh-Detector) arrows ason to display divisioing quality image. quality image. Inis system is accuribulate that image dita. This unit is not used for mammography.
The digital radiography unit DAR-7000 is a radiography The digital faulography director using the flat panel sensor as X-ray detector. X-ray detector equipped wi':ht sensor as X-ray detector. I ollous user to acquire a high sensor as X-ray detector) allows user to acquire a hiujh-Detector) arrows ason to display divisioing quality image. quality image. Inis system is accuribulate that image dita. This unit is not used for mammography.
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the DAR7000 RADspeed SAFIRE device. It does not contain any information about the acceptance criteria, device performance, study design, sample sizes, ground truth establishment, or expert qualifications that you requested.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given text.
The document primarily focuses on the regulatory status of the device, confirming its substantial equivalence to predicate devices and outlining the applicable regulations. It does not delve into technical performance details or the results of any clinical studies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Shimadzu Corporation % Mr. Randal Walker Director, National Service Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328
AUG 23 2013
Re: K050925
Trade/Device Name: DAR7000 RADspeed SAFIRE Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: April 6, 2005 Received: April 14, 2005
Dear Mr. Walker:
This letter corrects our substantially equivalent letter of June 1, 2005.
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 comply with all the Act's requirements, 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 practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office 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 Division of Small 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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Page 1 of 1
| 510(k) Number (if known): | K050925 |
|---|---|
| Device Name: | DAR7000 RADspeed, SAFIRE |
Indications For Usc:
The digital radiography unit DAR-7000 is a radiography The digital faulography director using the flat panel sensor as X-ray detector. X-ray detector equipped wi':ht
sensor as X-ray detector. I ollous user to acquire a high sensor as X-ray detector) allows user to acquire a hiujh-Detector) arrows ason to display divisioing quality image. quality image. Inis system is accuribulate that image dita. This unit is not used for mammography.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Over-The-Counter Use OR Prescription Usc XXXXXX (Optional Forms( 1-2-96) (Pcr 21 CFR 801.109) (Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODIE)
§ 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.