(34 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, and the device description is not available to infer such capabilities.
No
The device is described as being used for radiography with X-ray devices in a hospital setting for diagnostic purposes, not for treating diseases or conditions.
No
Explanation: The device is described as being used for "radiography" and its object is the "total patient population." It is intended for use in the hospital with X-ray devices. This implies it is a device used to produce images (X-rays) rather than to interpret or diagnose from them. Diagnostic devices typically process or analyze data to provide information for diagnosis, which is not indicated here.
Unknown
The provided text does not contain a device description, which is crucial for determining if the device is software-only. The intended use mentions "radiography in the hospital with X-ray devices," implying interaction with hardware, but it doesn't explicitly state whether the device itself is hardware, software, or a combination.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "radiography in the hospital with X-ray devices." This describes a device used for medical imaging on a patient, not for testing samples from a patient in a lab setting.
- Input Imaging Modality: The input is "X-ray," which is an imaging technique applied to the body, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information about a patient's health status based on laboratory tests.
The device appears to be a component or system used in conjunction with X-ray equipment for diagnostic imaging.
N/A
Intended Use / Indications for Use
/ This device is intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population. As mentioned at "Intended Use" in this clearance letter, the intended use of DAR-8000f is the same as that of predicate device of DAR-7000(K050925). Consequently, the indications for use of DAR-8000f are also the same as that of DAR-7000, and there are no additional indications.
Product codes
IZI
Device Description
Not Found
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
total patient population
Intended User / Care Setting
physicians and X-ray technologist / hospital
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)
DAR-7000(K050925)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with three curved lines extending from its head, resembling feathers or wings.
Public Health Service
OCT 17 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Randal Walker Director, National Service Shimadzu 20101 South Vermont Ave. TORRANCE CA 90502-1328 Re: K052500 Trade/Device Name: DAR-8000f Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: September 9, 2005 Received: September 14, 2005
Dear Mr. Walker:
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 either class II (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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 premated 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), please 11 70a debtro of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR | ||
|---|---|---|
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 00 : 7 ). " Canal Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Notification Submission, DAR-8000f
Page 31
SECTION XIII: INDICATION FOR USE
510(k) Number(if known): Unknown K052500
Device Name: DAR-8000f
Indication for use :
/ This device is intended to be used for the radiography in the hospital with X-ray devices.
This device is operated and used by the physicians and X-ray technologist. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
/ The object of this device is total patient population.
As mentioned at "Intended Use" in this clearance letter, the intended use of DAR-8000f is the same as that of predicate device of DAR-7000(K050925).
Consequently, the indications for use of DAR-8000f are also the same as that of DAR-7000, and there are no additional indications.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON THE ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
| Prescription Use |
|---|
| (Per21 CFR801.109) |
OR
Over-The-Counter Use
Nancy C. Bridgdon
(Division Sign Division of Reproductive and Radiological Devic 510(k) Number