(196 days)
DAR-2400-15B/30B (K955395)
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML, and the device description and performance study sections are not available.
No.
The device is used in angiography with X-ray devices, implying it is for diagnostic imaging rather than therapy. Its intended use is the same as its predicate device (K955395), which is a digital angiography system. These systems are used for visualization, not treatment.
No
The provided text describes the device's intended use in angiography with X-ray devices and mentions its operation by physicians and X-ray technologists. It does not state that the device is used to diagnose diseases or conditions, nor does it refer to diagnostic capabilities like detection, identification, or quantitative measurement for clinical interpretation.
Unknown
The provided text does not contain a device description, which is crucial for determining if the device is software-only. It mentions use with X-ray devices, which are hardware, but doesn't clarify if the submitted device is solely the software component interacting with that hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used in Angiography in Hospital with X-ray devices. This describes a procedure performed on a patient using imaging technology, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- Mentions image processing, AI, DNN, or ML (Not Found): These are not directly relevant to whether a device is an IVD.
- Input Imaging Modality (X-ray): X-ray is an imaging modality used on the patient, not for analyzing samples in vitro.
- Anatomical Site (Not Found): While not found, the intended use points to a procedure on the patient.
- Indicated Patient Age Range (total patient populations): This refers to the patient population, not the type of sample being tested.
- Intended User / Care Setting (Physicians and X-ray technologist / Hospital): This describes the users and location of use, which are consistent with a medical device used in a hospital setting for patient procedures.
- Description of training/test sets, performance studies, key metrics (Not Found): These are often associated with devices that perform analysis or provide diagnostic information, but their absence doesn't automatically make it an IVD.
- Predicate Device(s): The predicate device is also likely a similar type of device used in angiography, further supporting that this is not an IVD.
In summary, the core function described is related to medical imaging and procedures performed on a patient, which is the defining characteristic of a medical device used in vivo, not an IVD.
N/A
Intended Use / Indications for Use
- This device is intended to be used in the Angiography in Hospital with the X-ray devices.
- This device is operated and used by Physicians and X-ray technologist.
- The object of this device is total patient populations.
Product codes (comma separated list FDA assigned to the subject device)
90 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 populations.
Intended User / Care Setting
Physicians and X-ray technologist. / Angiography in 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
DAR-2400-15B/30B (K955395)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2004
Mr. Takeshi Ozaki Director, National Service Shimadzu Medical Systems 20101 South Vermont Ave. TORRANCE CA 90502-1328 Re: K032443 Trade/Device Name: DAR-5000 Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: 90 IZI Dated: December 17, 2004 Received: December 24, 2004
Dear Mr. Ozaki:
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 (PMA), 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 (OS) 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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
11032443 Notification Submission, DAR-5000 510(K)
Page 18
| SECTION XIII: | INDICATION FOR USE |
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| A | |
| Company of Concession Comments of Children Comments of | |
| and the a more of the are a may be a free |
Page1 of1
510(K) Number(if known) : ____________________________________________________________________________________________________________________________________________________ Unknown
DAR-5000 Device Name:
Indications For Use :
- / This device is intended to be used in the Angiography in Hospital with the X-ray devices.
- This device is operated and used by Physicians and X-ray technologist. 1
- / The object of this device is total patient populations.
As mentioned at "Intended Use" in this clearance letter, the intended use of the DAR-5000 is the same as that of predicate device DAR-2400-15B/30B (K955395).
Consequently, the indications for use of the DAR-5000 are also the same as that of the DAR-2400-15B/30B (K955395), and there are no additional indications.
(Please DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use (Per21CFR801.109)
OR Over-The-Counter Use
David R. Legum
and the submit and the submit of the submit of the subsequence of
and Radiological Devic 510/k) Numb