(52 days)
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Not Found
No
The summary does not mention AI, ML, deep learning, or any related concepts, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as an "angiographic X-ray system" used for "radiologic visualization" and "diagnosis of the circulatory vascular system," which are diagnostic rather than therapeutic functions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "It is to be used in the diagnosis of the circulatory vascular system while being combined with a positin ing device and other devices."
No
The device is described as an "angiographic X-ray system," which is a hardware-based medical device used for imaging. The description aligns with the definition of an X-ray system, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to examine specimens outside of the body.
- Device Description: This device is an angiographic X-ray system. X-ray systems are imaging devices that work by passing radiation through the body to create images.
- Intended Use: The intended use is for "radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium." This is a diagnostic procedure performed on the patient's body, not on a sample taken from the body.
Therefore, based on the provided information, this device clearly falls under the category of an imaging device used for in-vivo diagnosis, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is an angiographic X-ray system, as described in 21 CFR 892.1600. This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positin ing device and other devices.
Product codes
IZI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
heart, blood vessels or lymphatic system (circulatory vascular system)
Indicated Patient Age Range
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Intended User / Care Setting
Physicians and X-ray Technologists
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT - 5 2006
Mr. Randall Walker Director. North American Service Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328
Re: K062360
Trade/Device Name: BRANSIST Safire Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class II Product Code: IZI Dated: July 31, 2006 Received: August 15, 2006
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.
Image /page/0/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, "PA" in the center, and "Centennial" at the bottom. There are three dots below the word "Centennial". The logo appears to be a commemorative emblem, possibly for an organization's 100th anniversary.
Protecting and Promoting Public Health
1
Page 2 -
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.
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 10gally 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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistances at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address littp://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
BRANSIST Safire
Section XIII: INDICATION FOR USE
510(k) Number: Unknown K062360
Device name: BRANSIST Safire
Indication for use:
This device is an angiographic X-ray system, as described in 21 CFR 892.1600. This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positin ing device and other devices.
This device is operated and used by physicians and X-ray Technologists.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Lynam
sion of Reproduct and Radiological Devi 510(k) Numbe
Prescription Use_