(13 days)
This device is intended to be used for generating fluoroscopic images of human anatomy for the diagnostic, surgical and interventional angiography and cardiology procedures of circulatory vascular system.
Not Found
The provided documents are a 510(k) submission and the FDA's acknowledgement letter for the Shimadzu GE OEC Altitude Angiographic X-ray System. These documents confirm the device's classification, intended use, and substantial equivalence to a predicate device.
However, the provided text does not contain any information regarding specific acceptance criteria, device performance metrics, study designs (sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to an AI/ML-based device.
The GE OEC Altitude is an Angiographic X-ray System, a hardware medical device used for generating fluoroscopic images. The 510(k) refers to its physical components (MH-100 and DAR-2400-15B/30B from the predicate device Shimadzu Angiosigma NEO) and its functionality as an imaging system, not an AI/ML diagnostic or assistive tool.
Therefore, I cannot provide the requested information because the provided input does not describe an AI/ML-based device or a study proving its performance against acceptance criteria in the context of AI/ML. The 510(k) process for this type of device typically focuses on technical specifications, safety, and performance characteristics like radiation dose, image quality (spatial resolution, contrast), and mechanical integrity, rather than diagnostic accuracy metrics produced by an AI.
{0}------------------------------------------------
207,717
Medical Systems Division,
Quality Assurance Department
1,Nishinokyo-Kuwabaracho.Nakagyo-ku,Kyoto 604-8511, Japan Phone: +81-75-823-1307 Fax: +81-75-823-1377
January 31, 2007
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
JUL - 5 2007
Re: Abbreviated Premarket Notification 510(k) Submission
To Whom It May Concern:
In accordance with section 510(k) of the Federal Food, Drug and Cosmetic Act, Shimadzu Corporation is hereby submitting this Premarket notification prior to marketing the GE OEC Altitude SYSTEM in the United States.
| DEVICE CLASSIFICATION:CLASSIFICATION PANEL:CLASSIFICATION NAME(S):PRODUCT CODE:COMMON NAME:PROPRIETARY NAME:PREDICATE DEVICE: | Class II by CFR 892.1600RadiologyAngiographic X-ray System90IZIGE OEC AltitudeShimadzu CorporationShimadzu Angiosigma NEO which consists ofMH-100 (K943545) and DAR-2400-15B/30B(K955395). |
|---|---|
| The Official Contact is: | Mr. Akira ShigeyasuManager, Quality Assurance DepartmentMedical Systems DivisionShimadzu Corporation1, Nishinokyo-KuwabarachoNakagyo-ku, Kyoto 604-8511, JapanPhone: +81-75-823-1307 / Fax: +81-75-823-1377e-mail: sigeyasu@shimadzu.co.jp |
| The owner is located at: | Shimadzu Corporation1, Nishinokyo-Kuwabaracho, Nakagyo-kuKyoto 604-8511, Japan |
The manufacturing facility:
Shimadzu Corporation
Please direct any additional questions or requests for information to our official contact.
Respectfully,
{1}------------------------------------------------
510(K) Notification Submission, GE OEC Altitude
Abbreviated 510K
Date: Our Reference:
Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, Maryland 20850
Re: Abbreviated 510(k) Notification Angiographic X-ray System GE OEC Altitude
Dear Sir or Madam:
This submission is being made in compliance with Section 510(k) of the Food, Drug and Cosmetic Act as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990 and the Food, Drug administration Modernization Act of 1997, and the Office of Device Evaluation guidance for Abbreviated 510(K) requirement far Digital Radiography System. The enclosed information is being submitted for our Angiographic X-ray System, GE OEC Altitude. Two copies of this Premarket Notification are being submitted in accordance with 21 CFR 807.
The purpose of this submission is to notify FDA , in accordance with the 510(K) provisions of the Act, of our intent to introduce this modified device.
A Table of Contents for the submission is located immediately following this letter. Should you have any questions or require additional information, please feel free to contact:
Thank you for your attention to this matter. Sincerely yours.
Akira Shizeyasan
Akira Shigeyasu Manager, Quality Assurance Medical Systems Division Shimadzu Corporation Kyoto Japan
Technical Responsibilities: cc. O.Sasaki
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is a stylized graphic consisting of three curved lines that resemble a person's profile. The lines are stacked on top of each other, with the bottom line having a wavy end.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL - 5 2007
Shimadzu Corporation % Mr. Tamas Borsai Division Manager, Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K071717
Trade/Device Name: GE OEC Altitude Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: June 20, 2007 Received: June 22, 2007
Dear Mr. Borsai:
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/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line beneath the word "Centennial".
Protesting and Promoting Public Health
{3}------------------------------------------------
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 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 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 Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/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
{4}------------------------------------------------
INDICATIONS FOR USE SECTION XIII:
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: GE OEC Altitude
Indications for use:
/ This device is intended to be used for generating fluoroscopic images of human anatomy for the diagnostic, surgical and interventional angiography and cardiology procedures of circulatory vascular system.
/ This device is operated and used by the physicians, X-ray technologist and radiologists.
/ This device can be used in conjunction with a mobile or fixed surgical table.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Reproductive. Abdominal a Radiological Devices 510(k) Number
Page 1 of
§ 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.