(68 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any performance metrics typically associated with AI/ML algorithms. It describes a standard portable X-ray system.
No
The device description indicates it is an X-Ray system for "Portable Radiographic Applications," which are diagnostic imaging procedures, not therapeutic treatments.
No
An X-Ray system is an imaging device used to acquire images, not analyze them for diagnostic purposes. Its intended use is for "General Purpose Portable Radiographic Applications," which refers to image acquisition, not diagnosis.
No
The device is described as a "Portable X-Ray System," which inherently implies the presence of hardware components for generating and capturing X-rays. The summary does not mention any software-only functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "General Purpose Portable Radiographic Applications." This describes a device used to create images of the inside of the body using X-rays, which is an in vivo (within the living body) diagnostic method, not in vitro (outside the living body, typically involving samples like blood or tissue).
- Input Imaging Modality: The input modality is "X-Ray." X-rays are used to image the body directly, not to analyze samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on specimens, or any other activities typically associated with IVD devices.
Therefore, the Model SR-115 Portable X-Ray System is a medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.
Product codes
IZL
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
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. 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/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT 3 1 2006
Mr. Ray Menez Director, Operations Source-Ray, Inc. 167 Keyland Court BOHEMIA NY 11716
Re: K062472
Trade/Device Name: RC-115 Optional Remote Control (accessory to SR-115 Portable X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: August 22, 2006 Received: August 31, 2006
Dear Mr. Menez:
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 shows a circular logo with the text "1906-2006 FDA Centennial" inside. The letters "FDA" are prominently displayed in the center of the logo. Three stars are located at the bottom of the logo. The logo is surrounded by a dotted border.
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 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 vours.
Nancy Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Ver/ 3 - 4/24/96
Applicant: Source-Ray, Inc.
510(k) Number (if known):
Device Name: X-Ray System, Portable
Indications For Use: The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)
(Optional Format 1-2
Prescription Use
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K062472
510(k) Number