(38 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing or performance studies that would typically be associated with AI/ML in medical imaging.
No
The device is described as a "Digital Portable X-Ray System" used for "Radiographic Applications," which indicates its function is for imaging/diagnosis, not for treating a disease or condition.
No
The device is a portable X-Ray system for radiographic applications, which suggests it is an imaging device for observation rather than diagnosis. The provided information does not mention any diagnostic capabilities or intended diagnostic use.
No
The intended use clearly describes a "Digital Portable X-Ray System," which is a hardware device. The lack of a device description doesn't negate this.
Based on the provided information, the Model SR-130-D Digital Portable X-Ray System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Portable Radiographic Applications," which involves taking X-ray images of the body. This is an in vivo (within the living body) diagnostic imaging procedure, not an in vitro (outside the living body) test performed on biological samples.
- Device Type: X-ray systems are imaging devices used to visualize internal structures of the body. IVDs are typically reagents, instruments, or systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
The information provided clearly points to a device used for medical imaging of a patient, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Model SR-130-D Digital Portable X-Ray System is The Model OR Too E Portable Radiographic Applications.
Product codes
90 IZL
Device Description
Portable Digital X-Ray System Model SR-130-D
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
Not Found
Intended User / Care Setting
Not Found
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)
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (DHHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the left.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2004
Mr. Ray Manez Director, Operations Source-Ray, Inc. 167 Keyland Court BOHEMIA NY 11716 Re: K043062
Trade/Device Name: Portable Digital X-Ray System Model SR-130-D Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: 90 IZL Dated: November 2, 2004 Received: November 8, 2004
Dear Mr. Manez:
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 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.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 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/cdrb/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
Ver/ 3 - 4/24/96
Applicant: Source-Ray, Inc.
510(k) Number: K043062
Device Name: X-Ray System, Digital Portable
Indications For Use: The Model SR-130-D Digital Portable X-Ray System is The Model OR Too E 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)
Prescription Use
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________