(125 days)
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No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
No
The device is described as a Portable X-Ray System intended for radiographic applications, which suggests it is an imaging device for diagnosis rather than a therapeutic device.
No
The device description states it is a "Portable X-Ray System intended for General Purpose Portable Radiographic Applications," indicating it captures images rather than interpreting them for diagnosis.
No
The device is described as a "Portable X-Ray System," which inherently implies hardware components for generating and capturing X-rays. The summary does not mention any software-only functionality.
Based on the provided information, the Model PowerMax 1260 Portable X-Ray System 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 a form of in vivo (within a living organism) diagnostic imaging.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro).
The description clearly indicates a device used for imaging the body directly, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
The Model PowerMax 1260 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
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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 circular seal on the left and a stylized symbol on the right. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ray Manez Director. Operations Source-Ray, Inc. 167 Keyland Court BOHEMIA NY 11716
Re: K090655
Trade/Device Name: PowerMax 1260 Portable X-Ray System Regulation Number: 21CFR §892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: May 29, 2009 Received: June 2, 2009
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 (PMA), it may be subject to 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); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/cdrh/industry/support/index.html.
Sincerely yours,
Jadine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Form (Text Version)
Medical Devices
Indications for Use
510(k) Number (if known): K090655
Device Name: _PowerMax 1260 Portable X-Ray System
Indications for Use:
The Model PowerMax 1260 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications
| Prescription Use | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (Part 21 CFR |
801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number