(160 days)
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Not Found
No
The summary does not mention AI, ML, or any related technologies, and the device description is not provided.
No.
The device is described as an X-Ray system used for examination and taking X-ray pictures, which are diagnostic purposes, not therapeutic (treatment) purposes.
Yes
Exposure to X-rays is part of the diagnostic process. This device is an X-ray system.
No
The device is described as a "portable X-Ray system," which inherently involves hardware components for generating X-rays. The description focuses on the physical portability and use cases of the X-ray machine itself, not on a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the PXP-HF family of systems are "portable X-Ray systems" used for "general radiographic application." They are used to take X-ray pictures of patients.
- Lack of IVD Characteristics: There is no mention of the device analyzing biological samples, performing laboratory tests, or providing diagnostic information based on in vitro analysis.
The device is an imaging device used for diagnostic purposes, but it operates by generating X-rays and capturing images, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
PXP-HF family of portable X-Ray systems are designed for a general radiographic application in a field or medical clinics use. There are only difference in radiation output and x-ray tube between the portable X-Ray systems.
PXP-20HF and PXP-40HF portables are used with mobile stand systems for Nursing home-care or Private home-care application. When the patients are sick at home, it is very expensive to bring the patients to a hospital by ambulance transportation service for X-ray examination. Therefore hospital sends this portable equipment to the patient's houses and take a X-ray picture on site. This portable and mobile systems has been used on a battle field because of easy mobility,
PXP-15HF portable X-ray systems has been used for Foot & Hand- care clinics or sport medicine group in sport complex or sport stadium for X-ray examination of athletics who are injured during a game.
Product codes
90 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
medical clinics, field, Nursing home-care, Private home-care, battle field, Foot & Hand- care clinics, sport medicine group, sport complex, sport stadium
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 2 2004
Mr. John Lee President United Radiology Systems, Inc. 151 South Pfingsten Road, Unit T DEERFIELD IL 60015
Re: K032628
Trade/Device Name: PXP-HF 15/20/40 Portable X-Ray Regulation Number: 21 CFR 892.1720 Regulation Name: Mobil x-ray system Regulatory Class: II Product Code: 90 IZL Dated: December 15, 2003 Received: December 16, 2003
Dear Mr. Lec:
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 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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name: PXP-HF 15/20/40 PORTABLE X-RAY SYSTEMS
Indications For Use:
PXP-HF family of portable X-Ray systems are designed for a general radiographic application in a field or medical clinics use. There are only difference in radiation output and x-ray tube between the portable X-Ray systems.
PXP-20HF and PXP-40HF portables are used with mobile stand systems for Nursing home-care or Private home-care application. When the patients are sick at home, it is very expensive to bring the patients to a hospital by ambulance transportation service for X-ray examination. Therefore hospital sends this portable equipment to the patient's houses and take a X-ray picture on site. This portable and mobile systems has been used on a battle field because of easy mobility,
PXP-15HF portable X-ray systems has been used for Foot & Hand- care clinics or sport medicine group in sport complex or sport stadium for X-ray examination of athletics who are injured during a game.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David H. Legum
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devic 510(k) Number.
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