(80 days)
No
The summary does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.
No
The device is used for generating radiographic images for diagnostic procedures, not for therapy.
Yes
The "Intended Use / Indications for Use" section states: "The AMX-4 Plus Mobile X-ray System is indicated for use in generating radiographic images of human anatomy in all general purpose X-ray diagnostic procedures." The term "diagnostic procedures" clearly indicates its role as a diagnostic device.
No
The device description explicitly lists hardware components such as an X-ray Generator and Control, X-ray Tube, and Beam Limiting Device, indicating it is a hardware-based system, not software-only.
No, 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. These tests are performed outside of the body (in vitro).
- Device Function: The AMX-4 Plus Mobile X-ray System generates radiographic images of human anatomy. This is a form of in vivo (within the body) imaging. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "generating radiographic images of human anatomy." This aligns with imaging, not laboratory testing of samples.
Therefore, based on the provided information, the AMX-4 Plus Mobile X-ray System is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AMX-4 Plus Mobile X-ray System is indicated for use in generating radiographic images of human anatomy in all general purpose X-ray diagnostic procedures. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, pediatrics, orthopedics and clinics.
Product codes
90 IZL
Device Description
The AMX-4 Plus Mobile X-ray System consists of an X-ray Generator and Control, X-ray Tube, Beam Limiting Device and a new option called the Dose Area Product meter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiology departments, emergency rooms, intensive care units, operating rooms, pediatrics, orthopedics and clinics
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters and the circle are in black, creating a strong contrast. The logo is a well-known symbol associated with the General Electric company.
JUN 1 7 2002
GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201 USA
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Pat 807.87(h).
| Identification of Submitter: | Larry A. Kroger, Ph.D.
Senior Regulatory Programs Manager
GE Medical Systems
Tel. (414) 544-3894
Summary prepared: 21 March, 2002 |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of Product: | AMX-4 Plus Mobile X-Ray System |
| Classification Name: | Mobile X-ray System |
| Manufacturer: | GE Medical Systems
3000 N. Grandview Blvd.
Waukesha, WI 53118 |
| Device Description: | The AMX-4 Plus Mobile X-ray System consists of an X-ray
Generator and Control, X-ray Tube, Beam Limiting Device and a
new option called the Dose Area Product meter. |
| Indications for Use: | The AMX-4 Plus Mobile X-ray System is designed to perform
radiographic x-ray examinations. |
| Comparison with: | AMX-4 Plus Mobile X-ray System is substantially equivalent to
the AMX-3 Mobile X-ray System, K802047. |
| Conformance: | The AMX-4 Plus Mobile X-ray System will conform to applicable
sections of 21CFR 1020.30 and 1020.31. The system will also
conform to UL 2601-1, IEC 601-1, IEC 601-1-2, and IEC 601-1-3. |
| Conclusions: | In the opinion of GE Medical Systems, the AMX-4 Plus Mobile X-
ray System is substantially equivalent to the previously marketed
AMX-3 Mobile X-ray System, K802047. The AMX-4 Plus does
not include any new indications for use, nor does use of this
device result in any new potential hazards. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2002
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414. W-709 MILWAUKEE WI 53201
Re: K021016
Trade/Device Name: AMX-4 Plus Mobile X-Ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: 90 IZL Dated: March 27, 2002 Received: March 29, 2002
Dear Dr. Kroger:
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); 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.
2
This letter will allow you to begin marketing your device as described in your 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:
| 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" (21 CFR Part 807.97). 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/dsmaldsmamain.html.
Sincerely yours,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STATEMENT OF INTENDED USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: AMX-4 Plus Mobile X-ray System
Indications for Use
The AMX-4 Plus Mobile X-ray System is indicated for use in generating radiographic images of human anatomy in all general purpose X-ray diagnostic procedures. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, pediatrics, orthopedics and clinics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801-109)
OR Over-The-Counter Use
Vorint A. Sipeon
(Division Sign-Off)
Division of Reproductive, Ab and Radiological Devi 510(k) Number