(57 days)
No
The document describes a digital radiography system upgrade and does not mention any AI or ML capabilities.
No
The device is used for taking diagnostic radiographic exposures, not for treating conditions.
No
The device is an imaging system used to take diagnostic radiographic exposures, but it does not diagnose conditions itself. It produces images which a qualified professional would then use for diagnosis.
No
The device description clearly outlines hardware modifications and components, including batteries, a power supply, and enclosure sheet metal, indicating it is a hardware device with integrated digital imaging capabilities.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed 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 this device is a portable X-ray system used for taking radiographic exposures of various body parts. This is an in vivo diagnostic imaging technique, meaning it is performed on a living organism.
- Intended Use: The intended use describes taking diagnostic radiographic exposures, which is a form of medical imaging, not laboratory testing of biological samples.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Product codes (comma separated list FDA assigned to the subject device)
IZL
Device Description
The AMX4-50 is an AMX portable that has been upgraded to accommodate the Canon 50G digital imaging system. The AMX4 will operate in the same manner as before except that, instead of using film cassettes, it will be making digital images with the Canon sensor. The original AMX system is disassembled and reconstructed with new batteries, a DC to AC power supply for the Canon digital imaging system, and enclosure sheet metal to accommodate the modifications. An added control coordinates x-ray exposure and digital image acquisition. The AMX4-50 asses the Canon CXDI-50G and the AMX4-31 uses the Canon CXDI-31 portable detector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts.
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician
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)
The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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 text "EXHIBIT 2 510(k) Summary" at the top. Below the text is a logo for "VIRTUAL IMAGING". The logo consists of a stylized letter V on the left and the words "VIRTUAL IMAGING" in block letters on the right. The text is centered and the logo is aligned with the text.
720 S. Powerline Road S Deerfield Beach, FL 33442 954-428-6191 (Office) 954-428-6195 (Fax) October 18, 2006 Contact: Chris Duca, COO DEC 26 2006
- Identification of the Device: Proprietary-Trade Name: AMX4-50 and AMX4-31 Mobile Digital Diaganatic Radiographic Systems (Also offered as an upgrade kit to owners of the GE AX-4 Plus Mobile X-Ray System: AMX4-550 Retrofit Kit) 、, Classification Names System, x-ray, mobile Product Code Product Code IZL Common/Usual Name: Mobile X-Ray System
-
- Equivalent legally marketed device: GE AMX-4 Plus Mobile X-ray System, K021016 and CANON CXDI-50G Digital Radiography, K031447. The remanufactured device COMBINES these two units with an integrated control. A similar unit in the market would be the Sedecal Mobile X-Ray Units with Digital Detector, K043002.
-
- Indications for Use (intended use) Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the shull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
-
- Description of the Device: The AMX4-50 is an AMX portable that has been upgraded to accommodate the Canon 50G digital imaging system. The AMX4 will operate in the same manner as before except that, instead of using film cassettes, it will be making digital images with the Canon sensor. The original AMX system is disassembled and reconstructed with new batteries, a DC to AC power supply for the Canon digital imaging system, and enclosure sheet metal to accommodate the modifications. An added control coordinates x-ray exposure and digital image acquisition. The AMX4-50 asses the Canon CXDI-50G and the AMX4-31 uses the Canon CXDI-31 portable detector.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.
1
| Characteristic | GE AMX-4 Plus
Mobile X-ray
System, K021016 | Sedecal Mobile
Ray Units with
Digital Detector,
K043002. | AMX4-50 and
AMX4-31 Mobile
Digital Diagnostic
Radiographic
Systems and
AMX4-50 Retrofit
Kit |
|--------------------------|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Mobile diagnostic
x-ray | SAME | SAME |
| Power source | Batteries charged by
AC line | SAME | SAME |
| Image acquisition | X-ray film | Canon Digital Panel
CXDI-50G | Digital Panel
CXDI-50G or the
CXDI-31 portable
detector (K003689/
K023750) |
| User Interface | | Software Driven
Touch Panel LCD | Software Driven
Touch Panel LCD for
Digital Panel,
Generator controls are
NOT modified |
| Digital Resolution | N/A | 160 x 160 microns
pixel pitch, with
approximately 6
million pixels and
4,096 gray scale
contrast | SAME (Combined
device) or 100 x 100
microns for AMX4-
31 with 6.5 million
pixels. 4,096 gray
scale contrast |
| Available panel
sizes | N/A | CXDI-50G
35 x 43 cm | CXDI-50G
35 x 43 cm
CXDI-31
22.6 x 28.8cm |
| Performance
Standard | Complies with 21
CFR Part 1020 | SAME | SAME |
| Electrical safety | UL/IEC | SAME | SAME |
6. Substantial Equivalence Chart, "AMX4-50 and AMS
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of Virtual Imaging that the AMX4-50 and AMX4-31 System is as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUM." written around the top half of the circle. Inside the circle is a symbol that consists of three curved lines that appear to be stacked on top of each other. The seal is black and white and has a simple design.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Virtual Imaging, Inc. % Mr. Daniel Kamm Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015
DEC 26 2006
Re: K063262
Trade/Device Name: AMX4-50 and AMX4-31 Mobile Digital Diagnostic Radiographic System (Also offered as an upgrade kit to owners of the GE AMX-4 Plus Mobile X-Ray
System: AMX4-50 Retrofit Kit)
Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: October 26, 2006 Received: October 31, 2006
Dear Mr. Kamm:
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 commence prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devoces that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Nossmatic Act (Act) that do not require approval of a premarket approval application (PMA), You may cossn. 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 affectively 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/2/Picture/12 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, "PA" in the center, and "Centennial" at the bottom. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
3
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/cdrlvindustry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K063262
Device Name: AMX4-50 and AMX4-31 Mobile Digital Diagnostic Radiographic Systems (Also offered as an upgrade kit to owners of the GE AMX-4 Plus Mobile X-Ray System: AMX4-50 Retrofit Kit)
Indications For Use:
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Prescription Use X (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)
Daniel A. Syzmm
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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