(59 days)
No
The description focuses on the integration of existing, cleared devices and their physical and operational characteristics. There is no mention of AI, ML, or advanced image processing beyond standard digital radiography capture.
No
The device is described as a "digital radiographic system" intended for "taking diagnostic x-rays," which points to diagnostic imaging rather than therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is used for "taking diagnostic x-rays," and the "Device Description" section mentions it's designed to "capture high quality diagnostic images for routine diagnosis."
No
The device description explicitly states it is a "digital radiographic system" and describes the interconnection of two FDA-cleared hardware devices: an X-ray generator and a digital imager. It does not describe a software-only component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device is a digital radiographic system that takes X-ray images of the human body directly.
- The intended use clearly states it's for taking diagnostic x-rays on adult and pediatric subjects. This involves imaging the internal structures of the body, not analyzing biological samples.
- The device description details the components of an X-ray system (generator, imager). These are components used for generating and capturing X-ray images, not for performing laboratory tests on specimens.
The information provided describes a medical imaging device, specifically a digital X-ray system, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.
Product codes (comma separated list FDA assigned to the subject device)
90 IZL, 90 MQB
Device Description
This represents the straightforward interconnection of two FDA cleared devices: The MinXray HF120/60H PowerPlus™ (K040046) and the Canon CXDI-50G Solid State Imager (K031447). MinXray HF120/60H PowerPlus™ is a portable unit which operates from 120 V 50-60~ AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features Canon's large-area flat panel technology in a sleek and compact unit. The portable CXDI-50G provides digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained physician 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 testing indicates that the new device is as safe and cffective as the predicate devices. Proper system operation is fully verified upon installation.
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.
K042361 DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D, SEDECAL USA, INC
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
510(k) Summary 510(k) Number Ko82627 MinXray, Inc. 3611 Commercial Avenue -Northbrook, Illinois 60062, USA Toll Free 1-800-221-2245 (USA & Canada) Tel. 1-847-564-0323 Fax 1-847-564-9040 Date Prepared: September 4, 2008 Keith Kretchmer, President Contact:
-
- Identification of the Device: Proprietary-Trade Name: CMDR-1S Digital Diagnostic X-Ray System (Mobile)
-
- Classification Name: Mobile x-ray system, Product Code 90 IZL and Solid State X-Ray Imager (Flat Pancl/Digital Imager) 90 MQB, Common/Usual Name: Digital Mobile Diagnostic X-Ray System
-
- Equivalent legally marketed device: 510(k) Number K042361 DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D, SEDECAL USA, INC
-
- Indications for Use (intended use) This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.
-
- Description of the Device: This represents the straightforward interconnection of two FDA cleared devices: The MinXray HF120/60H PowerPlus™ (K040046) and the Canon CXDI-50G Solid State Imager (K031447). MinXray HF120/60H PowerPlus™ is a portable unit which operates from 120 V 50-60~ AC. The generator unit utilizes a high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. The digital panel features Canon's large-area flat panel technology in a sleek and compact unit. The portable CXDI-50G provides digital X-ray image capture for a wide range of applications. The lightweight design, generous imaging area, and fast processing times of the detector make it easy to capture high quality diagnostic images for routine diagnosis, as well as challenging trauma and bedside exams. It's a portable solution for a faster, more streamlined approach to digital radiography.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench testing indicates that the new device is as safe and cffective as the predicate devices. Proper system operation is fully verified upon installation.
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7. Substantial Equivalence Chart
| Characteristic | 510(k) Number K042361 DIGITAL
PORTABLE X-RAY UNITS, MODEL
SP-HF-4.0 D, Applicant SEDECAL
USA, INC | CMDR-1S Digital
Diagnostic X-Ray System
(Mobile) |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Intended Use: | Intended for use by a qualified/trained
physician or technician on both adult
and pediatric subjects for taking
diagnostic x-rays. | SAME |
| Configuration | Mobile System | SAME |
| Generator | High Frequency | SAME |
| Performance Standard | 21 CFR 1020.30 | SAME |
| Generator | High frequency made by Sedecal in
Spain, 300 khz. | Uses high frequency
generator made by Mikasa
X-Ray in Japan. 80 khz. |
| Power Source | 120 V 50/60 Hz AC 20 amp | SAME |
| Digital Panel | CANON CXDI 50G | SAME |
7. Conclusion
After analyzing bench tests, it is the conclusion of MinXray Inc that the MinXray CMDR-1S Digital Diagnostic X-Ray System is as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering it substantially cquivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body. The overall design is simple and recognizable, representing the department's role in health and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2008
MinXray, Inc. % Mr. Daniel Kamm. P.E. Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015
Re: K082627
Trade/Device Name: CMDR-1S Digital Diagnostic X-Ray System (Mobile) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: September 5, 2008 Received: September 13, 2008
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 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.
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Page 2
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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
hope M. thang
Joyce M. Whang, Ph.D. Acting 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): K082627 - - - - - - - - -
Device Name: CMDR-1S Digital Diagnostic X-Ray System (Mobile)
Indications For Use:
This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays ..
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)
Hala Leen
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device
510(k) Number .
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