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K Number
K201575
Device Name
CMDR 2C (Multiple Models)
Manufacturer
MinXray, Inc
Date Cleared
2020-07-08

(27 days)

Product Code
IZLLLZMQB
Regulation Number
892.1720
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.
Device Description
This represents the straightforward combination of three devices: One of three cleared MinXray Portable HF X-ray generators: a) HF120/60H PowerPlus cleared in K040046, (and in K141885) OR b) HF100H+ cleared in K052721 OR C) HF1202 PowerPlus cleared in K153059. d) Plus: A 510(k) cleared (K153058) Digital X-Ray Receptor Panel CareView 1500C X-ray Flat Panel Detector. PLUS: the dicomPACS® software package (Same as our predicate). e) The x-ray generators are portable units which operate from 120/240V 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 the Careray flat panel technology in a sleek and compact unit. The portable panel 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. The only difference between this modified device and our predicate devices is the model number of the digital x-ray receptor panel. The predicate panel can communicate either by wireless or wired connection. The subject device communicates by Ethernet only.
More Information

K191451

K153058

No
The description focuses on the hardware components (X-ray generators, digital panel) and standard software for image handling (dicomPACS®). There is no mention of AI, ML, or advanced image processing beyond basic capture and display. The testing described is focused on hardware compatibility and image quality using standard phantoms, not on evaluating algorithmic performance.

No
The device is described as taking "diagnostic x-rays" and capturing "diagnostic images," which indicates it is used for diagnosis rather than treatment.

Yes
The "Intended Use / Indications for Use" explicitly states that the device is "for taking diagnostic x-rays," and the "Device Description" mentions that the flat panel detector's features "make it easy to capture high quality diagnostic images for routine diagnosis."

No

The device description explicitly states it is a combination of three hardware devices (X-ray generators and a digital X-ray receptor panel) and a software package. The testing also includes hardware components.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "taking diagnostic x-rays" on patients (adult and pediatric). This involves imaging the internal structures of the body using X-rays.
  • Device Description: The device is a combination of an X-ray generator and a digital X-ray receptor panel. These components are used to produce and capture X-ray images of the patient.
  • Input Imaging Modality: The input modality is X-ray, which is an imaging technique applied to the patient's body.
  • Lack of mention of in vitro testing: There is no mention of the device being used to test samples taken from the body (like blood, urine, tissue, etc.) in a laboratory setting.

IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnostic purposes. This device is an in vivo diagnostic imaging device, as it is used to image the patient directly.

N/A

Intended Use / Indications for Use

Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

Product codes (comma separated list FDA assigned to the subject device)

IZL, MQB, LLZ

Device Description

This represents the straightforward combination of three devices: One of three cleared MinXray Portable HF X-ray generators:
a) HF120/60H PowerPlus cleared in K040046, (and in K141885) OR
b) HF100H+ cleared in K052721 OR
c) HF1202 PowerPlus cleared in K153059.
d) Plus: A 510(k) cleared (K153058) Digital X-Ray Receptor Panel CareView 1500C X-ray Flat Panel Detector.
e) PLUS: the dicomPACS® software package (Same as our predicate).

The x-ray generators are portable units which operate from 120/240V 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 the Careray flat panel technology in a sleek and compact unit. The portable panel 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. The only difference between this modified device and our predicate devices is the model number of the digital x-ray receptor panel. The predicate panel can communicate either by wireless or wired connection. The subject device communicates by Ethernet only.

Mentions image processing

Yes

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)

Study Type: Non-clinical testing (bench testing)
Sample Size: Not specified, but involved prototype systems covering all generator/panel combinations.
Key Results:

  • dicomPACS® software installation and functionality verified on Dell Inspiron laptop.
  • Wi-Fi connection confirmed between PerkinElmer panel and Dell laptop (for initial testing, though final device is Ethernet only).
  • Panel charged and turned on confirmed.
  • MinXray HF portable generator turned on and set to generate exposure.
  • Generator aimed at PerkinElmer panel, radiographic phantom placed on panel.
  • Several test exposures showed proper system operation.
  • No modifications necessary to hardware or software other than changing the digital panel.
  • System complies with DHHS radiation safety standards.
  • Tested for compliance with UL 60601-1 (2005) (Electrical medical device safety), IEC 60601-1-2 (2007) (Electromagnetic Compatibility).
  • HF1202H PowerPlus generator meets IEC 60601-2-54.
  • Software compatibility verified with the new CareView Cw digital panel.
  • Risks and hazardous impacts from device modification analyzed by FMEA methodology; specific risk control measures reviewed and implemented.
  • The i.b.a. Test Device DIGI-13 was used to obtain images from both the predicate and the new digital panel. All panel/generator combinations were tested. The images were evaluated and found to be of diagnostic quality.
  • Cybersecurity precautions added to labeling and information obtained from DICOM software supplier.

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.

K191451

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.

K153058

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.

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July 8, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling a symbol. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

MinXray, Inc. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K201575

Trade/Device Name: CMDR 2C (Multiple Models) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB, LLZ Dated: June 10, 2020 Received: June 11, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 of medical device-related adverse events) (21 CFR 803) for

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201575

Device Name CMDR 2C (Multiple Models)

Indications for Use (Describe)

Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: 510(k) Number K201575 MinXray, Inc. 3611 Commercial Avenue Northbrook, Illinois 60062, USA Toll Free 1-800-221-2245 (USA & Canada) Date Prepared: June22, 2020 Contact: Keith Kretchmer, President

    1. Identification of the Device: Trade/Device Name: CMDR 2C (Multiple Models) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB, and LLZ. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
    1. Equivalent legally marketed device: K191451, MinXray, Inc. Trade/Device Name: CMDR 2CW (Multiple Models) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB, and LLZ. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
    1. Reference device (We employ these cleared devices without modification): Trade/Device Name: K153058 CareView 1500C/CareView 1500L X-ray Flat Panel Detectors; Manufacturer: CareRay Digital Medical Systems Co., Ltd Regulation Number: 21 CFR 892. 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB
  • Indications for Use (intended use): These digital radiographic systems are intended for use by a qualified/trained 4) physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.
    1. Description of the Device: This represents the straightforward combination of three devices: One of three cleared MinXray Portable HF X-ray generators:
    • a) HF120/60H PowerPlus cleared in K040046, (and in K141885) OR
    • HF100H+ cleared in K052721 OR b)
    • C) HF1202 PowerPlus cleared in K153059.
    • d) Plus: A 510(k) cleared (K153058) Digital X-Ray Receptor Panel CareView 1500C X-ray Flat Panel Detector.
    • PLUS: the dicomPACS® software package (Same as our predicate). e)

The x-ray generators are portable units which operate from 120/240V 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 the Careray flat panel technology in a sleek and compact unit. The portable panel 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. The only difference between this modified device and our predicate devices is the model number of the digital x-ray receptor panel. The predicate panel can communicate either by wireless or wired connection. The subject device communicates by Ethernet only.

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6) Substantial Equivalence Chart

| Characteristic | Predicate: K191451
CMDR 2CW (Multiple Models) | CMDR 2C (Multiple Models) |
|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Intended for use by a qualified/trained
physician or technician on both adult and
pediatric subjects for taking diagnostic x-
rays. Not for mammography | SAME |
| Configuration | Mobile System with digital x-ray panel and
image acquisition computer | SAME |
| Computer | Dell Precision M3530 or Dell Latitude 7424
(ruggedized) | Dell Precision M3530 or Dell Latitude 7424
(ruggedized) |
| X-ray
Generator(s)
(All made by
Mikasa X-Ray) | HF120/60H PowerPlus (K040046) or
HF100H+ (K052721) or
HF1202H PowerPlus (K153059) | SAME |
| Basic
Generator
Characteristics | 120 VAC Line operated:
HF120/60H PowerPlus™ produces up to 120
kVP and 2.4 kW peak
HF100H+: up to 100 kVp and 2 kW peak
HF1202H PowerPlus: up to 120 kVp up to
3.0 kW peak | SAME |
| Collimator | Collimare LED Collimator | Collimare LED Collimator |
| Generator
Photo(s)
The same
generators will
be used for the
modified device | Image: HF120/60HPPWV | Image: HF100H+
Image: HF1202 H |
| Digital X-ray
Panel Supplied | K150929 CareView 1500Cw X-ray Flat Panel
Detector manufactured by CareRay | K153058 CareView 1500C X-ray Flat Panel
Detector manufactured by CareRay |
| Panel
Performance | Pixel Pitch 154 μm
2304 × 2816 pixels
Size 14" x 17"
(Cleared in K150929)
Csl Scintillator
Spatial Resolution Min. 3.3 line pair/mm
A/D Resolution: 16 bit, 65536 grayscale
MTF - 65% @ 1 lp/mm
DQE Performance: > 65% @ 0 lp/mm | Pixel Pitch 154 μm
2304 × 2816 pixels
Size 14" x 17"
(Cleared in K153058)
Csl Scintillator
Spatial Resolution Min. 3.3 line pair/mm
A/D Resolution: 16 bit, 65536 grayscale
MTF - 65% @ 1 lp/mm
DQE Performance: > 65% @ 0 lp/mm
Note: This panel was cited as the predicate in
K150929. The panels are identical except for the
method of image communication to the host. |
| Panel
Communication | IEEE 802.11a/b/g/n (2.4 GHz /5 GHz) | Gigabit Ethernet |
| Characteristic | Predicate: K191451
CMDR 2CW (Multiple Models) | CMDR 2C (Multiple Models) |
| Panel Power
Source | DC Adapter or Lithium Ion rechargeable
battery | DC Adapter or Lithium Ion rechargeable
battery |
| Panel Interface | Ethernet or Wi-Fi wireless | Ethernet only |
| Meets US
Performance
Standard | YES | YES |
| PACS software | dicomPACS® (Cleared with the Toshiba
panels in K141440) | SAME |
| Power Source | 120 V 50/60 Hz AC 20 amp | SAME |
| Digital Panel
Power Source | 120 V 50/60 Hz AC or Lithium Ion
Rechargeable Battery. | SAME |
| Digital Panel | Image: Digital Panel | Image: Digital Panel |
| Model Details | (All models use O&R Imaging Software with the
Careray Digital Panel and a Dell Laptop) (Five
Models) Model Details: | (All models use O&R Imaging Software with the
Careray Digital Panel and a Dell Laptop) (Five
Models) Model Details: |
| | CMDR.CW.120.60.S for Dell Precision or
CMDR.CW.120.60.R for Dell Latitude Laptop or
equivalent Uses HF120/60HPPWV Generator
with CareView 1500Cw and O&R Imaging
Software | CMDR.C.120.60.S for Dell Precision or
CMDR.C.120.60.R for Dell Latitude Laptop or
equivalent Uses HF120/60HPPWV Generator
with CareView 1500Cw and O&R Imaging
Software |
| | CMDR.CW.100.S for Dell Precision or
CMDR.CW.100.Rfor Dell Latitude Laptop or
equivalent Uses HF100H+ Generator with
CareView 1500Cw and O&R Imaging Software. | CMDR.C.100.S for Dell Precision or
CMDR.C.100.Rfor Dell Latitude Laptop or
equivalent Uses HF100H+ Generator with
CareView 1500Cw and O&R Imaging Software. |
| | CMDR.CW.1202.S for Dell Precision Laptop or
equivalent or
CMDR.CW.1202.R for Dell Latitude Laptop or
equivalent Uses HF1202 Generator with
CareView 1500Cw and O&R Imaging Software | CMDR.C.1202.S for Dell Precision Laptop or
equivalent or
CMDR.C.1202.R for Dell Latitude Laptop or
equivalent Uses HF1202 Generator with
CareView 1500Cw and O&R Imaging Software |
| | CMDR 2CW-MIL (Uses Dell Latitude 7424 or
equivalent with the HF120/60HPPWV Generator
with CareView 1500Cw and O&R Imaging
Software | CMDR 2C-MIL (Uses Dell Latitude 7424 or
equivalent with the HF120/60HPPWV Generator
with CareView 1500Cw and O&R Imaging
Software |

5

6

    1. The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness. Safety and Effectiveness, comparison to predicate device. The results of bench testing indicate that the new devices are as safe and effective as the predicate devices. Proper system operation is fully verified upon installation. We verified that the modified combination of components worked properly and produced diagnostic quality images as good as our predicate generator/panel combination. NO HARDWARE OR SOFTWARE MODIFICATIONS TO ALREADY CLEARED DEVICES WERE REQUIRED TO CREATE THESE NEW MODELS. The main difference from the predicate device is the addition of the CareView 1500 CW flat-panel detector, that replaces the Toshiba and Perkin-Elmer digital imagers used with the predicate system.
    1. Summary of non-clinical testing: Prototype systems covering all generator/panel combinations were assembled and tested. First the dicomPACS® software was installed on the Dell Inspiron laptop computer. The proper installation was verified by running the software. A Wi-Fi connection was confirmed between the PerkinElmer panel and the Dell laptop. The panel was confirmed to be charged and turned on. Then the MinXray HF portable generator was turned on. The MinXray portable X-ray generator was set to generate an exposure. The generator was aimed at the PerkinElmer panel, and a radiographic phantom was placed on the panel. Several test exposures showed that the system was operating properly. No modifications were necessary to any of the hardware or software other than changing the digital panel. The completed system complies with DHHS radiation safety standards currently in effect, and has undergone testing for compliance with UL 60601-1 (2005) (Electrical medical device safety), IEC 60601-1-2 (2007) (Electromagnetic Compatibility). Additionally, the HF1202H PowerPlus generator meets IEC 60601-2-54: Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. The other generators were designed and cleared prior to the isuance of this standard. We verified software compatibility with the new CareView Cw digital panel. The risks and hazardous impacts of the device modification were analyzed by FMEA methodology. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented as part of product design. The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted.

We employed the i.b.a. Test Device DIGI-13, a device for quality tests at CR and DR systems (e.g. for acceptance tests according to DIN V 6868-58 and constancy tests according to DIN 6868-13) to obtain images from both the predicate and the new digital panel. All panel/generator combinations were tested. The images were evaluated and found to be of diagnostic quality.

In recognition of the FDA Guidance on Cybersecurity, we added Cybersecurity precautions to our labeling and obtained Cybersecurity information from our DICOM software supplier Oehm Und Rehbein.

    1. Summary of clinical testing: Clinical testing was not required to establish substantial equivalence.
    1. Conclusion: After analyzing bench and clinical tests, it is the conclusion of MinXray Inc. that the modified Digital Diagnostic X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.