Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the hardware components and communication protocols for transmitting technique factors, with no mention of AI/ML for image processing or analysis.

Therapeutic

No
The "Intended Use / Indications for Use" section states that the system is for "taking diagnostic x-rays," which indicates a diagnostic rather than a therapeutic purpose.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the system is for "taking diagnostic x-rays," indicating its role in diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple hardware components including an X-ray generator, collimator, mounting trunnion, exposure cord, and AC power cord. While it mentions communication with a PC using FDA cleared software, the core device is a physical radiographic system.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Description and Intended Use: The description clearly states this is a "radiographic system" intended for "taking diagnostic x-rays" on "adult and pediatric subjects." X-rays are a form of medical imaging that examines the inside of the body without taking specimens.
Lack of Specimen Handling: The device description does not mention any components or processes related to collecting, handling, or analyzing biological specimens.

Therefore, based on the provided information, this device is a medical imaging device, specifically an X-ray system, and not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.

Product codes

IZL

Device Description

The MinXray HF1202 consists of an X-ray generator (tubehead/control), continuously adjustable light beam collimator, mounting trunnion, exposure cord with 2-stage exposure switch, and AC power cord. If a stand is purchased with the HF1202, such as the MinXray XGS series of gas spring portable mobile stands, instructions for assembly of the stand and the attachment of the HF1202 are included with the stand. This is a high-frequency generator of updated design. The unit has a serial port and a Bluetooth port for communication of technique factors to a PC. The PC cannot initiate an exposure. When used, the PC must employ FDA cleared software and digital receptor panels. Known compatible with Toshiba FDX4343RP and FDX4343RPW digital x-ray panels. The FDX4343RP was cleared in K130883 (and K131211) and the FDX4343RPW was cleared in K143257.

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

Bench testing was performed to indicate that the new device is as safe and effective as the predicate device. Proper system operation is fully verified upon installation.
Non-clinical testing was performed according to the following standards: IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012), IEC 60601-1-2:2007, IEC 60601-1-3:2008, IEC 60601-1-6:2010, IEC 60601-2-28:2010, IEC 60601-2-54: 2009, IEC 62304:2006, IEC 62366: 2007 + A1: 2014. The test results showed compliance with these standards. Overall operation was also confirmed by taking and reviewing test images. The Bluetooth® module is FCC approved and was validated for use with the HF1202H.
Clinical testing was not applicable and was not deemed necessary to show substantial equivalence.

Key Metrics

Not Found

Predicate Device(s)

K040046

Reference Device(s)

K130883, K131211, K143257

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/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 a human figure, represented by three overlapping profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 2, 2016

MinXray, Inc. % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114

Re: K153059

Trade/Device Name: HF1202H PowerPlus™ Portable X-ray Equipment Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: October 19, 2015 Received: October 21, 2015

Dear Daniel 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ochs

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153059

Device Name

HF1202H PowerPlus(tm) Portable X-ray Equipment

Indications for Use (Describe)

This radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary: 510(k) Number K153059 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: January 25, 2016 Keith Kretchmer, President Contact:

1. Identification of the Device: Proprietary-Trade Name: HF1202H PowerPlus™ Portable X-Ray Equipment
Classification Name: Mobile x-ray system, Product Code IZL Regulation Number 892.1720 2. Common/Usual Name: Mobile Diagnostic X-Ray System
1. Equivalent legally marketed device: K040046, MinXray HF120/60 PowerPlus,™ made by Mikasa X-Ray Co. Ltd. (for MinXray). Mobile x-ray system, Product Code IZL Regulation Number 892.1720
Indications for Use (intended use): This radiographic system is 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: The MinXray HF1202 consists of an X-ray generator (tubehead/control), continuously adjustable light beam collimator, mounting trunnion, exposure cord with 2-stage exposure switch, and AC power cord. If a stand is purchased with the HF1202, such as the MinXray XGS series of gas spring portable mobile stands, instructions for assembly of the stand and the attachment of the HF1202 are included with the stand. This is a high-frequency generator of updated design. The unit has a serial port and a Bluetooth port for communication of technique factors to a PC. The PC cannot initiate an exposure. When used, the PC must employ FDA cleared software and digital receptor panels. Known compatible with Toshiba FDX4343RP and FDX4343RPW digital x-ray panels. The FDX4343RP was cleared in K130883 (and K131211) and the FDX4343RPW was cleared in K143257.
1. Safety and Effectiveness, comparison to predicate device. The results of bench testing indicates that the new device is as safe and effective as the predicate device. Proper system operation is fully verified upon installation.

| | K040046, MinXray HF120/60
PowerPlus™, made by Mikasa X-Ray
Co. Ltd. (made for MinXray) | HF1202H PowerPlus™ Portable X-Ray
Equipment |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | This radiographic system is intended
for use by a qualified/trained physician
or technician on both adult and
pediatric subjects for taking diagnostic
x-rays. (Not for mammographic use.
Language later required by FDA) | (SAME) This radiographic system is intended for
use by a qualified/trained physician or
technician on both adult and pediatric subjects
for taking diagnostic x-rays. Not for
mammographic use. |
| Size / weight: | 453 x 292 x 224 mm 17.94kgs | 460 x 305 x 225 mm 19.5kgs |
| Energy Source: | 120V 50 - 60AC | SAME |
| | K040046, MinXray HF120/60
PowerPlus,™ made by Mikasa X-Ray
Co. Ltd. (made for MinXray) | HF1202H PowerPlus™ Portable X-Ray
Equipment |
| Use Interface: | Up-Down pushbuttons for kVp
selections and exposure time
selections and exposure time
selections with LED indicators mAs
indicator. | SAME |
| Exposure times: | (0.01–0.2sec) in 0.01sec. Step
(0.2-0.4sec) in 0.02sec. Step
(0.4-1.0sec) in 0.05sec Step
(1.0-5.0sec) in 0.1sec Step | (0.02–0.2sec) in 0.01sec. Step
(0.2-0.4sec) in 0.02sec. Step
(0.4-1.0sec) in 0.05sec Step
(1.0-5.0sec) in 0.1sec Step |
| mA: | 60 mA(0.01-0.1sec),
42 mA (0.11–5.0sec) @ 40 - 50 kVDC
50 mA(0.01-0.1sec),
35 mA (0.11–5.0sec) @ 52 - 60 kVDC
45 mA(0.01-0.1sec),
31.5 mA (0.11–5.0sec) @ 62 - 70 kVDC
38 mA(0.01-0.1sec),
26.6 mA (0.11–5.0sec) @ 72 - 80 kVDC
33 mA(0.01-0.1sec),
23.1 mA (0.11–5.0sec) @ 82 - 90 kVDC
30 mA(0.01-0.1sec),
21 mA (0.11–5.0sec) @ 92 - 100 kVDC
20 mA(0.01-0.1sec),
14 mA (0.11–5.0sec) @ 102 - 120 kVDC | 60 mA(0.02-0.05sec),
45mA (0.06 -0.2sec),
33 mA(0.22-5.0sec), @ 40 - 60 kVDC
55 mA(0.02-0.05sec),
41.3mA (0.06 -0.2sec),
30.3 mA(0.22-5.0sec), @ 62 - 70 kVDC
50 mA(0.02-0.05sec),
37.5mA (0.06 -0.2sec),
27.5 mA(0.22-5.0sec), @ 72 - 80 kVDC
45 mA(0.02-0.05sec),
33.8mA (0.06 - 0.2sec),
24.8 mA(0.22-5.0sec), @ 82 - 90 kVDC
40 mA(0.02-0.05sec),
30.0mA (0.06 - 0.2sec),
22.0 mA(0.22-5.0sec), @ 92 - 100 kVDC
30 mA(0.02-0.05sec),
22.5mA (0.06-0.2sec),
16.5 mA(0.22-5.0sec), @ 102 - 110 kVDC
25 mA(0.02-0.05sec),
18.8mA (0.06-0.2sec),
13.8 mA(0.22-5.0sec), @ 112 - 120 kVDC |
| Memory settings
(technique) | 5 memories via pushbutton | 10 memories via pushbutton |
| HF Generator | 85 kHz | SAME |
| kW | 2.4 kW peak | 3.0 kW peak |
| kVp: | 40 – 120kVp | SAME |
| X-ray Tube | Superior X-ray Tube Company
SXR-130 1.2 mm, 65 kHU | SAME |
| Collimator | Advantech | Collimare® |
| Serial
Communication | Not available | RS-232 or Bluetooth for communication of
technique factors to a PC. |
| | K040046, MinXray HF120/60
PowerPlus™, made by Mikasa X-Ray
Co. Ltd. (made for MinXray) | HF1202H PowerPlus™ Portable X-Ray
Equipment |
| Photo | Image: K040046, MinXray HF120/60 PowerPlus | Image: HF1202H PowerPlus Portable X-Ray Equipment |

7. Substantial Equivalence Chart

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5

1. Summary of non-clinical testing: Software validation and risk analysis was performed. Laboratory testing was performed according to the following standards:
  IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) Medical Electrical Equipment, Part 1: General Requirements for Safety

IEC 60601-1-2:2007 Medical Electrical Equipment-Part 1-2: General Requirements for Safety - 2. Collateral Standard-Electromagnetic compatibility - Requirements and tests

IEC 60601-1-3:2008 (Second Edition) for use with IEC 60601-1: 2005 (Third Edition) Medical electrical equipment Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment IEC 60601-1-6:2010 (Third Edition) for use in conjunction with IEC 60601-1: 2005 (Third Edition)Medical electrical equipment Part 1-6: General requirements for safety - Collateral Standard: Usability including IEC 62366: Application of usability engineering to medical devices

IEC 60601-2-28:2010 (Second Edition) for use in conjunction with IEC 60601-1: 2005 (Third edition) Medical electrical equipment Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

IEC 60601-2-54 (First Edition): 2009 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy IEC 62304:2006 (First Edition) Medical device software: Software life-cycle processes IEC 62366: 2007 (First Edition) + A1: 2014 Medical devices – Application of usability engineering to medical devices. The test results showed compliance with these standards. We also confirmed overall operation by taking and reviewing test images; however, sample clinical images were not required to determine substantial equivalence. The Bluetooth® module is FCC approved and was validated for use with the HF1202H.

1. Summary of clinical testing: Not applicable. Clinical testing was not deemed to show substantial equivalence. We relied on non-clinical testing and compliance with standards.
1. Conclusion: After analyzing bench tests, it is the conclusion of MinXray Inc. that the HF1202H PowerPlus™ Portable X-Ray Equipment is as safe and effective as the predicate device, has the same indications for use, has few technological differences, which are addressed through performance testing and compliance with the standards listed above, thus rendering it substantially equivalent to the predicate device.