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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MinXray HF1202H PowerPlus™ Portable X-ray Equipment, seeking substantial equivalence to a predicate device. This document does not describe a study that uses AI or machine learning, nor does it provide acceptance criteria and performance data in the typical sense for such devices (e.g., sensitivity, specificity, AUC).

Instead, this document describes a traditional medical device (an X-ray machine) and its comparison to a legally marketed predicate device. The core of the equivalence claim is based on bench testing and compliance with recognized standards, rather than performance metrics on a clinical image test set adjudicated by experts.

Therefore, for your requested information:

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" here are compliance with various IEC standards and demonstrating functional equivalence to the predicate device. The "reported device performance" is the conclusion of compliance with these standards and the comparison of specifications presented in the table on pages 3-4.

Acceptance Criteria (Implied by 510(k))	Reported Device Performance
Compliance with IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012)	Test results showed compliance with these standards.
Compliance with IEC 60601-1-2:2007	Test results showed compliance with these standards.
Compliance with IEC 60601-1-3:2008 (Second Edition)	Test results showed compliance with these standards.
Compliance with IEC 60601-1-6:2010 (Third Edition)	Test results showed compliance with these standards.
Compliance with IEC 60601-2-28:2010 (Second Edition)	Test results showed compliance with these standards.
Compliance with IEC 60601-2-54 (First Edition): 2009	Test results showed compliance with these standards.
Compliance with IEC 62304:2006 (First Edition)	Test results showed compliance with these standards.
Compliance with IEC 62366: 2007 (First Edition) + A1: 2014	Test results showed compliance with these standards.
Software validation and risk analysis performed	Performed.
Overall operation verified (taking and reviewing test images)	Confirmed.
Functional equivalence to predicate device K040046 MinXray HF120/60 PowerPlus™	Demonstrated through specifications comparison (see table).
FCC approval for Bluetooth® module	Bluetooth® module is FCC approved and validated.

2. Sample size used for the test set and the data provenance

Not applicable. The "test set" was not a collection of clinical images or patient data but rather the physical device tested against engineering standards and specifications. The document mentions "test images" were reviewed for overall operation, but no specific sample size of these images or their provenance is provided, as they were not used to establish clinical performance metrics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of clinical performance evaluation by experts, was not established for this type of device submission. The evaluation was primarily based on engineering compliance and functional specifications.

4. Adjudication method for the test set

Not applicable, as there was no expert adjudication of a test set of clinical cases.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a portable X-ray machine, not an AI or CAD system. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission refers to the established engineering standards, regulatory requirements, and the specifications of the predicate device. It's based on technical compliance and functional equivalence rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device is not an AI/Machine Learning system, so there is no training set in the conventional sense.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

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

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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)

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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 HF120/60PowerPlus™, made by Mikasa X-RayCo. Ltd. (made for MinXray)	HF1202H PowerPlus™ Portable X-RayEquipment
Intended Use:	This radiographic system is intendedfor use by a qualified/trained physicianor technician on both adult andpediatric subjects for taking diagnosticx-rays. (Not for mammographic use.Language later required by FDA)	(SAME) This radiographic system is intended foruse by a qualified/trained physician ortechnician on both adult and pediatric subjectsfor taking diagnostic x-rays. Not formammographic 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 HF120/60PowerPlus,™ made by Mikasa X-RayCo. Ltd. (made for MinXray)	HF1202H PowerPlus™ Portable X-RayEquipment
Use Interface:	Up-Down pushbuttons for kVpselections and exposure timeselections and exposure timeselections with LED indicators mAsindicator.	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 kVDC50 mA(0.01-0.1sec),35 mA (0.11–5.0sec) @ 52 - 60 kVDC45 mA(0.01-0.1sec),31.5 mA (0.11–5.0sec) @ 62 - 70 kVDC38 mA(0.01-0.1sec),26.6 mA (0.11–5.0sec) @ 72 - 80 kVDC33 mA(0.01-0.1sec),23.1 mA (0.11–5.0sec) @ 82 - 90 kVDC30 mA(0.01-0.1sec),21 mA (0.11–5.0sec) @ 92 - 100 kVDC20 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 kVDC55 mA(0.02-0.05sec),41.3mA (0.06 -0.2sec),30.3 mA(0.22-5.0sec), @ 62 - 70 kVDC50 mA(0.02-0.05sec),37.5mA (0.06 -0.2sec),27.5 mA(0.22-5.0sec), @ 72 - 80 kVDC45 mA(0.02-0.05sec),33.8mA (0.06 - 0.2sec),24.8 mA(0.22-5.0sec), @ 82 - 90 kVDC40 mA(0.02-0.05sec),30.0mA (0.06 - 0.2sec),22.0 mA(0.22-5.0sec), @ 92 - 100 kVDC30 mA(0.02-0.05sec),22.5mA (0.06-0.2sec),16.5 mA(0.22-5.0sec), @ 102 - 110 kVDC25 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 CompanySXR-130 1.2 mm, 65 kHU	SAME
Collimator	Advantech	Collimare®
SerialCommunication	Not available	RS-232 or Bluetooth for communication oftechnique factors to a PC.
	K040046, MinXray HF120/60PowerPlus™, made by Mikasa X-RayCo. Ltd. (made for MinXray)	HF1202H PowerPlus™ Portable X-RayEquipment
Photo	Image: K040046, MinXray HF120/60 PowerPlus	Image: HF1202H PowerPlus Portable X-Ray Equipment

7. Substantial Equivalence Chart

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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.

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.