K Number

Validate with FDA (Live)

Device Name

AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR

Manufacturer

AJEX MEDITECH., LTD

Date Cleared

2014-03-28

(605 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K132890,K192462

Predicate For

N/A

Intended Use

This equipment is used for generating X-ray to get the X-ray image for the purpose of diagnosis of patient.

This equipment is possible to move the place for patient because it is designed for portable type.

This equipment is possible to combine with the mobile stand unit for convenience for patient positioning according to user's needs.

The AJEX 1200H/ AJEX 240H Mobile X-ray Generator is designed for the following applications :

Physician with general practice
Bedside exposures in hospital ward
Surgery and Orthopedics

Device Description

The AJEX 1200H and AJEX 240H are portable x-ray units which operate at 110V or 220V, 50/60 HZ. The units have an LED display with up and down soft keys to control KvP. In addition the unit has preset memory keys to store and select KvP. The units can be installed on a mobile stand, a support arm or can be hand held. The unit should be used only by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of body parts. The usual safety precautions regarding the use of x-ray units must be observed by the operator.

AI/ML Overview

The provided text describes a 510(k) premarket notification for two portable X-ray units, the AJEX 1200H and AJEX 240H. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through clinical studies or standalone algorithm performance.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided document, as it falls outside the scope of a typical 510(k) submission for this type of device.

Below is a breakdown of what can be extracted and what information is not available:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to legally marketed predicate devices. This means that the new devices are considered safe and effective if they have the same intended use and similar technological characteristics to the predicate devices, or if any differences do not raise new questions of safety or effectiveness.

The "device performance" in this context is primarily a comparison of technical specifications and performance parameters against the predicate devices.

Characteristic	Acceptance Criterion (Substantially Equivalent to Predicate)	Reported Device Performance (AJEX-1200H)	Reported Device Performance (AJEX-240H)
Intended Use	SAME as Predicate	SAME	SAME
mA	Comparable to Predicate (14-60 mA or 20,25,30 mA)	15-80	15-40
kVp	Comparable to Predicate (40-100 kVp or 40-120 kVp)	40-120	40-120
mAs	Comparable to Predicate (0.6-100 mAs or 0.6-212 mAs)	0.6-168	0.4-140
Focal Spot	Comparable to Predicate (1.2mm)	1.8mm	1.2mm
Power Requirement	Comparable to Predicate	110 or 220V, 50/60Hz	110 or 220V, 50/60Hz
User Interface	SAME as Predicate	Exposure Switch and Console	Exposure Switch and Console
Collimator	SAME (manual)	manual	manual
Size	Comparable to Predicate	13.4" x 9.9" x 9.8"	13.4" x 7.6" x 6.4"
Weight	Comparable to Predicate	44lbs	32lbs

The conclusion states: "After analyzing all the data it is the conclusion of JPI that the AJEX-1200H and 240H are as safe and effective as the predicate devise. The systems have few technological differences, and have no new indication for use. thus rendering them substantially equivalent to the predicate devices."

Study Information Not Applicable/Available:

The provided document is a 510(k) summary for X-ray units, not an AI/algorithm-driven device. Therefore, a "study" in the sense of a clinical trial proving diagnostic performance against specific metrics with human readers or standalone AI performance is not detailed. The "study" here is primarily a technical comparison to predicate devices, supported by the engineering and design choices.

Sample size used for the test set and the data provenance: Not applicable. This is a submission for a hardware device (X-ray unit), not an algorithm or diagnostic imaging study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic image interpretation is not relevant for the substantial equivalence of an X-ray generator.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. The device is an X-ray generator, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable. There is no "training set" in the context of an X-ray generator's substantial equivalence demonstration.
How the ground truth for the training set was established: Not applicable.

Summary

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K122298
Pag 1 of 2

EXHIBIT 4 (Page 1 of 2) 510 (k) Summary

June 14, 2013

l. Submitter:

Company: JPI Healthcare Solutions 52 Newtown Plaza Plainview, NY 11803 516-513-1330 ext 108 Telephone: William Little Contact:

Identification of Device:

Proprietary-Trade Name: AJEX 1200H and AJEX 240H Portable X-ray Units Mobile X-ray System Classification Name: Product Code: 90 IZL Portable general Purpose X-ray Unit. Common/Usual Name:

Equivalent Marketed Devise:

This product is substantially equivalent to the MinX-ray HF100+ and HF120/610Hz PowerPlus Portable X-ray units (Predicate Device), which have been found to be substantially equivalent through the 510 (k) premarket notification process.

Description of Device:

Intended Use of AJEX 1200H AND AJEX 240H: న్.

This equipment is used for generating X-ray to get the X-ray image for the purpose of diagnosis of patient.

This equipment is possible to move the place for patient because it is designed for portable type.

This equipment is possible to combine with the mobile stand unit for convenience for patient positioning according to user's needs.

The AJEX 1200H/ AJEX 240H Mobile X-ray Generator is designed for the following applications :

Physician with general practice
Bedside exposures in hospital ward
Surgery and orthopedics

{1}------------------------------------------------

K122298
page 2 of 2

EXHIBIT 4 (Page 2 of 2) 510 (k) Summary

6. Substantial Equivalence Chart

Characteristics	HF100+	HF120/60HzPowerPlus	AJEX-1200H	AJEX-240H
Intended use.	SAME	SAME	SAME	SAME
MA	20,25,30	14-60	15-80	15-40
kVp	40-100	40-120	40-120	40-120
mAs	0.6-100	0.6-212	0.6-168	0.4-140
Focal Spot	1.2mm	1.2mm	1.8mm	1.2mm
Powerrequirement	100-140VACor 200-260VAC,50/60Hz	100-260VAC,50/60Hz	110 or 220V,50/60Hz	110 or 220V,50/60Hz
User Interface	ExposureSwitch andConsole	Exposure Switchand Console	ExposureSwitch andConsole	Exposure Switchand Console
Collimator	manual	manual	manual	manual
Size	9.5"x 8.75" x16"	16"x8.8"x9.5"	13.4" x 9.9" x9.8"	13.4" x 7.6" x 6.4"
Weight	45.5lbs	38.6lbs	44lbs	32lbs

Conclusion:

After analyzing all the data it is the conclusion of JPI that the AJEX-1200H and 240H are as safe and effective as the predicate devise. The systems have few technological differences, and have no new indication for use. thus rendering them substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public" on the top line, "Health" on the second line, and "Service" on the third line. The text appears to be extracted from a document or sign.

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

March 28, 2014

AJEX Meditech, Ltd. % Mr. William Little Product Manager JPI Healthcare Solutions, Inc. 52 Newtown Plaza PLAINVIEW NY 11803

Re: K122298

Trade/Device Name: AJEX 1200H and AJEX 240H Portable X-ray Units Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: November 8, 2013 Received: November 12, 2013

Dear Mr. Little:

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 device-related adverse events) (21 CFR 803); 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.

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Page 2-Mr. Little

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

http://www.fda.gov/MedicalDevices/Resources.for You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Smh.f)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K122298

Device Name

AJEX 1200H I AJEX 240H Mobile X-ray Generator

Indications for Use (Describe) This equipment is used for generating X-ray to get the X-ray image for the purpose of diagnosis of patient.

This equipment is possible to move the place for patient because it is designed for portable type.

This equipment is possible to combine with the mobile stand unit for convenience for patient positioning according to user's needs.

The AJEX 1200H/ AJEX 240H Mobile X-ray Generator is designed for the following applications :

Physician with general practice
Bedside exposures in hospital ward
Surgery and Orthopedics

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 Heatth (CDRH) (Signature)

Smh. 7)

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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.