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

{0}------------------------------------------------ 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: 2. 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: 3. 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. 4. Description of Device: 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. 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+ | HF120/60Hz<br>PowerPlus | 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 | | Power<br>requirement | 100-140VAC<br>or 200-260VAC,<br>50/60Hz | 100-260VAC,<br>50/60Hz | 110 or 220V,<br>50/60Hz | 110 or 220V,<br>50/60Hz | | User Interface | Exposure<br>Switch and<br>Console | Exposure Switch<br>and Console | Exposure<br>Switch and<br>Console | Exposure Switch<br>and Console | | Collimator | manual | manual | manual | manual | | Size | 9.5"x 8.75" x<br>16" | 16"x8.8"x9.5" | 13.4" x 9.9" x<br>9.8" | 13.4" x 7.6" x 6.4" | | Weight | 45.5lbs | 38.6lbs | 44lbs | 32lbs | 7. 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. {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ #### 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) 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." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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