← Product Code [IZL](/productcode/IZL) · K052341 # AJEX 9015/135H PORTABLE X-RAY (K052341) _Jpi America, Inc. · IZL · Oct 7, 2005 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K052341 ## Device Facts - **Applicant:** Jpi America, Inc. - **Product Code:** [IZL](/productcode/IZL.md) - **Decision Date:** Oct 7, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1720 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Pediatric ## Indications for Use The AJEX 9015/135H Portable X-rays are intended for use in mobile/portable applications, by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of body parts. -The AJEX 9015H is intended for use by foot and hand care clinics and portable orthopedic needs by sports medicine groups at sports arenas. -The AJEX 135H is intended for use in mobile applications for off-site patients that are not mobile. ## Device Story Portable X-ray units (AJEX 9015H, AJEX 135H) designed for diagnostic imaging in mobile/portable settings. Operator (physician, technician, or nurse) controls KvP via LED display and soft keys; preset memory keys store settings. Units can be hand-held, mounted on support arms, or mobile stands. Device generates X-ray exposures for body parts. Used in clinics, sports arenas, and off-site locations for non-mobile patients. Output is a radiographic image (captured by external receptor, not specified). Benefits include portability for point-of-care diagnostics. ## Clinical Evidence No clinical data provided; substantial equivalence is based on technological characteristics and design comparisons to predicate devices. ## Technological Characteristics Portable X-ray system; 110V 50/60 Hz power; LED display with KvP control and memory storage; manual 4-blade halogen collimator (50W or 100W); 1.2 mm focal spot. Dimensions vary by model (e.g., 23.8x34x19.4 cm for 9015H). System is mobile/portable. No software algorithm or connectivity specified. ## Regulatory 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. ## Predicate Devices - PXP 15/20/40 Portable X-ray units ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K 05234// # OCT 7 - 2005 EXHIBIT 4 (Page 1 of 2) 510 (k) Summary August 23, 2005 1. Submitter: | Company: | JPI America, Inc | |------------|-----------------------| | | 141-A Central Avenue | | | Farmingdale, NY 11735 | | Telephone: | 631-454-0090 | | Contact: | Abe Elgohary | 2. Identification of Device: Proprietary-Trade Name: Classification Name: Product Code: Common/Usual Name: AJEX 9015H and AJEX 135H Portable X-ray Units Mobile X-ray System 90 IZL Portable general Purpose X-ray Unit. #### 3. Equivalent Marketed Devise: This product is substantially equivalent to the PXP 15/20/40 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 9015H and AJEX 135H are portable x-ray units which operate at 110V 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. #### 5. Intended Use of AJEX 9015H AND AJEX 135H: The AJEX 9015/135H Portable X-rays are intended for use in mobile/portable applications, by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of body parts. -The AJEX 9015H is intended for use by foot and hand care clinics and portable orthopedic needs by sports medicine groups at sports arenas. -The AJEX 135H is intended for use in mobile applications for off-site patients that are not mobile. . . . {1}------------------------------------------------ ## EXHIBIT 4 (Page 2 of 2) 510 (k) Summary - 6. Substantial Equivalence Chart ### Model AJEX-9015H AND AJEX-135H | Characteristics | PXP-HF15 | PXP-HF20 | PXP-HF40 | AJEX- 9015H | AJEX-135H | |----------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | Intended use. | Portable
general
radiographic
applications | SAME | SAME | SAME | SAME | | MA | 15 | 20 | 35 | 15 | 35 | | kVp | 80 | 90 | 100 | 90 | 100 | | Max. output | 1.2kW | 1.35kW | 2.4kW | 1.35kW | 2.25kW | | Focal Spot | 1.2 mm | 1.2 mm | 1.2 mm | 1.2 mm | 1.2 mm | | Power
requirement | 120/220
Vol.,
50/60 Hz | 120/220
Vol.,
50/60 Hz | 120/220 Vol.,
50/60 Hz | 110 Vol.,
50/60 Hz | 110 Vol.,
50/60 Hz | | User Interface | LED
display.
Up-Down
push
buttons for
kVp
selection.
With
memory
key storage. | LED display.
Up-Down
push buttons
for kVp
selection.
With
memory key
storage. | LED display.
Up-Down
push buttons
for kVp
selection.
With memory
key storage. | LED
display. Up-
Down push
buttons for
kVp
selection.
With
memory key
storage. | LED
display. Up-
Down push
buttons for
kVp
selection.
With
memory key
storage. | | Collimator | Manual
50W
Halogen
4 Blade | Manual
50W
Halogen
4 Blade | Manual
150W
Halogen
4 Blade | Manual
50W
Halogen
4 Blade | Manual
100W
Halogen
4 Blade | | Size | 20.32
x22.86x17.
78 cm | 20x32x30
cm | 25x20x35cm | 23.8x34x19.4
cm | 16.5x29x21.5
cm | | Weight | 22 Ib | 21 Ib | 28 Ib | 17 Ib | 32 Ib | #### 7. Conclusion: After analyzing all the data it is the conclusion of JPI that the AJEX-9015H and 135H 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}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wings, representing health, human services, and well-being. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Abe Elgohary Vice President JPI America, Inc. 141-A Central Avenue FARMINGDALE NY 11735 Re: K052341 Trade/Device Name: AJEX 9015.135H Portable X-Ray Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: August 23, 2005 Received: August 26, 2005 Dear Mr. Elgohary: 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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. OCT 7 - 2005 {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K052341 Device Name: AJEX 9015/135H PORTABLE X-RAY Indications for Use: The AJEX 9015/135H Portable X-rays are intended for use in general radiographic medical applications, by qualified/trained doctors or technicians on Tactographic incored. applications, and ing diagnostic radiographic exposures of body parts. -The AJEX 9015H is used by foot and hand care clinics and portable orthopedic needs by sports medicine groups at sports arenas for general radiographic exposures. -The AJEX 135H is used in general radiographic mobile applications with stand, by qualified/trained doctors, technicians or nurses, for on -site and off-site patients that are not mobile . Prescription Use __ X ============================================================================================================================================================================ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _N/A_____________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Swanson Page _1_ of _1_ ** --- **Source:** [https://fda.innolitics.com/device/K052341](https://fda.innolitics.com/device/K052341) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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