APX-24 Portable X-ray System

K220678 · Aspenstate, Inc. · IZL · Mar 31, 2022 · Radiology

Device Facts

• Record ID: K220678
• Device Name: APX-24 Portable X-ray System
• Applicant: Aspenstate, Inc.
• Product Code: IZL · Radiology
• Decision Date: Mar 31, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The APX-24 Portable X-ray is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.

Device Story

Portable X-ray system; generates diagnostic X-ray images for adult and pediatric patients. Operates via high-frequency (102kHz) inverter; utilizes monoblock generator; controlled by dual-stage, deadman-type exposure switch. Used by physicians or technicians in clinical settings. Operator selects kVp and exposure time via pushbuttons; system uses software-based control with 2 CPUs to manage X-ray generation. Provides diagnostic images to assist healthcare providers in clinical decision-making; benefits patients by enabling portable, point-of-care diagnostic imaging.

Clinical Evidence

Bench testing only. Performance evaluation confirmed compliance with IEC 60601-1, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-2-65, and related electromagnetic compatibility and safety standards.

Technological Characteristics

Portable X-ray system; 120VAC/220-240VAC power; 102kHz high-frequency inverter; monoblock generator; Canon D-125SB X-ray tube; 1.2mm focal spot; 40-100kV range; 0.32-100mAs range; software-based control (2 CPUs); dual-stage deadman switch; continuously adjustable light beam collimator. Standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-2-65.

Indications for Use

Indicated for use by qualified/trained physicians or technicians on adult and pediatric subjects for diagnostic X-ray imaging.

Regulatory Classification

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

• MinXray HF100H+ (K052721)

Submission Summary (Full Text)

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March 31, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Aspenstate, Inc. % Mr. Dave Kim Regulatory Affairs Mtech Group 7505 Fannin St, Suite 610 HOUSTON TX 77054

Re: K220678

Trade/Device Name: APX-24 Portable X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: February 28, 2022 Received: March 8, 2022

## Dear Mr. Kim:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K220678

Device Name APX-24 Portable X-ray System

### Indications for Use (Describe)

The APX-24 Portable X-ray is intended for use by a qualified/trained physician on both adult and pediatric subjects for taking diagnostic X-rays.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block;">☑</div> |
|----------------------------------------------|--------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div style="display:inline-block;">☐</div> |

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## 510(k) Summary

This summary of 510(k) information is submitted following the requirements of 21 CFR Part 807.92.

| Date 510k summary prepared: | February 28, 2022 |
|-----------------------------|-------------------|
|-----------------------------|-------------------|

#### I. SUBMITTER

| Submitter's Name<br>Submitter's Address | Aspenstate, Inc<br>801 North Jupiter Rd, Suite 200<br>Plano TX 75074 |
|------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Submitter's Telephone<br>Contact person | Albert Kim/Managing Director<br>[e-mail]<br>Tel: [phone] |
| Official Correspondent<br>Address<br>Telephone | Dave Kim ([e-mail])<br>7505 Fannin St, Suite 610, Houston, TX 77054<br>[phone] |

#### II. DEVICE

| Trade/Device Name: | APX-24 Portable X-ray System |
|--------------------|----------------------------------------|
| Regulation Number: | 21 CFR 892.1720 |
| Regulation Name: | Mobile x-ray system |
| Regulatory Class: | II |
| Product Codes: | IZL |
| Common/Usual Name: | Digital Mobile Diagnostic X-Ray System |

#### III. PREDICATE DEVICE

| Trade/Device Name: |
|--------------------|
| 510(k) Number: |
| Regulation Number: |
| Regulation Name: |
| Regulatory Class: |
| Product Codes: |
| Common/Usual Name: |

MinXray HF100H+™ K052721 21 CFR 892.1720 Mobile x-ray system II IZL Digital Mobile Diagnostic X-Ray System

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#### DEVICE DESCRIPTION: IV.

The APX-24 Portable X-ray is a portable unit that operates from120 V / 220-240V, 50 / 60 Hz. The unit utilizes a newly designed high-frequency inverter and can bemounted to a tripod or support arm. The operator must observe the usual safety precautions regarding the use of x- rays.

#### V. Indications for Use: 21 CFR 807 92 (a) (5)

The APX-24 Portable X-ray is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.

| Characteristic | MinXray HF100H (K052721) | Aspenstate APX-24 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Intended for use by a<br>qualified/trained physician or<br>technician on both adult and<br>pediatric subjects for taking<br>diagnostic x-rays. | The APX-24 Portable X-ray is<br>intended for use by a<br>qualified/trained physician or<br>technician on both adult and<br>pediatric subjects for taking<br>diagnostic X-rays. |
| Size/weight | 406 x 222 x 241 mm18.6kgs | 414 x 230 x 215.5mm, 12.7kg |
| Energy Source | 100-140V 50-60 HzAC3 0kVA | 120VAC/220-240VAC, 50/60Hz |
| Mounting method | Unit is usually mounted to a<br>MinXray XGS MKIII Portable<br>Stand | This unit is not mounted to a<br>Portable Stand |
| User Interface | Up-Down pushbuttons for kVp<br>selections and exposure time<br>selections with LED indictors<br>and mAs indicators | Up/Down pushbuttons for kVp<br>selections and exposure time<br>selections with LED indicators |
| Exposure switch | Dual-stage, deadman type | Dual-stage, deadman type |
| Controls | Software-based, 2 CPUs. | Software-based, 2 CPUs. |
| Construction | Monobloc HF a generator,<br>Medical full-bridge inverter<br>system | Monoblock HF a generator, Medical<br>full-bridge inverter system |
| High Voltage<br>Energy Source | High frequency (60kHz)<br>inverter | High frequency (102kHz) inverter |
| Line Voltage<br>adjustment | Automatic, dynamic | Automatic, dynamic |
| | | |
| Exposure times | 0.03-0.2 sec(in 0.01 sec. Steps)<br>0.2-04 sec(in 0.02 sec. Steps)<br>0.4-1.0 sec(in 0.05 sec. Steps)<br>1.0-4.0 sec(m 0.1 sec. Steps) | 0.03-0.2 sec(in 0.01 sec. Steps)<br>0.2-04 sec(in 0.02 sec. Steps)<br>0.4-1.0 sec(in 0.05 sec. Steps)<br>1.0-4.0 sec(m 0.1 sec. Steps) |
| Tube potential(kV) | 40 - 100kV 2kVstep | 40-100kV (1kV step) |
| kV steps | 31(2kV-step) | 31(2kV-step) |
| Tube current(mA) | 30mA(40-60 kV)<br>25mA(62-80 kV)<br>20mA(82-100 kV) | 30 mA (40-50 kV)<br>30, 35, 40 mA (51-60 kV)<br>25, 30 mA (61-70 kV)<br>15, 20, 30 mA (71-80 kV)<br>13, 25 mA (81-90 kV)<br>10, 20 mA (91-100 kV) |
| mA steps | Constant | Constant |
| X-ray tube | Canon D-124S | Canon D-125SB |
| Anode heatStorage | 20,000HU | 50,000 HU |
| Focal SpotSize | 1.2 mm | 1.2 mm |
| mAs | 0.6-120mAs | 0.32-100mAs |
| Total filtration | 3.2mm AL equivalent | Min 2.8 mm AL |
| Collimator | Advantech R72<br>Continuously adjustable<br>light beam type with<br>central x-ray indicator | Continuously adjustable light beam type with central x-ray indicator |
| Source to Skin<br>Distance (SSD) | 300 mm | 300 mm |
| Performance<br>Standard | 21CFR 1020.30 | IEC60601-1-3, IEC60601-1-6,<br>IEC60601-2-28, IEC60601-2-54<br>21CFR 1020.30, 21CFR 1020.31 |
| Electrical safety | UL2601, IEC60601-1 | IEC60601-1 |

Technological characteristics: 21 CFR 807 92 (a) (6) Comparison Table

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### ASPENSTATE, INC

801 North JupiterRd, Suite 200, Plano, TX 70574 USA

Tel.: [phone]

#### VI. Discussion of differences

The subject device is similar to the predicate device regarding the indications for use and technological application. The subject and predicate devices are portable X-ray systems for taking diagnostic X-rays of human anatomy using a fixed tube current and voltage (kVp).

The differences are the device appearance, size, and user interface.

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ASPENSTATE, INC 801 North JupiterRd, Suite 200, Plano, TX 70574 USA Tel.: [phone]

#### VII. Nonclinical testing

Testing was performed successfully according to the following standards:

- > IEC 60601-1-3:2008+A1:2013
- > IEC 60601-2-65:2012
- > EN 60601-2-65:2013
- > EN 60601-1-2:2015
- > EN 61000-3-2:2014
- > EN 61000-3-3:2013
- > IEC 62133:2012
- > EN 62133:2013
- > EN 60601-1:2006/A1:2013
- > IEC 60601-2-54:2009 (First edition) + A1:2014 for use in conjunction with IEC 60601-1:2015 (third edition) + A1:2012

Furthermore, the following Specific Guidance Document was utilized in the device development to ensure the safety of this device for both the operators and patients: "The Content of Premarket Submissions for Software Contained in Medical Devices"

#### VIII. Conclusion:

By the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided above comparison table. the APX-24 Portable X-ray System has little difference with its size and user interface as the information in the table. However, the system is substantially equivalent to the predicate devices with its design, mechanical and electrical performance as described.

Performance evaluation (test) reports and the device inspection report confirmed that the APX-24 Portable X-ray System is suitable for the device's intended use.