(23 days)
Not Found
No
The summary describes a standard portable X-ray unit and does not mention any AI/ML capabilities, image processing, or related performance metrics.
No
The device is described as taking "diagnostic X-rays," indicating it is used for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is "for taking diagnostic X-rays," directly indicating its diagnostic purpose.
No
The device description explicitly states it is a "portable unit that operates from 120 V / 220-240V, 50 / 60 Hz" and "utilizes a newly designed high-frequency inverter," indicating it is a hardware device. The performance studies also reference standards related to electrical and X-ray equipment, further confirming it is not software-only.
No, the APX-24 Portable X-ray is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue, etc.
- The APX-24 Portable X-ray is used to take diagnostic X-rays of the human body directly. It uses radiation to create images, not to analyze biological samples.
The description clearly states its purpose is for "taking diagnostic X-rays" of "adult and pediatric subjects," which is a direct imaging modality, not an in vitro test.
N/A
Intended Use / Indications for Use
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.
Product codes
IZL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained physician or technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Nonclinical testing was performed successfully according to 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. Additionally, "The Content of Premarket Submissions for Software Contained in Medical Devices" guidance document was utilized. 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
Submitter's Address | Aspenstate, Inc
801 North Jupiter Rd, Suite 200
Plano TX 75074 |
|------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Submitter's Telephone
Contact person | Albert Kim/Managing Director
albert.kim@aspenstate.com
Tel: +1- 214-257-0113 |
| Official Correspondent
Address
Telephone | Dave Kim (davekim@mtech-inc.net)
7505 Fannin St, Suite 610, Houston, TX 77054
+713-467-2607 |
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
4
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 | |
| qualified/trained physician or | ||
| technician on both adult and | ||
| pediatric subjects for taking | ||
| diagnostic x-rays. | 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. | ||
| 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 | |
| MinXray XGS MKIII Portable | ||
| Stand | This unit is not mounted to a | |
| Portable Stand | ||
| User Interface | Up-Down pushbuttons for kVp | |
| selections and exposure time | ||
| selections with LED indictors | ||
| and mAs indicators | Up/Down pushbuttons for kVp | |
| selections and exposure time | ||
| 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, | |
| Medical full-bridge inverter | ||
| system | Monoblock HF a generator, Medical | |
| full-bridge inverter system | ||
| High Voltage | ||
| Energy Source | High frequency (60kHz) | |
| inverter | High frequency (102kHz) inverter | |
| Line Voltage | ||
| adjustment | Automatic, dynamic | Automatic, dynamic |
| Exposure times | 0.03-0.2 sec(in 0.01 sec. Steps) | |
| 0.2-04 sec(in 0.02 sec. Steps) | ||
| 0.4-1.0 sec(in 0.05 sec. Steps) | ||
| 1.0-4.0 sec(m 0.1 sec. Steps) | 0.03-0.2 sec(in 0.01 sec. Steps) | |
| 0.2-04 sec(in 0.02 sec. Steps) | ||
| 0.4-1.0 sec(in 0.05 sec. Steps) | ||
| 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) | |
| 25mA(62-80 kV) | ||
| 20mA(82-100 kV) | 30 mA (40-50 kV) | |
| 30, 35, 40 mA (51-60 kV) | ||
| 25, 30 mA (61-70 kV) | ||
| 15, 20, 30 mA (71-80 kV) | ||
| 13, 25 mA (81-90 kV) | ||
| 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 | |
| Continuously adjustable | ||
| light beam type with | ||
| central x-ray indicator | Continuously adjustable light beam type with central x-ray indicator | |
| Source to Skin | ||
| Distance (SSD) | 300 mm | 300 mm |
| Performance | ||
| Standard | 21CFR 1020.30 | IEC60601-1-3, IEC60601-1-6, |
| IEC60601-2-28, IEC60601-2-54 | ||
| 21CFR 1020.30, 21CFR 1020.31 | ||
| Electrical safety | UL2601, IEC60601-1 | IEC60601-1 |
Technological characteristics: 21 CFR 807 92 (a) (6) Comparison Table
5
ASPENSTATE, INC
801 North JupiterRd, Suite 200, Plano, TX 70574 USA
Tel.: +214-257-0113
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.
6
ASPENSTATE, INC 801 North JupiterRd, Suite 200, Plano, TX 70574 USA Tel.: +214-257-0113
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.