(28 days)
No
The document describes a portable X-ray system and its components, focusing on hardware integration and standard compliance. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is described as a portable X-ray system for diagnostic imaging, which means it is used to obtain images for diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "may be used for handheld diagnostic imaging of body extremities" and "stand mounted diagnostic imaging of head, abdomen, or extremities," directly indicating its diagnostic purpose.
No
The device description explicitly states it is a "complete portable battery operated digital x-ray system" and lists multiple hardware components including a generator, wireless panel, and laptop computers.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states this is a "portable X-ray system" used for "diagnostic imaging of body extremities, head, abdomen, or extremities" and "imaging of the chest". This involves generating and capturing X-ray images of the inside of the body.
- No Mention of Biological Samples: The text does not mention the analysis of any biological samples.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
This is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities. The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid. - Not to be used on bariatric patients, unless imaging body extremities - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be reguired for full optimization of image quality and radiation exposure for different exam types.
Product codes (comma separated list FDA assigned to the subject device)
IZL, MQB
Device Description
This is a complete portable battery operated digital x-ray system with the indications for use stated above. It consists of the battery operator described in K182207 paired with the wireless battery operated digital x-ray acquisition components described in K191451. This is therefore a new combination of all previously cleared components. The digital x-ray receptor system uses a wireless panel and a Dell laptop computer fitted with a 300Mbps Mini Wireless N USB Adapter. The generator can be hand held (within the limitations of the indications), tripod mounted, or mobile stand mounted. Two models are proposed: IMPACT and X-RANGER. The two models differ in their targeted markets and in the type of computer supplied. The IMPACT uses a DELL PRECISION 3550 Laptop whereas the X-RANGER uses a DELL LATITUDE 7424 RUGGED LAPTOP. The IMPACT is aimed at the commercial market whereas the X-RANGER is aimed at the military market. The software is unmodified from that employed in our reference device (K191451) and it remains at a moderate level of concern. The image receptor (cleared under K191451) is wireless and measures 14x17 inches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Body extremities, head, abdomen, chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Software validation and risk analysis was performed. Laboratory testing was performed according to the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-54, IEC 62304, IEC 62366. The test results showed compliance with the above standards. Overall operation was confirmed by taking and reviewing test images using the imaging system and software from the reference device. Battery performance testing was conducted by a 30 Party Testing Lab according to United Nations "Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria", successfully performing Altitude simulation, Thermal test, Vibration, Shock, External short circuit, Impact, Overcharge, and Forced discharge tests. Battery life testing was performed to establish how many x-ray exposures can be made on one battery charge. Integration and usability testing were performed for the modified system (combination of predicate generator and reference imaging system) to confirm the ability of the user to assemble, operate, and get diagnostic images.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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March 19, 2021
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MinXray, Inc. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K210479
Trade/Device Name: IMPACT and X-Ranger Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB Dated: March 3, 2021 Received: March 9, 2021
Dear Mr. Kamm:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-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.
For
Thalia T. Mills, Ph.D. Director 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) K210479
Device Name IMPACT and X-Ranger
Indications for Use (Describe)
This is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities.
The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid.
-
Not to be used on bariatric patients, unless imaging body extremities
-
Not for mammography use
-
This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: 510(k) Number K210479 MinXray, Inc. 3611 Commercial Avenue Northbrook, Illinois 60062, USA Toll Free 1-800-221-2245 (USA & Canada) Tel. 1-847-564-0323 Fax 1-847-564-9040 Date Prepared: March 15, 2021 Contact: Keith Kretchmer, President
-
- Identification of the Device: Trade/Device Names: IMPACT and X-Ranger Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL, MQB Common/Usual Name: Mobile Diagnostic X-Ray System
-
- Equivalent legally marketed device: K182207 Trade/Device Name: TR90BH Manufacturer: MinXray, Inc. Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL Common/Usual Name: Mobile Diagnostic X-Ray System
-
- Reference device: The IMPACT and X-Ranger use the same digital receptor panel and software, unmodified, as found in: Trade/Device Name: CMDR 2CW Submission: K191451 Manufacturer: MinXray, Inc. Regulation Number: 21CFR892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB, and LLZ. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
-
- Indications for Use (intended use): This is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities. The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid. - Not to be used on bariatric patients, unless imaging body extremities
- Not for mammography use
- This device is not intended to replace a stationary radiographic system, which may be reguired for
4
full optimization of image quality and radiation exposure for different exam types.
-
- Description of the Device: This is a complete portable battery operated digital x-ray system with the indications for use stated above. It consists of the battery operator described in K182207 paired with the wireless battery operated digital x-ray acquisition components described in K191451. This is therefore a new combination of all previously cleared components. The digital x-ray receptor system uses a wireless panel and a Dell laptop computer fitted with a 300Mbps Mini Wireless N USB Adapter. The generator can be hand held (within the limitations of the indications), tripod mounted, or mobile stand mounted. Two models are proposed: IMPACT and X-RANGER. The two models differ in their targeted markets and in the type of computer supplied. The IMPACT uses a DELL PRECISION 3550 Laptop whereas the X-RANGER uses a DELL LATITUDE 7424 RUGGED LAPTOP. The IMPACT is aimed at the commercial market whereas the X-RANGER is aimed at the military market. The software is unmodified from that employed in our reference device (K191451) and it remains at a moderate level of concern. The image receptor (cleared under K191451) is wireless and measures 14x17 inches.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench testing indicates that the new device is as safe and effective as the predicate device. Proper system operation is fully verified upon installation.
| TR90BH K182207 | IMPACT AND X-RANGER | |||
|---|---|---|---|---|
| Intended | ||||
| Use: | The TR90BH is a portable X-ray system | |||
| with following limitations of use: The | ||||
| device may be used for handheld | ||||
| diagnostic imaging of body extremities. | ||||
| The device may be used for stand | ||||
| mounted diagnostic imaging of head, | ||||
| abdomen, or extremities. The device | ||||
| may be used for stand mounted imaging | ||||
| of the chest when used without a grid. - | ||||
| Not to be used on bariatric patients, | ||||
| unless imaging body extremities – Not | ||||
| for mammography use – The TR90BH is | ||||
| not intended to replace a stationary | ||||
| radiographic system, which may be | ||||
| required for full optimization of image | ||||
| quality and radiation exposure for | ||||
| different exam types. | The same, only the model number is changed. | |||
| This is a portable X-ray system with following | ||||
| limitations of use: The device may be used for | ||||
| handheld diagnostic imaging of body | ||||
| extremities. The device may be used for stand | ||||
| mounted diagnostic imaging of head, | ||||
| abdomen, or extremities. The device may be | ||||
| used for stand mounted imaging of the chest | ||||
| when used without a grid. |
- Not to be used on bariatric patients, unless
imaging body extremities - Not for mammography use
- This device is not intended to replace a
stationary radiographic system, which may be
required for full optimization of image quality
and radiation exposure for different exam
types. | | |
| Generator Characteristics | | | | |
| Weight: | 7.5kgs | SAME | | |
| Size / | 219 x 350 x 190 mm | SAME | | |
| Energy
Source: | Lithium-ion Rechargeable Battery
(57.6DC), 300 exposures per charge. | SAME | | |
7. Substantial Equivalence Chart: Below.
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| TR90BH K182207 | IMPACT AND X-RANGER | |
|---|---|---|
| Use | ||
| Interface: | Soft touch push buttons | SAME |
| Exposure | ||
| times: | 0.01 sec - 1.0 sec : 0.01 sec Step | |
| High Power Mode | ||
| 0.01 sec - 0.3 sec : 0.01 sec Step | SAME | |
| mA: | 20 mA @ 40 kVDC - 60 kVDC (2 kVP | |
| steps) | ||
| 15 mA @ 62 kVDC - 80 kVDC (2 kVP | ||
| steps) | ||
| 10 mA @ 82 kVDC - 90 kVDC (2 kVP | ||
| steps) | ||
| High Power Mode | ||
| 15 mA @ 82 kVDC - 90 kVDC (2 kVP | ||
| steps) | SAME | |
| Memory | ||
| settings | ||
| (technique) | 5 memories via pushbutton | SAME |
| HF Generator | High Frequency | SAME |
| kW | 1.35 kW | SAME |
| kVp: | 40 - 90kVp | SAME |
| X-ray Tube | D-0814 | SAME |
| FDA | ||
| Performance | ||
| Standard | Complies | SAME |
| Collimator | Mikasa BLD34L | SAME |
| Digital Image Capture | ||
| Panel | Not supplied | Same as used in our reference device |
| K191451, 14" x 17" Wireless | ||
| Pixel Pitch 154 μm | ||
| 2304 × 2816 pixels | ||
| Panel | ||
| Performance | Not supplied | Panel MTF ~63%..........(@ 1lp/mm) |
| Panel DQE~62%..........(@ 0lp/mm) | ||
| Software | Not supplied | Same as used in our reference device |
| K191451 |
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Image /page/6/Picture/0 description: The image shows two different setups of the TR90BH K182207 IMPACT AND X-RANGER. The left side of the image shows the TR90BH K182207 IMPACT AND X-RANGER by itself. The right side of the image shows the TR90BH K182207 IMPACT AND X-RANGER with the optional X200S Tripod, a laptop, and a carrying bag.
-
- Summary of non-clinical testing: The following testing still applies to our predicate generator since it has not been modified: Software validation and risk analysis was performed. Laboratory testing was performed according to the following standards:
IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) Medical Electrical Equipment, Part 1: General Requirements for Safety
- Summary of non-clinical testing: The following testing still applies to our predicate generator since it has not been modified: Software validation and risk analysis was performed. Laboratory testing was performed according to the following standards:
IEC 60601-1-2:2007 Medical Electrical Equipment-Part 1-2: General Requirements for Safety – 2. Collateral Standard-Electromagnetic compatibility - Requirements and tests
IEC 60601-1-3:2008 (Second Edition) for use with IEC 60601-1: 2005 (Third Edition) Medical electrical equipment Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment IEC 60601-1-6:2010 (Third Edition) for use in conjunction with IEC 60601-1: 2005 (Third Edition)Medical electrical equipment Part 1-6: General requirements for safety - Collateral Standard: Usability IEC 60601-2-28:2010 (Second Edition) for use in conjunction with IEC 60601-1: 2005 (Third edition) Medical electrical equipment Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
IEC 60601-2-54 (First Edition): 2009 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
IEC 62304:2006 (First Edition) Medical device software: Software life-cycle processes
IEC 62366: 2007 (First Edition) + A1: 2014 Medical devices – Application of usability engineering to medical devices.
The test results showed compliance with the above standards. We also confirmed overall operation by taking and reviewing test images using the imaging system and software from our reference device.
Previously performed: Battery performance testing: A 30 Party Testing Lab was engaged to do safety performance testing on the rechargeable lithium-ion battery pack, done according to the United Nations "Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria." The following testing was successfully performed: Altitude simulation, Thermal test, Vibration, Shock, External short circuit, Impact, Overcharge, and Forced discharge. In addition, battery life testing was performed to establish how many x-ray exposures can be made on one battery charge. The AC/DC adapter used with the battery charger is medical grade UL Listed (E356265).
7
During the original design process, we took the following FDA guidance into account: Guidance for Industry and FDA Staff Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use; Document issued on December 24, 2008. This involved employing extra shielding and precautionary information in the labeling.
For the modified system representing the combination of our predicate generator and our reference imaging system, we performed integration and usability testing to confirm the ability of the user to assemble, operate, and get diagnostic images using our reference digital imaging components. Assembly and system test procedures have been written and approved.
-
- Summary of clinical testing: Not applicable. Clinical testing was not deemed to show substantial equivalence. We relied on non-clinical testing and compliance with standards.
-
- Conclusion: After analyzing bench tests, it is the conclusion of MinXray Inc. that the IMPACT AND X-RANGER Portable X-Ray Equipment is as safe and effective as the predicate device, has few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.