(64 days)
Not Found
No
The description focuses on the hardware and basic control mechanisms of the X-ray system, with no mention of AI or ML for image processing, analysis, or system control. The "processed images" likely refers to standard digital image processing techniques, not AI/ML.
No
The device is explicitly described as a "diagnostic X-ray system," intended for "producing diagnostic X-ray images," and used for "dental examination (teeth and jaw)" to help the clinician "examine the parts with processed images." Its purpose is to aid in diagnosis, not to provide therapy.
Yes
The device description explicitly states, "The Portable X-ray System (Models: MINIX-V, MINIX-S) is a diagnostic x-ray system, which is intended to be used by trained dentists or dental technicians." It is also intended to produce "diagnostic X-ray images."
No
The device description clearly outlines numerous hardware components including an x-ray generating part, x-ray tube, device controller, power controller, user interface, beam limiting part, backscatter shield, remote control switch, battery pack, inverter, and electrical protective devices. While it mentions processing images, the core function and components are hardware-based for generating X-rays.
Based on the provided information, 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: This device is an X-ray system that generates radiation to create images of the teeth and jaw within the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for producing diagnostic X-ray images using intra-oral image receptors. This is an imaging modality, not an in vitro test.
- Device Description: The description details the generation and application of X-rays to the patient's anatomy, not the analysis of biological samples.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic X-ray images using intra-oral image receptors. Its use is intended for both adults and pediatric subjects.
Product codes
EHD
Device Description
The portable x-ray system (Models: MINIX-V, MINIX-S) is an x-ray generating device which is mainly designed for dental examination (teeth and jaw).
Operating principle is that the high voltage electricity is getting into x-ray tube and generates x-ray source. This x-ray source comes out from the emitting cone and penetrates teeth and jaw, and makes x-ray images through image receptors (chemical film or digital sensor). Once the power is supplied from the rechargeable lithium-ion polymer battery pack, the inverter generates high frequency and high voltage. Boosted and rectified DC high voltage (MINIX-V: 70kV, MINIX-S: 60kV) is loaded onto the x-ray tube, and the tube generates x-ray.
Micro control unit (MCU) and other control parts function to display data on LCD and control the system by the input information from user interface. When operator controlled (fixed amount of) x-ray is exposed to patient's teeth and jaw, clinician can examine the parts with processed images from intra-oral image receptors (analog film, digital phosphor plate or digital sensor).
The Portable X-ray System (Models: MINIX-V, MINIX-S) is composed of an x-ray generating part with an x-ray tube, a device controller (Control PCB), a power controller (Power PCB), an user interface (LCD window), a beam limiting part (x-ray emitting cone), a backscatter shield, and a remote control switch (hand-switch).
The Portable X-ray System (Models: MINIX-V, MINIX-S) is a diagnostic x-ray system, which is intended to be used by trained dentists or dental technicians. Its use is intended for both adult and pediatric subjects. This device includes a high frequency inverter that changes direct current to alternating current, x-ray tube, electrical protective devices, and other elements. The system with high frequency x-ray provides sharp and clear images, and the total lead protection seal protects patients and dentists from leakage or scattered radiation from the device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Dental (teeth and jaw)
Indicated Patient Age Range
both adults and pediatric subjects
Intended User / Care Setting
trained dentists and dental technicians
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)
Performance evaluation (test) reports and device inspection report confirmed that the Portable X-ray System (Model: MINIX-V, MINIX-S) is suitable for its intended use and user instruction of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
December 3, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Digimed Co., Ltd. (Digimed Corporation until Dec. 31, 2012) % Mr. Yong Park President Innoden LLC. 212 Wells Avenue, S# 102 RENTON WA 98057
Re: K152859
Trade/Device Name: Portable X-ray System (Model: MINIX-V / MINIX-S ) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: September 30, 2015 Received: September 30, 2015
Dear Mr. Park:
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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
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 Industry and Consumer Education 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,
Robert Oels
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152859
Device Name Portable X-ray System (Models: MINIX-V, MINIX-S)
Indications for Use (Describe) The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic X-ray images using intra-oral image receptors. Its use is intended for both adults and pediatric subjects.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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 Health (CDRH) (Signature)
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."
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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3
510(k) Summary of Portable X-ray System (MINIX-V&MINIX-S)
| Date Prepared: | Sep. 16, 2015 |
|---|---|
| Company Name: | DIGIMED CO., LTD. |
| (DIGIMED CORPORATION. until Dec. 31, 2012) | |
| Address: | 309~311, 318-ho, |
| 145, Gasan digital 1-ro, Geumcheon-gu, | |
| Seoul, 153-787 Korea | |
| Telephone number: | +82-2-2624-1551 |
| Fax: | +82-2-2624-1553 |
| E-mail: | kwon@digimed.co.kr |
| Contact: | Youngbae Kwon, Managing Director |
1. Company and Correspondent Making the Submission:
2. US Agent for FDA Contact:
| Name | Mr. Yong Park |
|---|---|
| Company Name: | INNODEN LLC. |
| Address: | 212 Wells Ave. S #102, |
| Renton, WA 98057 | |
| Telephone number: | 425-572-0283 |
| Fax: | 425-988-1256 |
| E-mail: | drpark@innoden.com |
3. Device Information:
| Proprietary-Trade Name: | Portable X-Ray System (Models: MINIX-V, MINIX-S) |
|---|---|
| Classification Name: | Extra-oral Source X-Ray System: EHD, Class II per |
| regulation 21CFR 872.1800 | |
| Common/Usual Name: | Portable X-Ray System |
4. Predicate Devices:
| Manufacturer: | GENORAY | DIGIMED |
|---|---|---|
| Device: | Portable X-Ray System | |
| (Model: PORT-X II) | Portable X-Ray System | |
| (Model: BIOX, | ||
| PROX/DIOX-602) | ||
| Classification: | Extra-oral Source X-Ray System: EHD, Class II per regulation 21CFR 872.1800 | Extra-oral Source X-Ray System: EHD, Class II per regulation 21CFR 872.1800 |
| 510(k) Number: | K063121 | |
| (Decision Date: Jan. 11, 2007) | K103600 - BIOX | |
| (Decision Date: Mar. 10, 2011) | ||
| K082167 - PROX / DIOX-602 | ||
| (Decision Date: July 29, 2008) |
4
5. Indications for Use (Intended Use):
The Portable X-ray System (Models: MINIX-V, MINIX-S) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors. Its use is intended for both adult and pediatric subjects.
Compatible intra-oral image receptors are described as below.
-
- Analog dental x-ray films
-
- CCD and CMOS digital sensors
-
- Digital phosphor plates
-
- Most of the intra-oral image receptors which intended for dental x-ray examination
6. Description of Device
The portable x-ray system (Models: MINIX-V, MINIX-S) is an x-ray generating device which is mainly designed for dental examination (teeth and jaw).
Operating principle is that the high voltage electricity is getting into x-ray tube and generates x-ray source. This x-ray source comes out from the emitting cone and penetrates teeth and jaw, and makes x-ray images through image receptors (chemical film or digital sensor). Once the power is supplied from the rechargeable lithium-ion polymer battery pack, the inverter generates high frequency and high voltage. Boosted and rectified DC high voltage (MINIX-V: 70kV, MINIX-S: 60kV) is loaded onto the x-ray tube, and the tube generates x-ray.
Micro control unit (MCU) and other control parts function to display data on LCD and control the system by the input information from user interface. When operator controlled (fixed amount of) x-ray is exposed to patient's teeth and jaw, clinician can examine the parts with processed images from intra-oral image receptors (analog film, digital phosphor plate or digital sensor).
The Portable X-ray System (Models: MINIX-V, MINIX-S) is composed of an x-ray generating part with an x-ray tube, a device controller (Control PCB), a power controller (Power PCB), an user interface (LCD window), a beam limiting part (x-ray emitting cone), a backscatter shield, and a remote control switch (hand-switch).
The Portable X-ray System (Models: MINIX-V, MINIX-S) is a diagnostic x-ray system, which is intended to be used by trained dentists or dental technicians. Its use is intended for both adult and pediatric subjects. This device includes a high frequency inverter that changes direct current to alternating current, x-ray tube, electrical protective devices, and other elements. The system with high frequency x-ray provides sharp and clear images, and the total lead protection seal protects patients and dentists from leakage or scattered radiation from the device.
5
7. Safety and Effectiveness. Comparison to Predicate Device:
Safety and effectiveness of the subject device is considered with the latest version of test regulations. The subject device was shown to provide an equivalent level of safety and performance as compared to the predicate devices.
"Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices"
8. Safety, EMC and Performance Data:
The subject device complies with the safety and performance standards listed in the chart below. Test reports were provided to demonstrate conformance. All required documents and reports are submitted to the appropriate oversight agency to establish compliance with the applicable requirements.
9. The differences between the subject device and the predicate devices
The subject device has little differences with its design, size, and user interface compare to the predicate devices. Detailed differences can be identified from "Substantial Equivalence Chart".
6
10. Substantial Equivalence Chart
| GENORAY | DIGIMED | DIGIMED | ||||
|---|---|---|---|---|---|---|
| FEATURE | PORT-X II | MINIX-V | MINIX-S | |||
| (K063121) | (NEW) | (NEW) | ||||
| INTENDED USE | All three systems are intended as extraoral x-ray sources to be used with intraoral image receptors | |||||
| for diagnostic imaging by dentists or dental technicians. | ||||||
| MECHANICAL | ||||||
| Size | 7.8" x 5.8" x 3.7" | 4.8" x 8.7" x 5.3" | 4.8" x 8.7" x 5.3" | |||
| Source to | ||||||
| skin distance | 10 cm | 20 cm | 20 cm | |||
| Cone diameter | 7 cm | 5.5 cm | 5.5 cm | |||
| User interface | Up-down buttons for exposure | |||||
| time selection with timer | ||||||
| display. Additionally, several | ||||||
| user-selectable preset times | ||||||
| with patient size and tooth | ||||||
| selection icons on an LCD | ||||||
| display | Up-down buttons for exposure | |||||
| time selection with timer | ||||||
| display. Additionally, several | ||||||
| user-selectable preset times | ||||||
| with patient size, image- | ||||||
| receptor type, and tooth | ||||||
| selection icons on an LCD | ||||||
| display | Up-down buttons for exposure | |||||
| time selection with timer | ||||||
| display. Additionally, several | ||||||
| user-selectable preset times | ||||||
| with patient size, image- | ||||||
| receptor type, and tooth | ||||||
| selection icons on an LCD | ||||||
| display | ||||||
| Backscatter | ||||||
| radiation protection | None | 6.3" dia. Pb-filled acrylic | ||||
| plastic scatter shield | 6.3" dia. Pb-filled acrylic | |||||
| plastic scatter shield | ||||||
| Exposure switch | Exposure button at x-ray | |||||
| control panel | Exposure button at front cover | |||||
| on right hand side, | ||||||
| or a remote control switch | Exposure button at front cover | |||||
| on right hand side, | ||||||
| or a remote control switch | ||||||
| Tubehead mounting | Handheld, or on a tripod | Handheld, on optional arms or | ||||
| on a tripod | Handheld, on optional arms or | |||||
| on a tripod | ||||||
| Half-value layer | (not available) | 2.3 mm Al | 2.0 mm Al | |||
| ELECTRICAL | ||||||
| Energy source | Rechargeable 22.2 V DC | |||||
| Lithium Polymer battery pack | Rechargeable 22.2 V DC | |||||
| Lithium Polymer battery pack | Rechargeable 22.2 V DC | |||||
| Lithium Polymer battery pack | ||||||
| Exposure time | 0.01~2.0 seconds in 46 steps | 0.01~2.0 seconds in 0.01 | ||||
| increments | 0.01~2.0 seconds in 0.01 | |||||
| increments | ||||||
| Time Accuracy | ± (10% +1 ms) | ± (10% +1 ms) | ± (10% +1 ms) | |||
| mA | 2 mA fixed | 2 mA fixed | 2 mA fixed | |||
| kVp | 60 kV fixed | 70 kV fixed | 60 kV fixed | |||
| Waveform | Constant Potential (DC) | Constant Potential (DC) | Constant Potential (DC) | |||
| Duty Cycle | (not available) | 1:60 | 1:60 | |||
| EMI standards | EN60601-1-2 | EN60601-1-2, IEC60601-1-2 | ||||
| CISPR 11, IEC61000-3-2 | ||||||
| IEC61000-3-3 | EN60601-1-2, IEC60601-1-2 | |||||
| CISPR 11, IEC61000-3-2 | ||||||
| IEC61000-3-3 | ||||||
| X-RAY PERFORMANCE | ||||||
| Performance | ||||||
| standards | EN 60601-1 | |||||
| EN 60601-1-3 | ||||||
| EN 60601-2-7 | ||||||
| EN 60601-2-28 | ||||||
| EN 60601-2-32 | IEC 60601-1 | |||||
| IEC 60601-1-3 | ||||||
| IEC 60601-2-65 | IEC 60601-1 | |||||
| IEC 60601-1-3 | ||||||
| IEC 60601-2-65 | ||||||
| Difference | SSD, Cone diameter, Backscatter radiation protection, Exposure switch, kV (MiniX-V only) |
- Predicate device (Model: PORT-X II) from GENORAY
7
| 2) Predicate device (Model: PROX/DIOX-602) from DIGIMED | |||
|---|---|---|---|
| FEATURE | DIGIMED | ||
| PROX/DIOX-602 | |||
| (K082167) | DIGIMED | ||
| MINIX-V | |||
| (NEW) | DIGIMED | ||
| MINIX-S | |||
| (NEW) | |||
| INTENDED USE | All three systems are intended as extraoral x-ray sources to be used with intraoral image receptors | ||
| for diagnostic imaging by dentists or dental technicians. | |||
| MECHANICAL | |||
| Size | PROX: 7" x 9.3" x 5.4" | ||
| DIOX-602: 5.3" x 9.4" x 6.9" | 4.8" x 8.7" x 5.3" | 4.8" x 8.7" x 5.3" | |
| Source to | |||
| skin distance | 20 cm | 20 cm | 20 cm |
| Cone diameter | 6 cm | 5.5 cm | 5.5 cm |
| User interface | Up-down buttons for exposure | ||
| time selection with timer | |||
| display. Anatomical tooth | |||
| buttons, patient size change | |||
| button, and image receptor | |||
| type change button. Each | |||
| button shows icons on an LCD | |||
| display. Several user-selectable | |||
| preset times. | Up-down buttons for exposure | ||
| time selection with timer | |||
| display. Additionally, several | |||
| user-selectable preset times | |||
| with patient size, image- | |||
| receptor type, and tooth | |||
| selection icons on an LCD | |||
| display | Up-down buttons for exposure | ||
| time selection with timer | |||
| display. Additionally, several | |||
| user-selectable preset times | |||
| with patient size, image- | |||
| receptor type, and tooth | |||
| selection icons on an LCD | |||
| display | |||
| Backscatter | |||
| radiation protection | 6.3" dia. Pb-filled acrylic | ||
| plastic scatter shield | 6.3" dia. Pb-filled acrylic | ||
| plastic scatter shield | 6.3" dia. Pb-filled acrylic | ||
| plastic scatter shield | |||
| Exposure switch | Exposure button at front cover | ||
| on right hand side, | |||
| or a remote control switch | Exposure button at front cover | ||
| on right hand side, | |||
| or a remote control switch | Exposure button at front cover | ||
| on right hand side, | |||
| or a remote control switch | |||
| Tubehead mounting | Handheld, on optional arms or | ||
| on a tripod | Handheld, on optional arms or | ||
| on a tripod | Handheld, on optional arms or | ||
| on a tripod | |||
| Half-value layer | 2.0 mm Al | 2.3 mm Al | 2.0 mm Al |
| ELECTRICAL | |||
| Energy source | Rechargeable 24 V DC | ||
| Lithium Polymer battery pack | Rechargeable 22.2 V DC | ||
| Lithium Polymer battery pack | Rechargeable 22.2 V DC | ||
| Lithium Polymer battery pack | |||
| Exposure time | 0.01~1.6 seconds in 0.01 | ||
| increments | 0.01~2.0 seconds in 0.01 | ||
| increments | 0.01~2.0 seconds in 0.01 | ||
| increments | |||
| Time Accuracy | $\pm$ (10% +1 ms) | $\pm$ (10% +1 ms) | $\pm$ (10% +1 ms) |
| mA | 2 mA fixed | 2 mA fixed | 2 mA fixed |
| kVp | 60 kV fixed | 70 kV fixed | 60 kV fixed |
| Waveform | Constant Potential (DC) | Constant Potential (DC) | Constant Potential (DC) |
| Duty Cycle | 1:60 | 1:60 | 1:60 |
| EMI standards | EN60601-1-2, IEC60601-1-2 | ||
| CISPR 11, IEC61000-3-2 | |||
| IEC61000-3-3 | EN60601-1-2, IEC60601-1-2 | ||
| CISPR 11, IEC61000-3-2 | |||
| IEC61000-3-3 | EN60601-1-2, IEC60601-1-2 | ||
| CISPR 11, IEC61000-3-2 | |||
| IEC61000-3-3 | |||
| X-RAY PERFORMANCE | |||
| Performance | |||
| standards | EN 60601-1 | ||
| EN 60601-1-3 | |||
| EN 60601-2-7 | |||
| EN 60601-2-28 | |||
| EN 60601-2-32 | IEC 60601-1 | ||
| IEC 60601-1-3 | |||
| IEC 60601-2-65 | IEC 60601-1 | ||
| IEC 60601-1-3 | |||
| IEC 60601-2-65 | |||
| Difference | Cone diameter, Energy source, Exposure time, kV (MiniX-V only) | ||
| 3) Predicate device (Model: BIOX) from DIGIMED | |||
| FEATURE | DIGIMED | ||
| BIOX | |||
| (K103600) | DIGIMED | ||
| MINIX-V | |||
| (NEW) | DIGIMED | ||
| MINIX-S | |||
| (NEW) | |||
| INTENDED USE | All three systems are intended as extraoral x-ray sources to be used with intraoral image receptors | ||
| for diagnostic imaging by dentists or dental technicians. | |||
| MECHANICAL | |||
| Size | 7.6" x 9.3" x 5.4" | 4.8" x 8.7" x 5.3" | 4.8" x 8.7" x 5.3" |
| Source to | |||
| skin distance | 21 cm | 20 cm | 20 cm |
| Cone diameter | 6 cm | 5.5 cm | 5.5 cm |
| User interface | Up-down buttons for exposure | ||
| time selection with timer | |||
| display. Anatomical tooth | |||
| buttons, patient size change | |||
| button, and image receptor | |||
| type change button. Each | |||
| button shows icons on an LCD | |||
| display. Several user-selectable | |||
| preset times. | Up-down buttons for exposure | ||
| time selection with timer | |||
| display. Additionally, several | |||
| user-selectable preset times | |||
| with patient size, image- | |||
| receptor type, and tooth | |||
| selection icons on an LCD | |||
| display | Up-down buttons for exposure | ||
| time selection with timer | |||
| display. Additionally, several | |||
| user-selectable preset times | |||
| with patient size, image- | |||
| receptor type, and tooth | |||
| selection icons on an LCD | |||
| display | |||
| Backscatter | |||
| radiation protection | 6.3" dia. Pb-filled acrylic | ||
| plastic scatter shield | 6.3" dia. Pb-filled acrylic | ||
| plastic scatter shield | 6.3" dia. Pb-filled acrylic | ||
| plastic scatter shield | |||
| Exposure switch | Exposure button at front cover | ||
| on right hand side, | |||
| or a remote control switch | Exposure button at front cover | ||
| on right hand side, | |||
| or a remote control switch | Exposure button at front cover | ||
| on right hand side, | |||
| or a remote control switch | |||
| Tubehead mounting | Handheld, on optional arms or | ||
| on a tripod | Handheld, on optional arms or | ||
| on a tripod | Handheld, on optional arms or | ||
| on a tripod | |||
| Half-value layer | 2.0 mm Al | 2.3 mm Al | 2.0 mm Al |
| ELECTRICAL | |||
| Energy source | Rechargeable 24 V DC | ||
| Lithium Polymer battery pack | Rechargeable 22.2 V DC | ||
| Lithium Polymer battery pack | Rechargeable 22.2 V DC | ||
| Lithium Polymer battery pack | |||
| Exposure time | 0.01~1.6 seconds in 0.01 | ||
| increments | 0.01~2.0 seconds in 0.01 | ||
| increments | 0.01~2.0 seconds in 0.01 | ||
| increments | |||
| Time Accuracy | $\pm$ (10% +1 ms) | $\pm$ (10% +1 ms) | $\pm$ (10% +1 ms) |
| mA | 3 mA fixed | 2 mA fixed | 2 mA fixed |
| kVp | 60 kV fixed | 70 kV fixed | 60 kV fixed |
| Waveform | Constant Potential (DC) | Constant Potential (DC) | Constant Potential (DC) |
| Duty Cycle | 1:60 | 1:60 | 1:60 |
| EMI standards | EN60601-1-2, IEC60601-1-2 | ||
| CISPR 11, EN61000-3-2, | |||
| EN61000-3-3 | EN60601-1-2, IEC60601-1-2 | ||
| CISPR 11, IEC61000-3-2 | |||
| IEC61000-3-3 | EN60601-1-2, IEC60601-1-2 | ||
| CISPR 11, IEC61000-3-2 | |||
| IEC61000-3-3 | |||
| X-RAY PERFORMANCE | |||
| Performance | |||
| standards | EN 60601-1 | ||
| EN 60601-1-3 | |||
| EN 60601-2-7 | |||
| EN 60601-2-28 | |||
| EN 60601-2-32 | IEC 60601-1 | ||
| IEC 60601-1-3 | |||
| IEC 60601-2-65 | IEC 60601-1 | ||
| IEC 60601-1-3 | |||
| IEC 60601-2-65 | |||
| Difference | SSD, Cone diameter, Energy source, Exposure time, mA (BIOX), kV (MiniX-V only) |
8
3) Predicate device (Model: BIOX) from DIGIMED
9
11. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided above comparison table, the Portable X-ray System (Models: MINIX-V, MINIX-S) has little difference with its size and user interface as the information in the table. But the system is substantially equivalent to the predicate devices with its design, mechanical and electrical performance as described.
Performance evaluation (test) reports and device inspection report confirmed that the Portable X-ray System (Model: MINIX-V, MINIX-S) is suitable for its intended use and user instruction of the device.