(61 days)
Not Found
No
The summary describes a standard mobile X-ray device with basic features like technique presets and a user interface. There is no mention of AI, ML, or advanced image processing capabilities.
No
The device is described as a mobile X-ray device used for acquiring images, which is a diagnostic purpose, not a therapeutic one. It facilitates X-ray examinations to aid in diagnosis.
Yes
Explanation: The device description explicitly states, "JADE is a non-motorized mobile diagnostic xray device." Its purpose is to acquire X-ray images, which are used for diagnosis.
No
The device description explicitly lists hardware components such as a High-Frequency X-ray Generator, Collimator, and Exposure Hand Switch, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the JADE Mobile X-Ray device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Intended Use of JADE Mobile X-Ray: The intended use of the JADE Mobile X-Ray is to acquire X-ray images of a patient's anatomy. This is a form of in vivo (within the living body) imaging.
- Device Description: The description details a mobile X-ray machine that generates X-rays to create images of internal structures. This is consistent with an imaging device, not a device that analyzes biological samples.
Therefore, the JADE Mobile X-Ray falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The JADE Mobile X-Ray, is a mobile X-ray device, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography, bone density, or dedicated pediatric applications.
Product codes (comma separated list FDA assigned to the subject device)
IZL
Device Description
The JADE Mobile X-Ray, is a mobile x-ray device that comes in two models: JADE-32 (3.2kw max. output and JADE-40 (4kw max. output). JADE is a non-motorized mobile diagnostic xray device that can facilitate X-ray examinations, in situations where it is not possible or feasible to transport the patient to a ward with fixed equipment. The unit is stable and precise when using the optional Mobile or Portable Stand. The electric tube unit and wheel locks. column rotation, and a simple user interface to provide for added operator convenience and rapid patient positioning. X-Ray technique presets can be saved. The JADE Mobile X-Ray device can be used with a film screen cassette or a flat panel detector which are supplied by the user and are not part of the JADE Mobile X-Ray, device. The software used with the JADE Mobile system is new and is not based on the predicate device.
"Caution" The JADE Mobile X-ray should not be used as a handheld device.
The JADE device consists of:
- . High-Frequency X-ray Generator
- Collimator with 30 seconds LED lamp timer
- User Programmable APR
- . Exposure Hand Switch
- . Software(SDK, HT Frame and Membrane Console Firmware)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Desired parts of a patient's anatomy.
Indicated Patient Age Range
Patient
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)
Clinical testing is not necessary for the JADE Mobile system in order to demonstrate substantial equivalence to the predicate device.
Nonclinical Testing:
The complete system has been assessed and tested at the factory and by Standards testing facilities. The JADE Mobile X-Ray, device has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by JADE, and followed the process documented in the System Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
The main components of JADE Mobile X-ray, comply with the applicable regulatory requirements and design standards as follows:
- SAFETY
- IEC/EN 60601-1 3.1 Edition .
- . EN 60601-1:2006/A1:2013 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- EN 60601-1-3:2008/A1:2013. Medical electrical equipment -- Part 1-3: General . requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- . EN 60601-1-6:2010/A1:2015. Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- EN 60601-2-54:2009, Medical electrical equipment -- Part 2-54: Particular . requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- EN 60601-2-28:2010, Medical electrical equipment -- Part 2-28: Particular . requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- EMC
- EN60601-1-2:2015, Medical electrical equipment Part 1-2: General requirements for . safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- EN55011:2009/A1:2010, CISPR 11 :2009/A1:2010 ●
- EN 61000-3-2:2014, Electromagnetic compatibility (EMC) -- Part 3-2: Limits Limits Limits -● for harmonic current emissions (equipment input current
§ 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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Image /page/0/Picture/0 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
DRGEM Corporation % Mr. Carl Alletto Consultant OTech. Inc. 8317 Belew Drive MCKINNEY TEXAS 75071 February 5, 2019
Re: K183388
Trade/Device Name: JADE Mobile X-Ray Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: December 1, 2018 Received: December 14, 2018
Dear Mr. Alletto:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183388
Device Name JADE Mobile X-Ray
Indications for Use (Describe)
The JADE Mobile X-Ray, is a mobile X-ray device, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography, bone density, or dedicated pediations.
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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This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
510(k) number: K183388
Date Prepared:
December 1, 2018
Submitter's Information: 21 CFR 807.92(a)(1)
Mr. Ki-Nam YANG Director | QM representative DRGEM Corporation 7F E-B/D Gwangmyeong Techno-Park 60, Haan-ro, Gwangmyeong-si, Gyeonggi-do, 14322 Korea Email: radcheck@drgem.co.kr
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Product Name: | JADE Mobile X-Ray |
|---|---|
| Common Name: | Mobile X-Ray System |
| Classification: | System, X-Ray, Mobile |
| Regulation Number: | 892.1720 |
| Product Code: | IZL |
| Device Classification: | Class II |
Predicate Device: 21 CFR 807. 92(a)(3)
The JADE Mobile X-Ray, device is substantially equivalent to K182317:
| Device Classification Name | System, X-Ray, Mobile |
|---|---|
| 510(K) Number | K182317 |
| Device Name | AMADEO M-DR Mini, AMADEO M-AX Mini |
| Applicant | OEHM UND REHBEIN GMBH |
| Regulation Number | 892.1720 |
| Device Classification | Class II |
| Classification Product Code | IZL |
| Subsequent Product Code | MQB |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Radiology |
| 510k Review Panel | Radiology |
| Summary | Summary |
| Type | Traditional |
Device Description: 21 CFR 807 92(a)(4)
The JADE Mobile X-Ray, is a mobile x-ray device that comes in two models: JADE-32 (3.2kw max. output and JADE-40 (4kw max. output). JADE is a non-motorized mobile diagnostic xray device that can facilitate X-ray examinations, in situations where it is not possible or
4
feasible to transport the patient to a ward with fixed equipment. The unit is stable and precise when using the optional Mobile or Portable Stand. The electric tube unit and wheel locks. column rotation, and a simple user interface to provide for added operator convenience and rapid patient positioning. X-Ray technique presets can be saved. The JADE Mobile X-Ray device can be used with a film screen cassette or a flat panel detector which are supplied by the user and are not part of the JADE Mobile X-Ray, device. The software used with the JADE Mobile system is new and is not based on the predicate device.
"Caution" The JADE Mobile X-ray should not be used as a handheld device.
The JADE device consists of:
- . High-Frequency X-ray Generator
- Collimator with 30 seconds LED lamp timer
- User Programmable APR
- . Exposure Hand Switch
- . Software(SDK, HT Frame and Membrane Console Firmware)
| No. | PESS | Processor | Description |
|---|---|---|---|
| 1 | JADE | JADE_HTC | JADE_HTC at HT control board in x-ray generator controls whole x-ray generation |
| process by the control of System Control Module in CPC_SDK. This module | |||
| controls x-ray parameters such as kV, mA and exposure time, and controls the | |||
| filament and detector interfacing. | |||
| JADE_MCC | JADE_MCC at console board in control console consist of generator control | ||
| module. JADE_MCC display the state of X-ray parameter and generator. | |||
| 2 | CPC | CPC_SDK | CPC_SDK is the software provides user interface on generator control. CPC_SDK |
| consists of generator control Module and Display Module, System Diagnosis | |||
| Module |
- . Optional equipment:
- o Remote Controller (to control the Collimator Lamp, X-ray Exposure)
- Portable Stand o
- Mobile Stand O
Indications for Use: 21 CFR 807 92(a)(5)
The JADE Mobile X-Ray, is a mobile X-ray device, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography, bone density, or dedicated pediatric applications.
Technological Characteristics: 21 CFR 807 92(a)(6)
- . JADE Mobile X-ray specifications are in TABLE 1.
- TABLE 2 is the collimator specifications and
- TABLE 3, compares the predicate device and the new device. Any differences . between the predicate and the new device has no impact on safety or efficacy of the new device and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices.
TABLE 1 Mobile X-Ray Unit Specs
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| Model | JADE-32 | JADE-40 |
|---|---|---|
| Input Power | 100 - 240V~ (Free voltage input), | |
| 50/60Hz | 110 - 240V~ (Free voltage input), | |
| 50/60Hz | ||
| Output Rating | Max. 3.2 kW (40mA@80kV, | |
| 32mA@100kV, 25mA@120kV) | Max. 4 kW (50mA@80kV, | |
| 40mA@100kV, 32mA@120kV) | ||
| Type | Microprocessor controlled High Frequency inverter | |
| KV Range | 40 ~ 120 KV, 81Step (1KV Step) | |
| mA Range | 10 ~ 80 mA, 10Step (10, 12.5, 16, | |
| 20, 25, 32, 40, 50, 64, 80mA) | 10 ~ 100 mA, 11Step (10, 12.5, 16, | |
| 20, 25, 32, 40, 50, 64, 80, 100mA) | ||
| Exposure Time | 0.01 ~ 10 seconds, 21Step (in 25% Steps) | |
| mAs Range | 0.1 ~ 250 mAs, 35Step (in 25% Steps) | |
| X-ray Tube Type | Stationary Anode | |
| Focal Spot Size (Small / Large) | 0.5 / 1.5 mm | |
| Anode Heat Storage Capacity | 56,000HU (40,000 J) | |
| Power Cord Length | 5 m | |
| Exposure Hand-switch Cord Length | 5 m (Max. Length) | |
| X-ray switching frequency | 100 kHz | |
| Control | 2 Point Control (kV, mAs) | |
| Control Display | LED (7-seg display & indicators) | |
| Anatomical Programs | Preprogrammed 9 APR data - User Programmable | |
| External Interface | USB, Bluetooth (Option), DR Interface (Option) | |
| Max. Input Power | ||
| Rating | 25 A @ 240 V~, 35 A @ 100 V~ | 24 A @ 240 V~, 34 A @ 110 V~ |
| Weight | 16.8kg (37lb) (Including Collimator) |
TABLE 2 - Collimator Specs
| Model | KM1 |
|---|---|
| Manufacturer | DRGEM |
| Control | Manual with 15, 30, 45, 60sec. Lamp timer |
| Field Shape | Rectangular |
| Max. Field Size | 44x44cm (at 100cm SID) |
| Leakage Radiation |