(56 days)
No
The summary describes a standard digital radiography system and does not mention any AI or ML capabilities, image processing features, or provide details about training or test sets typically associated with AI/ML models.
No
The device is described as taking "diagnostic radiographic exposures," indicating its purpose is for diagnosis, not therapy.
Yes
The Intended Use section clearly states that the device is "Intended for use...for taking diagnostic radiographic exposures." This indicates its purpose is to aid in diagnosis.
No
The device description explicitly states it is comprised of hardware components including a High Voltage Generator, Digital Detector, and Digital Radiography Operator Console, in addition to software.
No, 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 provided description clearly states that this device is a Digital Radiography System that takes radiographic exposures (X-rays) of various body parts. This is an imaging modality that works externally to the body, not by analyzing samples taken from the body.
- Intended Use: The intended use is for taking diagnostic radiographic exposures, which is a form of medical imaging, not in vitro testing.
The information provided describes a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
Intended for use by a qualified/trained doctor or technician on adult subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
Product codes
IZL, MQB
Device Description
The Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is comprised of a High Voltage Generator with a maximum power output of 63kW, the Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60C, MobileApex 60H) can meet different exposure needs for varying positions and body mass. With the Digital Radiography System's (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) state-of-the-art design and powerful 63kW generator coupled with the Digital Detector (CareView 1500Cwe, CareView 750Cw, Mars1717X, Mars1417X, Luna 1012X) and Digital Radiography Operator Console, users can obtain clear images quickly and easily.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts.
Indicated Patient Age Range
adult subjects
Intended User / Care Setting
qualified/trained doctor or technician / Medical Facilities and/or Universities
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
Non-clinical performance tests were conducted covering electrical safety and electromagnetic compatibility (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54). Compliance with FDA EPRC Performance Standard: 21CFR 1020.30 and 21CFR 1020.31 was also tested. Software validation and verification testing was performed according to IEC 62304. Usability was assessed according to IEC 62366-1. The results of these nonclinical tests indicate that the device is as safe and effective as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K201932, K210316, K210314, K163019, K221345, K161459, K130883, K143232
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.
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March 28, 2024
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.
Shenzhen Browiner Tech Co., Ltd % Long Yang COO, Shenzhen Hlongmed Biotech Company 16th Floor, Tianming Technology Building, No.8 Wushitou Road Songpingshan Community, Xili Street, Nanshan District, SHENZHEN, GD 518052 CHINA
Re: K240284
Trade/Device Name: Digital Radiography System (MobileApex 60E, MobileApex 60G, MobileApex 60H) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL, MQB Dated: January 31, 2024 Received: February 1, 2024
Dear Long Yang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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for
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Gabriela M. Digitally signed by Gabriela M. Rodal -S Rodal -S Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K240284
Device Name
Digital Radiography System (MobileApex 60E, MobileApex 60G, MobileApex 60G, MobileApex 60H)
Indications for Use (Describe)
Intended for use by a qualified/trained doctor or technician on adult subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
| 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) |
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510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(K) number is: K240284 -Date of Summary: March 27, 2024
1. Submitter
Shenzhen Browiner Tech Co., Ltd.
Room 501, Building C, Ganghongji High-Tech Intelligent Industrial Park, No.1008, Songbai Road, Yangguang Community, Xili Street, Nanshan District, 518055 Shenzhen, PEOPLE'S REPUBLIC OF CHINA
2. Contact Person
2.1 Primary Contact Person
Long Yang (COO)
Shenzhen Hlongmed Biotech Company
16th floor, Tianming Technology Building, No.8 Wushitou Road, Songpingshan Community,
Xili Street, Nanshan District, Shenzhen, P.R.C
Tel: 0086-755-86664986
Fax: 0086-755-86664933
E-mail: yanglong@hlongmed.com
2.2 Secondary Contact Person
Li Chen(RA engineer)
Shenzhen Browiner Tech Co., Ltd.
Room 501, Building C, Ganghongji High-Tech Intelligent Industrial Park, No.1008, Songbai Road, Yangguang Community, Xili Street, Nanshan District, 518055 Shenzhen, PEOPLE'S
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REPUBLIC OF CHINA
Tel: 0086-15752770581
Fax: 0086-755-22674695
E-mail: lichen@browiner.com
- Date Prepared: March 27, 2024
4. Proposed Device Information
Trade name: Digital Radiography System (MobileApex 60E, MobileApex 60F,
MobileApex 60G, MobileApex 60H)
Model: MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H
Common name: Digital Radiography System
Classification name: Mobile X-ray System
Review Panel: Radiology
Product Code:Primary Product Code: IZL; Secondary Product Code: MQB Regulation
Class: II
Regulation Number: 21 CFR 892.1720
| 5. Predicate Device Information | |
|---|---|
| -- | --------------------------------- |
| Manufacturer | Proprietary /Trade Name | 510(K) Number |
|---|---|---|
| Huestis | Machine | |
| MX40 Mobile Digital X-ray System | K181874 | |
| Corporation |
6. Device Description
The Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is comprised of a High Voltage Generator with a maximum power output of 63kW, the Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60C, MobileApex 60H) can meet different exposure needs for varying positions and body mass. With
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the Digital Radiography System's (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) state-of-the-art design and powerful 63kW generator coupled with the Digital Detector (CareView 1500Cwe, CareView 750Cw, Mars1717X, Mars1417X, Luna 1012X) and Digital Radiography Operator Console, users can obtain clear images quickly and easily.
7. Intended use
Intended for use by a qualified/trained doctor or technician on adult subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
8. Comparison to Predicate Device
The Digital Radiography System have the similar intended use, similar technological characteristics as the following predicate device. Subject Device is substantially equivalent in its technologies and functionality to the MX40 Mobile Digital X-ray System manufactured by Huestis Machine Corporation that is already cleared under premarketed notification number K181874.
The details of the Technological Characteristics of Device as to Compare to the Predicate Device can are as below.
| Item | Proposed Device | Predicate Device | |
|---|---|---|---|
| Device Name | Digital Radiography System | MX40 Mobile Digital X-ray System | |
| Model | MobileApex 60E | ||
| MobileApex 60F | |||
| MobileApex 60G | |||
| MobileApex 60H | MX40 | ||
| 510(k) number | / | K181874 | |
| Submitter | Shenzhen Browiner Tech Co., Ltd | Huestis Machine Corporation | |
| Intended use | Intended for use by a qualified/trained | ||
| doctor or technician on adult subjects for | Intended for use by a qualified/trained | ||
| doctor or technician on both adult and | |||
| Item | Proposed Device | Predicate Device | |
| taking diagnostic radiographic exposures of | |||
| the skull, spinal column, chest, abdomen, | |||
| extremities, and other body parts. | |||
| Applications can be performed with the | |||
| patient sitting, standing, or lying in the | |||
| prone or supine position. Not for | |||
| mammography. | pediatric subjects for taking diagnostic | ||
| radiographic exposures of the skull, spinal | |||
| column, chest, abdomen, extremities, and | |||
| other body parts. Applications can be | |||
| performed with the patient sitting, standing, | |||
| or lying in the prone or supine position. Not | |||
| for mammography. | |||
| General Information | |||
| Modes of | |||
| Operation | Manual | Manual | |
| Classification | |||
| Name | Mobile X-ray System | Mobile X-ray System | |
| Classification | |||
| Panel | Radiology | Radiology | |
| Classification | |||
| Regulation | 21 CFR 892.§1720 | 21 CFR 892.§1720 | |
| Product Code | IZL | IZL | |
| Subsequent | |||
| Product Code | MQB | MQB | |
| Medical Device | |||
| Class | Class II | Class II | |
| Performance | |||
| Standard | 21CFR1020.30 | 21CFR1020.30 | |
| Configuration | Mobile Battery or Line Operated | Mobile Battery or Line Operated | |
| Power Source | Single Phase Line, 100V-240V~, ±10% | Single Phase Line Regulation from 100 - | |
| 240 Vac (+/-10%) | |||
| Electrical | |||
| Safety and | |||
| EMC | IEC 60601-1 and IEC 60601-1-2 | IEC 60601-1 and IEC 60601-1-2 | |
| Standards | |||
| (Other than | |||
| Electrical and | |||
| EMC) | WiFi 802.11a/b/g/n/ac and: FCC Rules and | ||
| Regulations | Wi-Fi 802.11b/g and: FCC Rules and | ||
| Regulations | |||
| Item | Proposed Device | Predicate Device | |
| Generator | |||
| Type | BWG-50-500D, manufactured by Shenzhen Browiner | Shenzhen Browiner | |
| Generator | |||
| Power Level | Nominal Power: 63 kW (630 mA, 100 kV, 100 ms) | ||
| Maximum Power: 63 kW (630 mA, 100 kV) | 50 KW | ||
| kV Range | 40 - 150 kV, in 1 kV steps, ±10% | 40 - 150 KV | |
| mA Range | 10 - 630 mA, ±20% | ||
| Contain the following mA slot: | |||
| 10, 11, 12.5, 14, 16, 18, 20, 22, 25, 28, 32, | |||
| 36, 40, 45, 50, 56, 63, 71, 80, 90, 100, 110, | |||
| 125, 140, 160, 180, 200, 220, 250, 280, 320, | |||
| 360, 400, 450, 500, 560, 630 | 10 - 630 mA | ||
| Exposure Time | |||
| Range | 1 - 10000 ms, ± (10%+1 ms) | ||
| Contain the following time slot: | |||
| 1.0, 1.1, 1.25, 1.4, 1.6, 1.8, 2.0, 2.2, 2.5, 2.8, | |||
| 3.2, 3.6, 4.0, 4.5, 5.0, 5.6, 6.3, 7.1, 8.0, 9.0, | |||
| 10, 11, 12.5, 14, 16, 18, 20, 22, 25, 28, 32, | |||
| 36, 40, 45, 50, 56, 63, 71, 80, 90, 100, 110, | |||
| 125, 140, 160, 180, 200, 220, 250, 280, 320, | |||
| 360, 400, 450, 500, 560, 630, 710, 800, 900, | |||
| 1000, 1100, 1250, 1400, 1600, 1800, 2000, | |||
| 2200, 2500, 2800, 3200, 3600, 4000, 4500, | |||
| 5000, 5600, 6300, 7100, 8000, 9000, 10000 | 0.001 - 6.3 sec | ||
| mAs Range | 0.1 - 630 mAs, ± (10 % + 0.2 mAs) | ||
| Contain the following mAs slot: | |||
| 0.1, 0.11, 0.125, 0.14, 0.16, 0.18, 0.2, 0.22, | |||
| 0.25, 0.28, 0.32, 0.36, 0.4, 0.45, 0.5, 0.56, | |||
| 0.63, 0.71, 0.8, 0.9, 1.0, 1.1, 1.25, 1.4, 1.6, | |||
| 1.8, 2.0, 2.2, 2.5, 2.8, 3.2, 3.6, 4.0, 4.5, 5.0, | |||
| 5.6, 6.3, 7.1, 8.0, 9.0, 10, 11, 12.5, 14, 16, | |||
| 18, 20, 22, 25, 28, 32, 36, 40, 45, 50, 56, 63, | |||
| 71, 80, 90, 100, 110, 125, 140, 160, 180, | |||
| 200, 220, 250, 280, 320, 360, 400, 450, 500, | 0.1 - 320 mAs | ||
| Item | Proposed Device | Predicate Device | |
| 560, 630 | |||
| X-Ray Tube | |||
| Type | Siemens SDR-150/30/50 | ||
| Canon E7252X | Toshiba E7843X | ||
| Material | Rhenium-Tungsten Molybdenum | Rhenium-Tungsten Molybdenum | |
| Max Voltage | 150 kV | 150 kVp | |
| Nominal Focal | |||
| Spot | SDR-150/30/50: 0.6/1.0 | ||
| E7252X: 0.6/1.2 | 0.6/1.2 | ||
| Anode type | Rotating | Rotating | |
| Nominal Anode | |||
| Input Power | SDR-150/30/50: | ||
| Small focus 43kW @ 180Hz | |||
| Large Focus 81kW @ 180Hz | |||
| E7252X: | |||
| Small focus 27kW @ 180Hz | |||
| Large Focus 75kW @ 180Hz | Large Focus 50kW @ 6Hz | ||
| Small focus 22kW @ 60Hz | |||
| Imaging Panel | |||
| Image | |||
| acquisition | |||
| panels (Both | |||
| systems | |||
| use already | |||
| cleared digital | |||
| panels) | CareView 1500Cwe (K201932) | ||
| Pixels size: 140 μm | |||
| 3072×2560 pixels | |||
| Mars1417X (K210316) | |||
| Pixels size: 100 μm | |||
| 4300×3500 pixels | |||
| Mars1717X (K210314) | |||
| Pixels size: 100 μm | |||
| 4267×4267 pixels | |||
| CareView 750Cw (K163019) | |||
| Pixels size: 120 μm | |||
| 2560×2048 pixels | |||
| Luna 1012X (K221345) | |||
| Pixels size: 100 μm | |||
| 3152×2502 pixels | Varian 4336R | ||
| PAXSCAN 4336W | |||
| Pixel Size 144 μm/3072 x 2560 pixels | |||
| (previously cleared as part of K161459, | |||
| 09/06/2016) | |||
| Item | Proposed Device | Predicate Device | |
| System Software | Image acquisition and control Software | MOC (V05) | ECOM Digital Radiography Operator Console |
| (Acquisition Software and Graphical Interface-previously cleared as part of K130883 (04/18/13) and K143232 (01/30/15)) | |||
| Operating System | Windows OS | Windows OS | |
| Environment of use | Medical Facilities and/or Universities | Medical Facilities and/or Universities | |
| Collimator | Model | BRC-60, manufactured by Shenzhen Browiner | Shenzhen Browiner Tech Co., Ltd Or Huestis 150MC |
| Operation | Manual, square/rectangular field, field indicator lamp | Manual, square/rectangular field, field indicator lamp | |
| Anatomical Programs | 500+ Anatomical settings | 500+ Anatomical settings | |
| External Connectivity | Connection | Wi-Fi and Ethernet Cable | Wi-Fi and Ethernet Cable |
| DICOM | YES | YES | |
| Wi-Fi Communication with detectors | Wireless | Wireless | |
| Standard | Applied standard | IEC60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance | |
| IEC60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral | IEC60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance | ||
| IEC60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral | |||
| Item | Proposed Device | Predicate Device | |
| standard: Electromagnetic compatibility - | |||
| Requirements and tests. | standard: Electromagnetic compatibility - | ||
| Requirements and tests. | |||
| IEC60601-1-3 Medical electrical equipment | |||
| Part 1-3: General requirements for basic | |||
| safety and essential performance – | IEC60601-1-3 Medical electrical equipment | ||
| Part 1-3: General requirements for basic | |||
| safety and essential performance – | |||
| Collateral standard: Radiation protection in | |||
| diagnostic X-Ray equipment | Collateral standard: Radiation protection in | ||
| diagnostic X-Ray equipment | |||
| IEC60601-2-54 Medical electrical | |||
| equipment Part 2-54: Particular | |||
| requirements for the basic safety and | |||
| essential performance of X-Ray equipment | |||
| for radiography and radioscopy | IEC60601-2-54 Medical electrical | ||
| equipment Part 2-54: Particular | |||
| requirements for the basic safety and | |||
| essential performance of X-Ray equipment | |||
| for radiography and radioscopy | |||
| IEC62304 Medical device software – | |||
| Software life-cycle processes | IEC62304 Medical device software – | ||
| Software life-cycle processes | |||
| 21CFR 1020.30 Diagnostic X-Ray systems | |||
| and their major components | 21CFR 1020.30 Diagnostic X-Ray systems | ||
| and their major components | |||
| 21CFR 1020.31 Radiographic equipment | 21CFR 1020.31 Radiographic equipment |
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9. Summary of non-clinical performance Tests
Digital Radiography System has been tested for electrical safety and electromagnetic compatibility (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54). The device also complies with FDA EPRC Performance Standard: 21CFR 1020.30 and 21CFR 1020.31. The software validation and verification testing was also performed and meets the requirements of IEC 62304. Usability was conducted according to IEC 62366-1. The results of nonclinical testing indicate that the Digital Radiography System is as safe and effective as the predicate device.
The Digital Radiography System has been tested to be in compliance with the following standards:
• IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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· IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
• IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential
performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
• IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and
essential performance of X-ray equipment for radiography and radioscopy
• IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION
Medical device software - Software life cycle processes
• IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION
Medical devices - Part 1: Application of usability engineering to medical devices
- · 21CFR 1020.30 Diagnostic X-Ray systems and their major components
- · 21CFR 1020.31 Radiographic equipment
10. Substantial Equivalent Conclusions
Digital Radiography System has the similar intended use, similar technological characteristics as the predicate device. Moreover, non-clinical testing contained in this submission demonstrated that any difference in their technological characteristics does not raise any new issues of safety and effectiveness.
In conclusion, Digital Radiography System is substantial equivalent to the predicate device.