(28 days)
The Wireless/Wired DR-ID 1200SDK System is intended to capture for display radiographic images of human anatomy . It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The DR-ID 1200SDK System is not intended for mammography, fluoroscopy, tomography, and angiography applications.
The subject device DR-ID 1200SDK is a detector/software system, previously cleared as a component of the predicate FDR D-EVO II (K142003). The x-ray generator, necessary for a fullyoperational radiographic system, is not part of the subject device is designed as an alternative system added in FDR D-EVO II Flat Panel Detector System (DR-ID 1200) made by FUJIFILM. The subject device does not include imaging processing unit FDX Console (DR-ID 300CL) but the function of console is combined by system integrators. Both the subject device and predicate device are indicated for general purpose radiography. The software package is unchanged from the predicate, however the SW name was changed from DR-ID 1200MC (K142003) to DR-ID 1200SDK.
The document provided is a 510(k) premarket notification for a medical device called the DR-ID 1200SDK System. This notification aims to demonstrate "substantial equivalence" to a predicate device, the FDR D-EVO II Flat Panel Detector System (DR-ID 1200).
Crucially, this document states "No clinical study has been performed." Therefore, there is no acceptance criteria or study data that proves the device meets acceptance criteria in the traditional sense of a clinical performance study with human subjects.
Instead, the submission relies on non-clinical performance data and a comparison of technological characteristics to demonstrate substantial equivalence to a previously cleared device.
Here's an breakdown based on your request, even though a clinical study report is not available:
1. Table of acceptance criteria and the reported device performance
Since no clinical study was performed, there are no specific clinical acceptance criteria or reported device performance metrics in the context of diagnostic accuracy (e.g., sensitivity, specificity) for human interpretation. The "performance" data refers to compliance with established non-clinical standards and the device's physical/technical specifications being "Same" as the predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Non-Clinical / Comparison) |
|---|---|
| Non-Clinical Standards Compliance: | |
| AAMI/ANSI ES60601-1 (Electrical Safety) | Conforms to AAMI/ANSI ES60601-1 |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Conforms to IEC 60601-1-2 |
| IEC 62304 (Software Life Cycle Processes) | Conforms to IEC 62304 |
| IEC 62366-1 (Usability Engineering) | Conforms to IEC 62366-1 |
| FDA Guidance: Solid State X-ray Imaging Devices | Followed to describe detector characteristics |
| Risk Analysis & V&V: | Satisfactory results |
| Necessary Verification and Validation activities | |
| Technological Characteristics (all "Same" as Predicate): | |
| - Indications for Use | Same |
| - Scintillator | Same |
| - X-ray Conversion | Same |
| - Unique Detector Characteristic (ISS) | Same |
| - Detector Cord (Wired/Wireless) | Same |
| - Detector Weight | Same |
| - Withstand Load | Same |
| - Exposure size/Active Area (inch/cm) | Same |
| - Number of Pixels | Same |
| - Dimensions (Detector exterior) | Same |
| - Pixel Size | Same |
| - Acquisition Bit Depth | Same |
| - DQE (RQA5, lp/mm) | Same (with reported percentage and tolerance) |
| - MTF (RQA5, lp/mm) | Same (with reported percentage and tolerance) |
| - Detector tiling | Same |
| - Method of Detector Cooling | Same |
| - Operating Temperature | Same |
| - Auto X-ray Detection Feature | Same |
| - Wireless Specifications | Same |
| - Security feature | Same |
| - Battery Specifications | Same |
| - Additional Components for Wireless feature | Same |
| - Waterproof level | Same |
| - Antimicrobial coating | Same |
| - Image compression | Same |
| - Grids (Optional) | Same |
Differences from Predicate (and rationale for substantial equivalence):
- Removal of imaging processing unit FDX Console (DR-ID 300CL), optional Docking Stand (DR-ID 1200DS), and optional Fujifilm Access Point: These are considered minor modifications that "do not affect the indications for use, the fundamental scientific technology, safety and effectiveness, and image quality." The device is intended to be integrated with system integrators' consoles.
- Removal of memory exposure mode: This function allows storing images in the detector memory without an immediate connection to the processing unit. The document states "Even if this function is not supported, images can be sent to the image processing unit; thus the change does not affect the indications for use."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No clinical test set was used.
- The "performance data" refers to non-clinical tests based on regulatory standards. The provenance of such testing data (location, retrospective/prospective) is not specified but would typically be internal testing by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical test set with ground truth established by experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring expert adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. This device is a digital X-ray detector system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is hardware (detector) and associated software for image acquisition, not an AI algorithm for standalone diagnosis or detection.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth was established as no clinical study was performed. The "ground truth" for the non-clinical tests would be the established engineering and physics standards for detector performance.
8. The sample size for the training set
- Not applicable. This device is a digital X-ray detector system, not an AI algorithm that requires a training set in the AI/ML sense.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
FUJIFILM Corporation % Mrs. Kamila Sak Regulatory Affairs Specialist FUJIFILM Medical Systems U.S.A. Inc. 81 Hartwell Avenue, Suite 300 LEXINGTON MA 02421
April 10, 2020
Re: K200668
Trade/Device Name: DR-ID 1200SDK System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: March 12, 2020 Received: March 13, 2020
Dear Mrs. Kamila Sak:
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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)
Device Name DR-ID 1200SDK System
Indications for Use (Describe)
The Wireless/Wired DR-ID 1200SDK System is intended to capture for display radiographic images of human anatomy . It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The DR-ID 1200SDK System is not intended for mammography, fluoroscopy, tomography, and angiography applications.
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 K200668
Date Prepared: April 02, 2020
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928
Contact Person:
Kamila Sak Specialist, Regulatory Affairs Telephone: (347) 577-2309 Email: kamila.sak@fujifilm.com
Device Name and Classification:
| Product Name: | DR-ID 1200SDK System |
|---|---|
| Model Number: | DR-ID 1200 |
| Regulation Description: | Stationary x-ray system |
| Regulation Medical Specialty: | Radiology |
| CFR Section: | 21 CFR 892.1680 |
| Device Class: | Class II |
| Product Code: | MQB |
Predicate Device:
| Product Name: | FDR D-EVO II Flat Panel Detector System |
|---|---|
| Model Number: | DR-ID 1200 |
| Regulation Description: | Stationary x-ray system |
| Regulation Medical Specialty: | Radiology |
| CFR Section: | 21 CFR 892.1680 |
| Device Class: | Class II |
| Product Code: | MQB |
The subject device DR-ID 1200SDK System is a variation of the legally marketed FDR D-EVO II Flat Panel Detector System (DR-ID 1200). The predicate device FDR D-EVO II had received 510(k) clearance via K142003 on October 21, 2014, and was documented internally several times after that.
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The Wireless/Wired DR-ID 1200SDK System is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The DR-ID 1200SDK System is not intended for mammography, fluoroscopy, tomography, and angiography applications.
Description of the Device:
The subject device DR-ID 1200SDK is a detector/software system, previously cleared as a component of the predicate FDR D-EVO II (K142003). The x-ray generator, necessary for a fullyoperational radiographic system, is not part of the subject device is designed as an alternative system added in FDR D-EVO II Flat Panel Detector System (DR-ID 1200) made by FUJIFILM. The subject device does not include imaging processing unit FDX Console (DR-ID 300CL) but the function of console is combined by system integrators. Both the subject device and predicate device are indicated for general purpose radiography. The software package is unchanged from the predicate, however the SW name was changed from DR-ID 1200MC (K142003) to DR-ID 1200SDK.
Performance Data:
Non-clinical Performance Data: DR-ID 1200SDK conforms to the following standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 62304 and IEC 62366-1. In addition, the FDA's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (September 1, 2016) was followed to describe the detector characteristics.
As required by the risk analysis, necessary verification and validation activities were performed including software testing, and the results were satisfactory.
Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
Comparison of Technological Characteristics:
The proposed device DR-ID 1200SDK differs from the predicate device in the following minor modifications:
- Removal of imaging processing unit FDX Console (DR-ID 300CL), optional Docking Stand (DR-ID 1200DS), and optional Fujifilm Access Point
- Removal of memory exposure mode
Substantial Equivalence:
The company's DR-ID 1200SDK System (DR-ID 1200) has the same intended use and indications for use as the previously cleared predicate D-EVO II Flat Panel Detector System (DR-ID 1200) cleared under K142003. The differences described below do not affect the indications for use, the fundamental scientific technology, safety and effectiveness, and image Special 510(k): DR-ID 1200SDK System (DR-ID 1200) 6-2
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Image /page/5/Picture/0 description: The image shows the Fujifilm logo. The logo is in black, except for a small red square above the second 'I' in Fujifilm. The logo is simple and modern, and it is easily recognizable.
quality.
The subject device DR-ID 1200SDK system does not include imaging processing unit FDX Console (DR-ID 300CL), Docking stand, and Fujifilm access point. Docking stand and Fujifilm access point are optional components and do not affect the Indications for Use. DR-ID 1200SDK system can be connected to the console made by system integrators. The DR-ID 1200SDK system itself does not have a user interface, but when combined with console, it has almost the same functions and performance as the predicate device.
The subject device DR-ID 1200SDK system does not support the memory exposure mode. The memory exposure mode is a function for capturing an image with the flat panel detector alone without image processing unit, storing the image in the flat panel detector memory, and transmitting the image to the image processing unit later. Even if this function is not supported, images can be sent to the image processing unit; thus the change does not affect the indications for use.
Therefore, the subject device DR-ID 1200SDK System (DR-ID 1200) can be considered to be substantially equivalent to the predicate device FDR D-EVO II Flat Panel Detector System (DR-ID 1200).
Comparison of Technological Characteristics:
A comparison of the technological characteristics between the subject device and predicate device is provided below:
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| Subject DeviceDR-ID 1200SDK system | Predicate DeviceK142003, cleared Oct. 21, 2014FDR D-EVO II | Comment forsafety andperformance | ||
|---|---|---|---|---|
| Indications for Use | The Wireless/Wired DR-ID 1200SDK system isintended to capture for display radiographic images ofhuman anatomy. It is intended for use in generalprojection radiographic applications includingpediatric and neonatal exams wherever conventionalfilm/screen or CR systems may be used. The DR-ID1200SDK System is not intended for mammography,fluoroscopy, tomography, and angiographyapplications. | The Wireless/Wired FDR D-EVO II flat paneldetector system is intended to capture for displayradiographic images of human anatomy. It isintended for use in general projection radiographicapplications including pediatric and neonatal examswherever conventional film/screen or CR systemsmay be used. The FDR D-EVO II is not intended formammography, fluoroscopy, tomography, andangiography applications. | Same as thepredicate deviceexcept the devicename | |
| Detector Characteristics | ||||
| Appearance | Image: DR-ID 1200SDK system appearance | Image: FDR D-EVO II appearance | Same | |
| Scintillator | DR-ID1201SE, DR-ID1202SE Gd2O2S:Tb (GOS)DR-ID1211SE, DR-ID1212SE, DR-ID1213SE CsI:TI(CsI) | DR-ID1201SE, DR-ID1202SE Gd2O2S:Tb (GOS)DR-ID1211SE, DR-ID1212SE, DR-ID1213SE CsI:TI(CsI) | Same | |
| X-rayConversion | Indirect conversion (a-Si) | Indirect conversion (a-Si) | Same | |
| Unique DetectorCharacteristic | ISS (irradiation side sampling): captures image fromfront of detector, reducing blur, resulting in anincrease in sharpness and DQE | ISS (irradiation side sampling): captures image fromfront of detector, reducing blur, resulting in anincrease in sharpness and DQE | Same | |
| Detector Cord | Wired / Wireless | Wired / Wireless | Same | |
| Detector Weight(with battery) | DR-ID1201SE : Approx.5.7 lbs (2.5kg)DR-ID1211SE : Approx.5.8 lbs (2.6kg)DR-ID1202SE, DR-ID1212SE : Approx.7.1 lbs (3.2kg)DR-ID1213SE : Approx.3.3 lbs (1.5kg) | DR-ID1201SE : Approx.5.7 lbs (2.5kg)DR-ID1211SE : Approx.5.8 lbs (2.6kg)DR-ID1202SE, DR-ID1212SE : Approx.7.1 lbs (3.2kg)DR-ID1213SE : Approx.3.3 lbs (1.5kg) | Same | |
| Withstand Load | Point load: 1600N (160kg or 352.7 lbs) / ø40mm(1.6in.)Surface load: 3100N (310kg or 683.4 lbs) | Point load: 1600N (160kg or 352.7 lbs) / ø40mm(1.6in.)Surface load: 3100N (310kg or 683.4 lbs) | Same | |
| CR/DRIntegration | N/A | FDX Workstation capable of simultaneous connectionto Fujifilm CR and FDR D-EVO II | FDX Workstationis not included inthe subjectdevice. | |
| Exposuresize/Active Area(inch) | DR-ID1201SE, DR-ID1211SE :13.8x16.8DR-ID1202SE, DR-ID1212SE :16.7x16.8DR-ID1213SE : 9.07x11.3 | DR-ID1201SE, DR-ID1211SE : 13.8x16.8DR-ID1202SE, DR-ID1212SE : 16.7x16.8DR-ID1213SE: 9.07x11.3 | Same | |
| Exposuresize/Active Area(cm) | DR-ID1201SE, DR-ID1211SE :35.04x42.54DR-ID1202SE, DR-ID1212SE : 42.48x35.05DR-ID1213SE: 23.04x28.80 | DR-ID1201SE, DR-ID1211SE :35.04x42.54DR-ID1202SE, DR-ID1212SE:42.48x35.05DR-ID1213SE: 23.04x28.80 | Same | |
| Number of Pixels | DR-ID1201SE, DR-ID1211SE :2336x2836DR-ID1202SE, DR-ID1212SE :2832x2836DR-ID1213SE: 1536x1920 | DR-ID1201SE, DR-ID1211SE:2336x2836DR-ID1202SE, DR-ID1212SE:2832x2836DR-ID1213SE: 1536x1920 | Same | |
| Dimensions(Detectorexterior) | DR-ID1201SE, DR-ID1211SE:38.4cm(W) x 46.0cm(D) x 1.5cm(H)DR-ID1202SE, DR-ID1212SE :46.0cm(W) x 46.0cm(D) x 1.5cm(H)DR-ID1213SE:26.8cm(W) x 32.8cm(D) x 1.5cm(H) | DR-ID1201SE, DR-ID1211SE:38.4cm(W) x 46.0cm(D) x 1.5cm(H)DR-ID1202SE, DR-ID1212SE :46.0cm(W) x 46.0cm(D) x 1.5cm(H)DR-ID1213SE:26.8cm(W) x 32.8cm(D) x 1.5cm(H) | Same | |
| Pixel Size | 150 μm | 150 μm | Same | |
| AcquisitionBit Depth | 16 bit | 16 bit | Same | |
| DQE (RQA5,lp/mm) detector alone,without tabletop | 1- | DR-ID1201SE,DR-ID1202SE31%Measurement tolerance (±10%)DR-ID1211SE,DR-ID1212SE,DR-ID1213SE54%Measurement tolerance (±10%) | DR-ID1201SE,DR-ID1202SE31%Measurement tolerance (±10%)DR-ID1211SE,DR-ID1212SE,DR-ID1213SE54%Measurement tolerance (±10%) | Same |
| MTF (RQA5,lp/mm) | 2 | DR-ID1201SE,DR-ID1202SE42%(High mode)Measurement tolerance (±10%)DR-ID1211SE,DR-ID1212SE,DR-ID1213SE54%(High mode)Measurement tolerance (±10%) | DR-ID1201SE,DR-ID1202SE42%(High mode)Measurement tolerance (±10%)DR-ID1211SE,DR-ID1212SE,DR-ID1213SE54%(High mode)Measurement tolerance (±10%) | Same |
| Detector tiling | One tile | One tile | Same | |
| Method ofDetector Cooling | No special cooling required | No special cooling required | Same | |
| OperatingTemperature (°C) | 15 to 30°C (operating condition)5 to 35°C (non-operating condition) | 15 to 30°C (operating condition)5 to 35°C (non-operating condition) | Same | |
| Auto X-ray | Supported | Supported | Same | |
| DetectionFeature | ||||
| Wireless Feature | ||||
| WirelessSpecifications | IEEE802.11n(2.4GHz, 5.2GHz, 5.3GHz, 5.6GHz, 5.8GHz) | IEEE802.11n(2.4GHz, 5.2GHz, 5.3GHz, 5.6GHz, 5.8GHz) | Same | |
| Security feature | MAC Address Filtering (unique IP address)Wireless LAN SegmentationWPA2-PSK encryption with AES (AdvancedEncryption Standard) | MAC Address Filtering (unique IP address)Wireless LAN SegmentationWPA2-PSK encryption with AES (AdvancedEncryption Standard) | Same | |
| RecommendedWireless AccessPoint | D-Link DAP-2695Silex SX-AP-4800AN2 | D-Link DAP-2695Silex SX-AP-4800AN2Fujifilm AP (853Y120009) | Not related sinceFujifilm AP ismobile-dedicated | |
| BatterySpecifications | ~ 500 exposures or 3 hoursStandby time: ~ 4 hours (max 18 hours with extrasleep mode*)Charging time: ~ 3 hours | ~ 500 exposures or 3 hoursStandby time: ~ 4 hours (max 18 hours with extrasleep mode*)Charging time: ~ 3 hours | Same | |
| AdditionalComponents forWireless feature | Wireless Access Point (WAP)Battery ChargerLi-ion Battery | Wireless Access Point (WAP)Battery ChargerLi-ion Battery | Same | |
| Others | ||||
| Memory storagefunction | No | Yes | Not related(refer to 12.2.3) | |
| Waterproof level | IPX6: Protected against powerful water jets | IPX6: Protected against powerful water jets | Same | |
| Antimicrobialcoating | Ag (silver)-based HYDRO AG coating technology | Ag (silver)-based HYDRO AG coating technology | Same | |
| Imagecompression | Yes | Yes | Same | |
| System Components | ||||
| Grids (Optional) | Custom fit grids (wired)Standard grids (wireless) | Custom fit grids (wired)Standard grids (wireless) | Same | |
| StandardConfigurationComponents | System requiresone or more DR-ID12xxSE detectors,one or two power supply unit(s),one or two or three power box(es)and one control software*. | System requiresone FDX Console,one or more DR-ID12xxSE detectors,one or two power supply unit(s),one or two or three docking stand(s),one or two or three power box(es)and one control unit*. | Substantiallyequivalent exceptfor FDXConsole.The whole systemincluding theConsole isspecified bysystem | |
| *The control software is installed in the Console PC. | *Depending on configuration, the control unit softwarecan be installed in the FDX Console PC. | |||
| integrators. | ||||
| Workstation | N/A | FDX Console Version 8.0 and above | The systemincluding theConsole isspecified by thesystem integrators. | |
| Minimum BasicComputerConfiguration | CPU: Core 2 Duo or later (Performance equivalent ormore), Windows 10, Bus: PCI, RAM: 4GB, Hard Drive:80 GByte | Computer "Off the Shelf" consisting of: Mini Tower,CPU: Core 2 Duo or later (Performance equivalent ormore), Windows 7, Bus: PCI, RAM: 4GB, Hard Drive:80 GByte, Keyboard, Mouse, Barcode scanner, DVDDrive, 17 " or 21" color (touchscreen optional)Monitor. | The PC of thesystem is specifiedby systemintegrators. | |
| ImageProcessing | N/A | EDR, GP, RP, MFP, DRC, FNC,DVII,VG | The imageprocessing isspecified bysystem integrators. | |
| OperatingSystem | Control software (DR-ID1200SDK):Windows 10*32bit or 64bit SP1 | FDX Console:Windows 7*/1032bit or 64bit SP1Power supply unit (DR-ID1200MP):WindRiverLinux2.0 (kernel:2.6.21.7)Control cabinet (DR-ID1200MC):Windows Vista and Windows 7*Control cabinet may not be needed depending onconfiguration. | The operatingsystem of Consoleis specified bysystem integrators. | |
| Image Transfer | N/A | Standard network connectivity via DICOM protocol &via Fuji DMS Network | Standard networkconnectivity isspecified bysystemintegrators. |
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-
Conclusion:
This Special 510(k) premarket notification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. We conclude the subject device to be as safe and effective as the predicate device.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.