(28 days)
Not Found
No
The document explicitly states that the software package is unchanged from the predicate device (K142003), and there is no mention of AI, ML, or related terms in the description or performance studies. The focus is on the detector hardware and basic image processing.
No
The device is described as capturing radiographic images for display and is indicated for general projection radiographic applications. It is an imaging device, not one that directly treats a condition or disease.
Yes
The device is intended to capture and display radiographic images of human anatomy for general projection radiographic applications, which are used by healthcare professionals to diagnose various conditions.
No
The device description explicitly states it is a "detector/software system" and is an alternative system added to a "Flat Panel Detector System," indicating it includes hardware components (the detector).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "captur[ing] for display radiographic images of human anatomy." This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (which is the definition of an IVD).
- Device Description: The description details a detector/software system for capturing x-ray images. This aligns with diagnostic imaging, not in vitro testing.
- Input Imaging Modality: The input modality is "x-ray," which is a form of medical imaging, not a method for analyzing biological samples.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., outside of the body to provide information about a person's health. This device is used to create images of the inside of the body using x-rays.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
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 fully-operational 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
pediatric and neonatal exams, general projection radiographic applications (implying all ages)
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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/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
2
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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3
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.
4
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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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:
6
| | Subject Device
DR-ID 1200SDK system | Predicate Device
K142003, cleared Oct. 21, 2014
FDR D-EVO II | Comment for
safety and
performance | |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Indications for Use | 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 Wireless/Wired FDR D-EVO II flat panel
detector 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 FDR D-EVO II is not intended for
mammography, fluoroscopy, tomography, and
angiography applications. | Same as the
predicate device
except the device
name | |
| 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-ray
Conversion | Indirect conversion (a-Si) | Indirect conversion (a-Si) | Same | |
| Unique Detector
Characteristic | ISS (irradiation side sampling): captures image from
front of detector, reducing blur, resulting in an
increase in sharpness and DQE | ISS (irradiation side sampling): captures image from
front of detector, reducing blur, resulting in an
increase 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/DR
Integration | N/A | FDX Workstation capable of simultaneous connection
to Fujifilm CR and FDR D-EVO II | FDX Workstation
is not included in
the subject
device. | |
| Exposure
size/Active Area
(inch) | DR-ID1201SE, DR-ID1211SE :13.8x16.8
DR-ID1202SE, DR-ID1212SE :16.7x16.8
DR-ID1213SE : 9.07x11.3 | DR-ID1201SE, DR-ID1211SE : 13.8x16.8
DR-ID1202SE, DR-ID1212SE : 16.7x16.8
DR-ID1213SE: 9.07x11.3 | Same | |
| Exposure
size/Active Area
(cm) | DR-ID1201SE, DR-ID1211SE :35.04x42.54
DR-ID1202SE, DR-ID1212SE : 42.48x35.05
DR-ID1213SE: 23.04x28.80 | DR-ID1201SE, DR-ID1211SE :35.04x42.54
DR-ID1202SE, DR-ID1212SE:42.48x35.05
DR-ID1213SE: 23.04x28.80 | Same | |
| Number of Pixels | DR-ID1201SE, DR-ID1211SE :2336x2836
DR-ID1202SE, DR-ID1212SE :2832x2836
DR-ID1213SE: 1536x1920 | DR-ID1201SE, DR-ID1211SE:2336x2836
DR-ID1202SE, DR-ID1212SE:2832x2836
DR-ID1213SE: 1536x1920 | Same | |
| Dimensions
(Detector
exterior) | 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 | |
| Acquisition
Bit Depth | 16 bit | 16 bit | Same | |
| DQE (RQA5,
lp/mm) detector alone,
without tabletop | 1
-
| DR-ID1201SE,DR-ID1202SE
31%
Measurement tolerance (±10%)
DR-ID1211SE,DR-ID1212SE,DR-ID1213SE
54%
Measurement tolerance (±10%) | DR-ID1201SE,DR-ID1202SE
31%
Measurement tolerance (±10%)
DR-ID1211SE,DR-ID1212SE,DR-ID1213SE
54%
Measurement tolerance (±10%) | Same |
| MTF (RQA5,
lp/mm) | 2 | DR-ID1201SE,DR-ID1202SE
42%(High mode)
Measurement tolerance (±10%)
DR-ID1211SE,DR-ID1212SE,DR-ID1213SE
54%(High mode)
Measurement tolerance (±10%) | DR-ID1201SE,DR-ID1202SE
42%(High mode)
Measurement tolerance (±10%)
DR-ID1211SE,DR-ID1212SE,DR-ID1213SE
54%(High mode)
Measurement tolerance (±10%) | Same |
| Detector tiling | One tile | One tile | Same | |
| Method of
Detector Cooling | No special cooling required | No special cooling required | Same | |
| Operating
Temperature (°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 | |
| Detection
Feature | | | | |
| Wireless Feature | | | | |
| Wireless
Specifications | 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 Segmentation
WPA2-PSK encryption with AES (Advanced
Encryption Standard) | MAC Address Filtering (unique IP address)
Wireless LAN Segmentation
WPA2-PSK encryption with AES (Advanced
Encryption Standard) | Same | |
| Recommended
Wireless Access
Point | D-Link DAP-2695
Silex SX-AP-4800AN2 | D-Link DAP-2695
Silex SX-AP-4800AN2
Fujifilm AP (853Y120009) | Not related since
Fujifilm AP is
mobile-dedicated | |
| Battery
Specifications | ~ 500 exposures or 3 hours
Standby time: ~ 4 hours (max 18 hours with extra
sleep mode*)
Charging time: ~ 3 hours | ~ 500 exposures or 3 hours
Standby time: ~ 4 hours (max 18 hours with extra
sleep mode*)
Charging time: ~ 3 hours | Same | |
| Additional
Components for
Wireless feature | Wireless Access Point (WAP)
Battery Charger
Li-ion Battery | Wireless Access Point (WAP)
Battery Charger
Li-ion Battery | Same | |
| Others | | | | |
| Memory storage
function | No | Yes | Not related
(refer to 12.2.3) | |
| Waterproof level | IPX6: Protected against powerful water jets | IPX6: Protected against powerful water jets | Same | |
| Antimicrobial
coating | Ag (silver)-based HYDRO AG coating technology | Ag (silver)-based HYDRO AG coating technology | Same | |
| Image
compression | Yes | Yes | Same | |
| System Components | | | | |
| Grids (Optional) | Custom fit grids (wired)
Standard grids (wireless) | Custom fit grids (wired)
Standard grids (wireless) | Same | |
| Standard
Configuration
Components | System requires
one 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 requires
one 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*. | Substantially
equivalent except
for FDX
Console.
The whole system
including the
Console is
specified by
system | |
| | *The control software is installed in the Console PC. | *Depending on configuration, the control unit software
can be installed in the FDX Console PC. | | |
| | | | integrators. | |
| Workstation | N/A | FDX Console Version 8.0 and above | The system
including the
Console is
specified by the
system integrators. | |
| Minimum Basic
Computer
Configuration | CPU: Core 2 Duo or later (Performance equivalent or
more), 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 or
more), Windows 7, Bus: PCI, RAM: 4GB, Hard Drive:
80 GByte, Keyboard, Mouse, Barcode scanner, DVD
Drive, 17 " or 21" color (touchscreen optional)
Monitor. | The PC of the
system is specified
by system
integrators. | |
| Image
Processing | N/A | EDR, GP, RP, MFP, DRC, FNC,DVII,VG | The image
processing is
specified by
system integrators. | |
| Operating
System | Control software (DR-ID1200SDK):
Windows 10
32bit or 64bit SP1 | FDX Console:
Windows 7/10
32bit or 64bit SP1
Power 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 on
configuration. | The operating
system of Console
is specified by
system integrators. | |
| Image Transfer | N/A | Standard network connectivity via DICOM protocol &
via Fuji DMS Network | Standard network
connectivity is
specified by
system
integrators. | |
7
8
9
10
-
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.