DR-ID 1200SDK System

K200668 · Fujifilm Corporation · MQB · Apr 10, 2020 · Radiology

Device Facts

• Record ID: K200668
• Device Name: DR-ID 1200SDK System
• Applicant: Fujifilm Corporation
• Product Code: MQB · Radiology
• Decision Date: Apr 10, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

DR-ID 1200SDK is a flat panel detector system for capturing radiographic images; functions as a component for system integrators to build full radiographic systems. Input: X-ray radiation; Output: Digital radiographic images. Operates via indirect conversion (a-Si) with scintillator (GOS or CsI); utilizes Irradiation Side Sampling (ISS) to reduce blur and improve sharpness/DQE. System lacks integrated console/workstation, docking stand, and memory exposure mode; integrators provide console, image processing, and display. Used in clinical settings for general radiography; operated by radiology staff. Benefits include high-quality digital imaging for general and pediatric applications; enables integration into custom radiographic configurations.

Clinical Evidence

No clinical study performed. Substantial equivalence demonstrated via non-clinical performance data, including software verification/validation and adherence to AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 62304, and IEC 62366-1 standards.

Technological Characteristics

Flat panel detector; indirect conversion (a-Si); scintillator (Gd2O2S:Tb or CsI:Tl); Irradiation Side Sampling (ISS). Connectivity: Wired/Wireless (IEEE 802.11n). Security: MAC filtering, WPA2-PSK/AES. IPX6 waterproof rating. Antimicrobial Ag-based coating. Dimensions: 1.5cm thickness. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 62304, IEC 62366-1.

Indications for Use

Indicated for general projection radiographic imaging of human anatomy, including pediatric and neonatal patients. Contraindicated for mammography, fluoroscopy, tomography, and angiography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• FDR D-EVO II Flat Panel Detector System (K142003)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K200668

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: [phone] Email: [e-mail]

#### 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 Device<br>DR-ID 1200SDK system | Predicate Device<br>K142003, cleared Oct. 21, 2014<br>FDR D-EVO II | Comment for<br>safety and<br>performance | |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Indications for Use | The Wireless/Wired DR-ID 1200SDK system is<br>intended to capture for display radiographic images of<br>human anatomy. It is intended for use in general<br>projection radiographic applications including<br>pediatric and neonatal exams wherever conventional<br>film/screen or CR systems may be used. The DR-ID<br>1200SDK System is not intended for mammography,<br>fluoroscopy, tomography, and angiography<br>applications. | The Wireless/Wired FDR D-EVO II flat panel<br>detector system is intended to capture for display<br>radiographic images of human anatomy. It is<br>intended for use in general projection radiographic<br>applications including pediatric and neonatal exams<br>wherever conventional film/screen or CR systems<br>may be used. The FDR D-EVO II is not intended for<br>mammography, fluoroscopy, tomography, and<br>angiography applications. | Same as the<br>predicate device<br>except the device<br>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)<br>DR-ID1211SE, DR-ID1212SE, DR-ID1213SE CsI:TI<br>(CsI) | DR-ID1201SE, DR-ID1202SE Gd2O2S:Tb (GOS)<br>DR-ID1211SE, DR-ID1212SE, DR-ID1213SE CsI:TI<br>(CsI) | Same | |
| X-ray<br>Conversion | Indirect conversion (a-Si) | Indirect conversion (a-Si) | Same | |
| Unique Detector<br>Characteristic | ISS (irradiation side sampling): captures image from<br>front of detector, reducing blur, resulting in an<br>increase in sharpness and DQE | ISS (irradiation side sampling): captures image from<br>front of detector, reducing blur, resulting in an<br>increase in sharpness and DQE | Same | |
| Detector Cord | Wired / Wireless | Wired / Wireless | Same | |
| Detector Weight<br>(with battery) | DR-ID1201SE : Approx.5.7 lbs (2.5kg)<br>DR-ID1211SE : Approx.5.8 lbs (2.6kg)<br>DR-ID1202SE, DR-ID1212SE : Approx.7.1 lbs (3.2kg)<br>DR-ID1213SE : Approx.3.3 lbs (1.5kg) | DR-ID1201SE : Approx.5.7 lbs (2.5kg)<br>DR-ID1211SE : Approx.5.8 lbs (2.6kg)<br>DR-ID1202SE, DR-ID1212SE : Approx.7.1 lbs (3.2kg)<br>DR-ID1213SE : Approx.3.3 lbs (1.5kg) | Same | |
| Withstand Load | Point load: 1600N (160kg or 352.7 lbs) / ø40mm<br>(1.6in.)<br>Surface load: 3100N (310kg or 683.4 lbs) | Point load: 1600N (160kg or 352.7 lbs) / ø40mm<br>(1.6in.)<br>Surface load: 3100N (310kg or 683.4 lbs) | Same | |
| CR/DR<br>Integration | N/A | FDX Workstation capable of simultaneous connection<br>to Fujifilm CR and FDR D-EVO II | FDX Workstation<br>is not included in<br>the subject<br>device. | |
| Exposure<br>size/Active Area<br>(inch) | DR-ID1201SE, DR-ID1211SE :13.8x16.8<br>DR-ID1202SE, DR-ID1212SE :16.7x16.8<br>DR-ID1213SE : 9.07x11.3 | DR-ID1201SE, DR-ID1211SE : 13.8x16.8<br>DR-ID1202SE, DR-ID1212SE : 16.7x16.8<br>DR-ID1213SE: 9.07x11.3 | Same | |
| Exposure<br>size/Active Area<br>(cm) | DR-ID1201SE, DR-ID1211SE :35.04x42.54<br>DR-ID1202SE, DR-ID1212SE : 42.48x35.05<br>DR-ID1213SE: 23.04x28.80 | DR-ID1201SE, DR-ID1211SE :35.04x42.54<br>DR-ID1202SE, DR-ID1212SE:42.48x35.05<br>DR-ID1213SE: 23.04x28.80 | Same | |
| Number of Pixels | DR-ID1201SE, DR-ID1211SE :2336x2836<br>DR-ID1202SE, DR-ID1212SE :2832x2836<br>DR-ID1213SE: 1536x1920 | DR-ID1201SE, DR-ID1211SE:2336x2836<br>DR-ID1202SE, DR-ID1212SE:2832x2836<br>DR-ID1213SE: 1536x1920 | Same | |
| Dimensions<br>(Detector<br>exterior) | DR-ID1201SE, DR-ID1211SE:<br>38.4cm(W) x 46.0cm(D) x 1.5cm(H)<br>DR-ID1202SE, DR-ID1212SE :<br>46.0cm(W) x 46.0cm(D) x 1.5cm(H)<br>DR-ID1213SE:<br>26.8cm(W) x 32.8cm(D) x 1.5cm(H) | DR-ID1201SE, DR-ID1211SE:<br>38.4cm(W) x 46.0cm(D) x 1.5cm(H)<br>DR-ID1202SE, DR-ID1212SE :<br>46.0cm(W) x 46.0cm(D) x 1.5cm(H)<br>DR-ID1213SE:<br>26.8cm(W) x 32.8cm(D) x 1.5cm(H) | Same | |
| Pixel Size | 150 μm | 150 μm | Same | |
| Acquisition<br>Bit Depth | 16 bit | 16 bit | Same | |
| DQE (RQA5,<br>lp/mm) detector alone,<br>without tabletop | 1<br>- | DR-ID1201SE,DR-ID1202SE<br>31%<br>Measurement tolerance (±10%)<br><br>DR-ID1211SE,DR-ID1212SE,DR-ID1213SE<br>54%<br>Measurement tolerance (±10%) | DR-ID1201SE,DR-ID1202SE<br>31%<br>Measurement tolerance (±10%)<br><br>DR-ID1211SE,DR-ID1212SE,DR-ID1213SE<br>54%<br>Measurement tolerance (±10%) | Same |
| MTF (RQA5,<br>lp/mm) | 2 | DR-ID1201SE,DR-ID1202SE<br>42%(High mode)<br>Measurement tolerance (±10%)<br><br>DR-ID1211SE,DR-ID1212SE,DR-ID1213SE<br>54%(High mode)<br>Measurement tolerance (±10%) | DR-ID1201SE,DR-ID1202SE<br>42%(High mode)<br>Measurement tolerance (±10%)<br><br>DR-ID1211SE,DR-ID1212SE,DR-ID1213SE<br>54%(High mode)<br>Measurement tolerance (±10%) | Same |
| Detector tiling | One tile | One tile | Same | |
| Method of<br>Detector Cooling | No special cooling required | No special cooling required | Same | |
| Operating<br>Temperature (°C) | 15 to 30°C (operating condition)<br>5 to 35°C (non-operating condition) | 15 to 30°C (operating condition)<br>5 to 35°C (non-operating condition) | Same | |
| Auto X-ray | Supported | Supported | Same | |
| Detection<br>Feature | | | | |
| Wireless Feature | | | | |
| Wireless<br>Specifications | IEEE802.11n<br>(2.4GHz, 5.2GHz, 5.3GHz, 5.6GHz, 5.8GHz) | IEEE802.11n<br>(2.4GHz, 5.2GHz, 5.3GHz, 5.6GHz, 5.8GHz) | Same | |
| Security feature | MAC Address Filtering (unique IP address)<br>Wireless LAN Segmentation<br>WPA2-PSK encryption with AES (Advanced<br>Encryption Standard) | MAC Address Filtering (unique IP address)<br>Wireless LAN Segmentation<br>WPA2-PSK encryption with AES (Advanced<br>Encryption Standard) | Same | |
| Recommended<br>Wireless Access<br>Point | D-Link DAP-2695<br>Silex SX-AP-4800AN2 | D-Link DAP-2695<br>Silex SX-AP-4800AN2<br>Fujifilm AP (853Y120009) | Not related since<br>Fujifilm AP is<br>mobile-dedicated | |
| Battery<br>Specifications | ~ 500 exposures or 3 hours<br>Standby time: ~ 4 hours (max 18 hours with extra<br>sleep mode*)<br>Charging time: ~ 3 hours | ~ 500 exposures or 3 hours<br>Standby time: ~ 4 hours (max 18 hours with extra<br>sleep mode*)<br>Charging time: ~ 3 hours | Same | |
| Additional<br>Components for<br>Wireless feature | Wireless Access Point (WAP)<br>Battery Charger<br>Li-ion Battery | Wireless Access Point (WAP)<br>Battery Charger<br>Li-ion Battery | Same | |
| Others | | | | |
| Memory storage<br>function | No | Yes | Not related<br>(refer to 12.2.3) | |
| Waterproof level | IPX6: Protected against powerful water jets | IPX6: Protected against powerful water jets | Same | |
| Antimicrobial<br>coating | Ag (silver)-based HYDRO AG coating technology | Ag (silver)-based HYDRO AG coating technology | Same | |
| Image<br>compression | Yes | Yes | Same | |
| System Components | | | | |
| Grids (Optional) | Custom fit grids (wired)<br>Standard grids (wireless) | Custom fit grids (wired)<br>Standard grids (wireless) | Same | |
| Standard<br>Configuration<br>Components | System requires<br>one or more DR-ID12xxSE detectors,<br>one or two power supply unit(s),<br>one or two or three power box(es)<br>and one control software*. | System requires<br>one FDX Console,<br>one or more DR-ID12xxSE detectors,<br>one or two power supply unit(s),<br>one or two or three docking stand(s),<br>one or two or three power box(es)<br>and one control unit*. | Substantially<br>equivalent except<br>for FDX<br>Console.<br><br>The whole system<br>including the<br>Console is<br>specified by<br>system | |
| | *The control software is installed in the Console PC. | *Depending on configuration, the control unit software<br>can be installed in the FDX Console PC. | | |
| | | | integrators. | |
| Workstation | N/A | FDX Console Version 8.0 and above | The system<br>including the<br>Console is<br>specified by the<br>system integrators. | |
| Minimum Basic<br>Computer<br>Configuration | CPU: Core 2 Duo or later (Performance equivalent or<br>more), Windows 10, Bus: PCI, RAM: 4GB, Hard Drive:<br>80 GByte | Computer "Off the Shelf" consisting of: Mini Tower,<br>CPU: Core 2 Duo or later (Performance equivalent or<br>more), Windows 7, Bus: PCI, RAM: 4GB, Hard Drive:<br>80 GByte, Keyboard, Mouse, Barcode scanner, DVD<br>Drive, 17 " or 21" color (touchscreen optional)<br>Monitor. | The PC of the<br>system is specified<br>by system<br>integrators. | |
| Image<br>Processing | N/A | EDR, GP, RP, MFP, DRC, FNC,DVII,VG | The image<br>processing is<br>specified by<br>system integrators. | |
| Operating<br>System | Control software (DR-ID1200SDK):<br>Windows 10<br>*32bit or 64bit SP1 | FDX Console:<br>Windows 7*/10<br>*32bit or 64bit SP1<br>Power supply unit (DR-ID1200MP):<br>WindRiverLinux2.0 (kernel:2.6.21.7)<br>Control cabinet (DR-ID1200MC)*:<br>Windows Vista and Windows 7<br>*Control cabinet may not be needed depending on<br>configuration. | The operating<br>system of Console<br>is specified by<br>system integrators. | |
| Image Transfer | N/A | Standard network connectivity via DICOM protocol &<br>via Fuji DMS Network | Standard network<br>connectivity is<br>specified by<br>system<br>integrators. | |

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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.