ControlRad Trace Model 9

K200663 · Controlrad, Inc. · OWB · Jun 24, 2020 · Radiology

Device Facts

• Record ID: K200663
• Device Name: ControlRad Trace Model 9
• Applicant: Controlrad, Inc.
• Product Code: OWB · Radiology
• Decision Date: Jun 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The ControlRad™ Trace Model 9, when used with OEC® 9900 Elite, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to OEC® 9900 Elite non-collimated image area. 1 The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9900 Elite's collimators, as they block the most radiation, but can help physicians balance dose visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

Device Story

System consists of tablet, semi-transparent filter, hardware, and software modules installed on GE OEC 9900 Elite fluoroscopic X-ray system. Clinician selects Region of Interest (ROI) via tablet GUI; system controls filter positioning to reduce radiation outside ROI while maintaining full image quality within ROI. Filter provides 61-97% radiation reduction in peripheral areas. Used in OR/clinic by physicians to balance dose reduction with peripheral visualization. Output includes live fluoroscopic images with ROI overlay and DAP metrics. Benefits include reduced radiation exposure for patients and clinicians.

Clinical Evidence

Bench testing only. Evaluated Air Kerma impact, DAP calculation accuracy (within ±35%), DAP reduction (≥50% at 50kVp), filter attenuation, and comparative image quality (inside/outside ROI). Clinical simulations confirmed peripheral context utility. Usability testing verified touchscreen operation with sterile gloves. Mechanical testing confirmed compliance with IEC 60601-1 for instability.

Technological Characteristics

System integrates with GE OEC 9900 Elite. Components: Tablet, semi-transparent filter, hardware/firmware modules, communication interface. Filter reduces radiation outside ROI by 61-97%. Connectivity: Wireless/wired communication with host X-ray system. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 62304, ISO 14971, 21 CFR 1020.30-32.

Indications for Use

Indicated for patients undergoing diagnostic, surgical, and interventional fluoroscopic and spot-film imaging procedures, including cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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

• ControlRad™ Trace Model 8 (K183109)

Reference Devices

• GE Healthcare Surgery, OEC® 9900 Elite (K122234)

Submission Summary (Full Text)

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June 24, 2020

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

ControlRad, Inc. % Linda Braddon, Ph.D. Regulatory Consultant Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 WOODSTOCK GA 30188

Re: K200663

Trade/Device Name: ControlRad™ Trace Model 9 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: April 9, 2020 Received: April 10, 2020

Dear Dr. Braddon:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 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 ([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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K200663

Device Name

#### ControlRad™ Trace Model 9

Indications for Use (Describe)

The ControlRad™ Trace Model 9, when used with OEC® 9900 Elite, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to OEC® 9900 Elite non-collimated image area. 1 The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9900 Elite's collimators, as they block the most radiation, but can help physicians balance dose visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

1 Relative to open Field of View (FOV), the ControlRad Trace Model 9 reduces at least 50% of the Dose Area Product at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.

Type of Use (Select one or bothas applicable)

図 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C

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Image /page/3/Picture/0 description: The image shows the logo for ControlRad. The logo is in green and white. The word "CONTROL" is in dark green, and the word "RAD" is in light green. There is a green circle around the "RAD" part of the logo.

# 510(k) SUMMARY

# ControlRad, Inc's ControlRadTM Trace Model 9

## K200663

| Applicant's name: | ControlRad, Inc.<br>275 Scientific Dr NW<br>Suite 1100<br>Norcross, Georgia 30092, USA<br>P: 1-800-522-5148 |
|-------------------|-------------------------------------------------------------------------------------------------------------|
|-------------------|-------------------------------------------------------------------------------------------------------------|

- Contact Person: Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Hwy Suite 120 Woodstock, GA 30188 770-837-2681 [e-mail]
Date Prepared: June 15, 2020

# Subject Device:

| Device Name | ControlRad™ Trace Model 9 |
|---------------------|---------------------------------------------|
| Common Name | Interventional Fluoroscopic X-ray System |
| Regulation | 21 CFR §892.1650 |
| Classification Name | Image-intensified fluoroscopic x-ray system |
| Class | II |
| Panel | Radiology |
| Product Code(s) | Primary: OWB<br>Secondary: OXO, JAA |

## Predicate Device:

| Device Name | ControlRad™ Trace Model 8 (K183109) |
|---------------------|---------------------------------------------|
| Common Name | Interventional Fluoroscopic X-ray System |
| Regulation | 21 CFR §892.1650 |
| Classification Name | Image-intensified fluoroscopic x-ray system |
| Class | II |
| Panel | Radiology |
| Product Code(s) | Primary: OWB<br>Secondary: OXO, JAA |

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Image /page/4/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in dark teal, followed by "RAD" in a lighter green. To the right of "RAD" is a circular design with a dark teal lower half and a light green upper half. The letters "RAD" are integrated into the circular design, and there is a trademark symbol to the upper right of the logo.

#### Reference Device:

GE Healthcare Surgery, OEC® 9900 Elite (K122234) Device Name Common Name Interventional Fluoroscopic X-ray System Regulation 21 CFR §892.1650 Classification Name Image-intensified fluoroscopic x-ray system Class II Radiology Panel Product Code(s) Primary: OWB Secondary: OXO, JAA

## Indications for Use

The ControlRad™ Trace Model 9, when used with OEC® 9900 Elite, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to OEC® 9900 Elite noncollimated image area.1 The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9900 Elite's collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

1 Relative to open Field of View (FOV), the ControlRad Trace Model 9 reduces at least 50% of the Dose Area Product at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.

#### Device Description

The ControlRad™ Trace Model 9 consists of the following main components: ControlRad Trace Tablet, ControlRad Trace Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication Interface all installed on the OEC 9900 Elite. The ControlRad™ Trace Model 9 is a system used to assist trained clinicians which is used to provide X-ray images when the clinician performs a medical procedure while reducing the patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to the OEC 9900 Elite non-collimated image area. The ControlRad™ Trace Model 9 can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.

#### Technological Characteristics

The ControlRad™ Trace Model 9 consists of the following main components: ControlRad Trace Tablet, ControlRad Trace Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication Interface all installed on the OEC 9900 Elite.

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Image /page/5/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in a bold, sans-serif font, followed by the word "RAD" in a similar font but with a green color. To the right of "RAD" is a stylized green circle, partially enclosing the letters "RAD", with a darker green section at the bottom. There is a trademark symbol to the right of the word "RAD".

The ControlRad" Trace Model 9 components are installed semi-permanently in the cleared GE Healthcare Surgery's OEC® 9900 Elite (K122234) and operate in parallel to the GE Healthcare Surgery's OEC® 9900 Elite. The removal of the ControlRad™ components will restore the device to OEM specifications.

The ControlRad™ Trace Model 9 components provide the following functionalities:

- The CR Trace Tablet provides the user operational control of the ControlRad™ Trace . Model 9 device via a Graphical User Interface ("GUI"). The CR Trace Tablet enables the clinician to select a Region of Interest ("ROI") on the image displayed on the CR Trace Tablet, which is the same image that is displayed on the GE Healthcare Surgery's OEC® 9900 Elite's live monitor.
- . The CR Trace Filter is installed on top of the GE Healthcare Surgery's OEC® 9900 Elite's collimator. The CR Trace Filter does not affect or modify the functionality of the collimator. The CR Trace Filter is a semi-transparent filter which reduces the X-ray radiation outside the clinician-selected ROI, typically by 61% to 97%. The actual dose reduction achieved will depend upon specific imaging parameters such as OEC collimator settings, the kVp and the percentage of the OEC non-collimated image covered by the ControlRad Trace Filter.
- The ControlRad Hardware, Software and Firmware Modules control the ControlRad Trace . Filter's positioning, which is determined by the location of the clinician-selected ROI and perform image processing.
- The ControlRad Communication Interface provides communication between the various . components of the ControlRad™ Trace Model 9 and between the ControlRad™ Trace Model 9 and the GE Healthcare Surgery's OEC® 9900 Elite.

## Principles of Operation

The GE Healthcare Surgery's OEC® 9900 Elite provides an image that its boundaries are defined by the OEC® 9900 Elite's collimator, i.e. the image FOV is defined by the OEC non-collimated region. The image FOV size is not affected or modified by the ControlRad™ Trace Model 9.

Within the OEC® 9900 Elite non-collimated image region, when using a clinician selected Region of Interest ("ROI") on the ControlRad Trace Tablet, the ControlRad Trace Filters reduce radiation exposure outside the ROI. The resulting image has two parts:

- . The image inside the clinician-selected ROI (unfiltered radiation area in the FOV), which has at least the same image quality in the ROI as the GE Healthcare Surgery's OEC® 9900 Elite (K122234); and

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Image /page/6/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in a dark teal sans-serif font, followed by "RAD" in a lighter green color. To the right of "RAD" is a circular design with two shades of green, creating a stylized "C" shape. The letters and the circular design are aligned horizontally.

- . The image outside the clinician-selected ROI (filtered radiation area in the FOV), a lowerdose processed image which provides peripheral image context to the ROI.
The GE Healthcare Surgery's OEC® 9900 Elite's collimator, when used, also reduces radiation emission. However, that collimator reduces radiation emission by blocking the delivery of radiation to the area covered by the collimator. As a result, the GE Healthcare Surgery's OEC® 9900 Elite's image FOV is limited to the non-collimated region. The ControlRad Trace Filter can be used along with the GE Healthcare Surgery's OEC® 9900 Elite's collimator to further reduce radiation emissions, and the additional radiation reduction provided by the ControlRad Trace Filter will be outside the clinician-selected ROI and within the un-collimated region/image FOV.

The clinician has the option not to use the CR Trace Filter. In this case, the GE Healthcare Surgery's OEC® 9900 Elite operates as if the CR Trace Filter was not present.

## Comparison of Technological Characteristics with the Predicate devices

The ControlRad™ Trace Model 9 for use with GE Healthcare Surgery's OEC® 9900 Elite has the same intended use and the same indications for use as the cleared predicate. The ControlRad™ Trace Model 9 is identical in construction to the predicate with the only modifications being the design differences to work with OEC® 9900 Elite. The performance data demonstrates that the ControlRad™ Trace Model 9 is at least as safe and effective as the predicate and reference devices and is substantially equivalent to the predicate and reference devices. A comparison table of technological characteristics of the ControlRad™ Trace Model 9 device for use with OEC® 9900 Elite compared to those of the predicates is provided below:

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Image /page/7/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a bold, sans-serif font in a dark teal color. To the right of the word "CONTROL" is the word "RAD" in a lighter green color, with a circle around it that is also green. The letters "RAD" are also in a bold, sans-serif font.

| Device<br>Feature<br>510(k) Number | ControlRad, Inc's<br>ControlRad™ Trace<br>Model 9<br>(Subject Device)<br>K200663 | ControlRad, Inc's<br>ControlRad™ Trace<br>Model 8<br>(K183109)<br>(Predicate Device)<br>K183109 | GE Healthcare<br>Surgery's<br>OEC 9900 Elite<br>(K122234)<br>(Reference)<br>K122234 | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Device Class | Class II | Class II | Class II | |
| Product Codes | Primary: OWB<br>Secondary: OXO, JAA | Primary: OWB<br>Secondary: OXO, JAA | Primary: OWB<br>Secondary: OXO, JAA | |
| Regulation Number | 21 CFR §892.1650 | 21 CFR §892.1650 | 21 CFR §892.1650 | |
| Indications for use | The ControlRad™ Trace Model<br>9, when used with OEC® 9900<br>Elite, is indicated to provide<br>fluoroscopic and spot-film<br>imaging of the patient during<br>diagnostic, surgical, and<br>interventional procedures while<br>reducing patients and clinicians'<br>radiation exposure (Dose Area<br>Product) outside of the<br>ControlRad Trace's region of<br>interest (ROI) as compared to<br>OEC® 9900 Elite non-<br>collimated image area.1 The<br>ControlRad Trace semi-<br>transparent filter should not be<br>used in lieu of the OEC® 9900<br>Elite's collimators, as they<br>block the most radiation, but<br>can help physicians balance<br>dose reduction with the need to<br>visualize structures outside the<br>ROI when it is considered<br>clinically advantageous to do<br>so. Clinical applications may<br>include cholangiography.<br>endoscopic, urologic,<br>orthopedic, neurologic,<br>vascular, cardiac, critical care<br>and emergency room<br>procedures.<br>1Relative to open Field of View<br>(FOV), the ControlRad Trace<br>Model 9 reduces at least 50% of<br>the Dose Area Product at 50<br>kVp and ROI with width and<br>length that are smaller than 1/3<br>the diameter of the full FOV. | The ControlRad™ Trace Model<br>8, when used with OEC®<br>9800/OEC® 9800 Plus, is<br>indicated to provide<br>fluoroscopic and spot-film<br>imaging of the patient during<br>diagnostic, surgical, and<br>interventional procedures while<br>reducing patients and clinicians'<br>radiation exposure (Dose Area<br>Product) outside of the<br>ControlRad Trace's region of<br>interest (ROI) as compared to<br>the OEC® 9800/OEC® 9800<br>Plus non-collimated image<br>area.1 The ControlRad Trace<br>semi-transparent filter should<br>not be used in lieu of the<br>OEC® 9800/OEC® 9800 Plus'<br>collimators, as they block the<br>most radiation, but can help<br>physicians balance dose<br>reduction with the need to<br>visualize structures outside the<br>ROI when it is considered<br>clinically advantageous to do<br>so. Clinical applications may<br>include cholangiography,<br>endoscopic, urologic,<br>orthopedic, neurologic,<br>vascular, cardiac, critical care<br>and emergency room<br>procedures.<br>1Relative to open Field of View<br>(FOV), the ControlRad Trace<br>Model 8 reduces at least 50%<br>of the Dose Area Product at 50<br>kVp and ROI with width and<br>length that are smaller than 1/3<br>the diameter of the full FOV. | The OEC® 9900 Elite is<br>designed to provide<br>fluoroscopic and spot-film<br>images of the patient during<br>diagnostic, surgical and<br>interventional procedures.<br>Examples of clinical<br>application may include<br>cholangiography, endoscopy,<br>urologic, orthopedic,<br>neurologic, vascular, cardiac,<br>critical care and emergency<br>room procedures. | |
| X-ray Modulation | | | | |
| X-ray Modulation<br>Component | CR Trace Filter | CR Trace Filter | Iris Collimator and<br>Semitransparent<br>Leaf/Leaves Collimator | |
| Device | ControlRad, Inc's<br>ControlRad™ Trace<br>Model 9<br>(Subject Device) | ControlRad, Inc's<br>ControlRad™ Trace<br>Model 8<br>(K183109)<br>(Predicate Device) | GE Healthcare<br>Surgery's<br>OEC 9900 Elite<br>(K122234)<br>(Reference) | |
| Feature | | | | |
| X-ray Radiation<br>Modulation | Reduces X-ray radiation<br>outside the aperture/ROI<br>typically by 61% to 97% | Reduces X-ray radiation<br>outside the aperture/ROI<br>typically by 61% to<br>97% | Completely blocks X-<br>ray radiation outside the<br>aperture | |
| Aperture shape | Rectangular | Rectangular | Leaf/Leaves:<br>Rectangular-Like<br>(2 straight edges and 2<br>round edges)<br>Iris: Octagonal. | |
| Aperture Control | Set by the user using the<br>CR Trace Tablet | Set by the user using the<br>CR Trace Tablet | Set by the user using the<br>Collimator Control<br>buttons on GE<br>Healthcare Surgery's<br>OEC® 9900 Elite's c-<br>arm unit control panel | |
| Image Processing | | | | |
| Image Area<br>Processed | Image area outside the<br>ROI | Image area outside the<br>ROI | Entire Image | |
| Processing Bits | 12 bits | 12 bits | 12 bits | |
| Processing Rate | 30 fps | 30 fps | 30 fps | |
| Processing<br>Occurrence | Only when the CR<br>Trace Filter is engaged | Only when the CR<br>Trace Filter is engaged | At all times | |
| Image Layout<br>Information | Dose Area Product<br>(DAP) value and/or<br>percentage of DAP<br>reduction when using<br>ControlRad Trace Filter<br>and/or OEC Collimators<br>ROI frame border | Dose Area Product<br>(DAP) value and/or<br>percentage of DAP<br>reduction when using<br>ControlRad Trace Filter<br>and/or OEC Collimators<br>ROI frame border | Hospital, Physician and<br>Patient's name, date and<br>time, X-ray Generator's<br>voltage and current<br>settings, Brightness and<br>Contrast settings,<br>Magnification level,<br>Accumulated Exposure<br>Time per Examination,<br>Accumulated Air Kerma | |
| Parameters Accuracy Specifications | Dose Area Product<br>(DAP) Accuracy for<br>total x-ray field of<br>the ControlRad<br>Trace Filter and<br>OEC systems<br>combined* | *Overall: ±35%<br>For DAP reported by<br>ControlRad™ Trace<br>Model 9 | *Overall: ±35%<br>For DAP reported by<br>ControlRad™ Trace<br>Model 8 | Overall accuracy: ±40%<br>(with Iris Field and<br>Sutter Field > 5cm). |
| Electrical Requirements | Electrical<br>Requirements | 60 / 50 Hz; 120 VAC<br>(±10%), 15A | 60 / 50 Hz; 120 VAC<br>(±10%), 15A | 60 / 50 Hz; 120 VAC<br>(±10%), 15A |
| Device<br>Feature | ControlRad, Inc's<br>ControlRad™ Trace<br>Model 9<br>(Subject Device) | ControlRad, Inc's<br>ControlRad™ Trace<br>Model 8<br>(K183109)<br>(Predicate Device)…