DC-Air and Athlos-1 and Athlos-Air

K211688 · Athlos OY · MUH · Jul 22, 2021 · Dental

Device Facts

• Record ID: K211688
• Device Name: DC-Air and Athlos-1 and Athlos-Air
• Applicant: Athlos OY
• Product Code: MUH · Dental
• Decision Date: Jul 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

DC-Air™, Athlos-1, Athlos-Air digital sensor systems are intended for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure. DC-Air™, Athlos-1, Athlos-Air digital sensors are intended to capture an intraoral X-ray image, when exposed to X-rays, for dental diagnostic purposes.

Device Story

Wireless intraoral digital X-ray system comprising a sensor, docking station, and imaging software. Sensor captures X-ray images using Direct Conversion Technology (silicon detector bump-bonded to ASIC); transmits data via Bluetooth 5.0 to docking station; docking station relays data to PC via USB 2.0. Sensor includes rechargeable battery and on-board image RAM for temporary storage. Used by dental professionals in clinical settings. System integrates with existing wall-mounted or portable X-ray generators (2-15mA, 50-75kV); device does not control generators. Output displayed on PC via Archimed Suite imaging software. Benefits include wireless operation and improved image sharpness via direct conversion compared to indirect scintillator-based sensors.

Clinical Evidence

Bench testing only. Performance evaluated via MTF and DQE metrics per IEC 62220-1-1. Qualitative clinical assessment performed by three dentists (Robert Sachs, John M. Steinberg, Steven R. Gluck) who confirmed images were diagnostically relevant and reliable.

Technological Characteristics

Direct Conversion Si-CMOS sensor; Polyphensylsulfone housing (V-0 flammability); Bluetooth 5.0 wireless connectivity; USB 2.0 docking station; battery-powered sensor; IP67/IP64 rated. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 62220-1-1 (performance), IEC 60529 (IP code).

Indications for Use

Indicated for radiographic examination by dental professionals to assist in diagnosing diseases of teeth, jaw, and oral structures in general populations.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• QuickRay HD (K151926)

Reference Devices

• Dentrix Ascend Imaging (K151438)
• Apteryx XrayVision (K983111)
• DEXIS Software (K090431)
• DEEP View (K160386)

Submission Summary (Full Text)

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July 22, 2021

Image /page/0/Picture/1 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Athlos Oy % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114

Re: K211688

Trade/Device Name: DC-Air" and Athlos-1 and Athlos-Air Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: July 7, 2021 Received: July 12, 2021

Dear Prithul Bom:

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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### Indications for Use

510(k) Number (if known) K211688

Device Name DC-Air™, Athlos-1, Athlos-Air

#### Indications for Use (Describe)

DC-Air™, Athlos-1, Athlos-Air are intended to be used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw, and oral structures.

DC-Air™, Athlos-1, Athlos-Air are suitable for general populations.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image is a logo for ATHLOS. The logo features a stylized red figure in motion, resembling a runner or athlete. The figure is composed of geometric shapes, giving it a dynamic and modern appearance. The word "ATHLOS" is written in bold, sans-serif font to the right of the figure.

# K211688 510(k) Summary

In accordance with 21 CFR 807.92, the following summary of information is provided:

#### Submitter 1

| Name: | Athlos Oy |
|---------------------------|-----------------------------------------------------------------|
| Address: | Klovinpellontie 1-3, 02180 Espoo, FINLAND |
| Phone: | [phone] |
| Fax: | N/A |
| Primary Contact Person: | Linda Kellberg, Quality Manager, [e-mail] |
| Secondary Contact Person: | Konstantinos Spartiotis, CEO, [e-mail] |
| Date Prepared: | June 29, 2021 |

#### Device Classification 2

| Trade Names: | DC-Air™, Athlos-1, Athlos-Air |
|-----------------------|--------------------------------|
| Common Name: | Intraoral Digital X-ray Sensor |
| Regulation Number: | 21 CFR 872.1800 |
| Classification Name: | Extraoral Source X-ray System |
| Product Code: | MUH |
| Submission Type: | 510(k) |
| Regulatory Class: | 2 |
| Classification Panel: | Radiology |

#### Predicate Device 3

The following predicate is a legally marketed device:

| 510(k) Number: | K151926 |
|--------------------|-------------------|
| Clearance Date: | December 14, 2015 |
| Actual Trade Name: | QuickRay HD |
| Regulation Number: | 21 CFR 872.1800 |
| Product Code: | MUH |

#### Device Description 4

The subject device DC-Air™ (also known as Athlos-Air) is a wireless intraoral digital X-ray system that comprises of three (3) main components:

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Image /page/4/Picture/0 description: The image shows the logo for Athlos. The logo features a stylized red figure of a person running, with geometric shapes behind them. To the right of the figure is the word "ATHLOS" in a bold, sans-serif font.

- (1) An intraoral X-ray image detector (sensor) with rechargeable battery for capturing X-ray images and which connects to the docking station via a wireless communications protocol (Bluetooth 5.0),
- (2) A docking station that acts as the receiver of the data (X-ray image) sent by the detector and which forwards the data to the operator's personal computer (PC) via USB connection. Also, the docking station functions as a charging station of the detector, and
- (3) An Imaging Software package.

DC-Air™ digital intraoral sensor:

- Outer measurement: 43.4mm=0.3mm x 29.5mm=0.3mm x 5.4±0.3mm (9.4±0.3mm with battery compartment)
- Active area: 35.1mm x 24.7mm (867 mm²) —
- -Weight: 12.2±0.8g

DC-Air™ docking station:

- Outer measurements: 54.2±2.0mm (without antenna), ø 100±2.0mm
- Weight: 200±50g and maximum 400g ballast (user choice) —

The three (3) different brand names are for marketing purposes.

The DC-Air™ intraoral sensor features a Size 2 digital X-ray imaging device for dental intraoral diagnosis. The DC-Air™ utilizes Bluetooth (5.0) Low Energy technology to transfer the captured X-ray image from the DC-Air™ sensor to the docking station which further relays it to a connected diagnostics PC. The sensor operates with an integrated battery that can be recharged by placing it on the docking station.

DC-Air™ utilizes Direct Conversion Technology which comprises Silicon as the detector material bump bonded to a full custom ASIC. The sensor features on-board automatic X-ray detection and triggering. The sensor can be used at up to 3m (9f) from the docking station which utilizes a USB2.0 port for "plug-n-play" operation. The sensor also incorporates an image RAM where each X-ray is temporarily stored pending transmission but can be retrieved at any time before the next acquisition.

Before the Athlos' importer in the US sells this device, their technicians discuss the hardware and software that the dentist has, to make sure that their systems are compatible with DC-Air™. The importer offers technical support for this device to ensure proper operation and to answer any questions regarding the function of the device. A means to contact the importer is provided to all end users and in the operator's manual.

The types of X-ray systems that integrate with the DC-Air™ are wall-mounted or wheeled X-ray generators (both AC and DC) with a tube current between 2mA and 15mA inclusive, and with a tube voltage between 50kV and 75kV inclusive, with in-built controls to set exposure parameters. Generators allow variable mA/kV to be selected, all will control the exposure time. Alternatively,

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Image /page/5/Picture/0 description: The image shows the logo for Athlos. The logo features a stylized red figure of a person running or in motion, composed of geometric shapes. To the right of the figure is the word "ATHLOS" in a bold, sans-serif font. The logo has a dynamic and athletic feel.

the DC-Air™ can be used in conjunction with a portable, handheld X-ray generator with a tube current between 2mA and 10mA inclusive and with a tube voltage 50kV and 75kV inclusive.

The DC-Air™ sensor system cannot act as an X-ray generator controller. All control of X-ray generation is done by controls built into the generator itself. There is no connection between the subject device and the X-ray generator. The subject device does not control the generator, it is a receiver.

The DC-Air™ (or Athlos-1 or Athlos-Air) Imaging Software is supported by Windows 7 and 10. The absolute minimum requirements for PC hardware for the sensor and software combination would be an Intel i5 6th generation processor or equivalent. At least 4 GB of RAM, 100GB of hard drive space to accommodate a) the software, b) the space necessary for the repository of images generated by DC-Air™ backup, and c) logging of errors and messages. The PC should have a USB 2.0 Port. The TWAIN interface provided by the DC-Air™ sensor system may also bridge the images to other FDA-cleared imaging and practice management software.

The DC-Air™ intraoral sensor and docking station can also be used with other FDA-cleared imaging software and practice management systems, including Dentrix Ascend Imaging (K151438, cleared July 7, 2015), Apteryx XrayVision (K983111, cleared Nov. 16, 1998), and DEXIS Software (K090431, cleared June 22, 2009). The supported operating systems are Windows 7 and 10. The used PC should meet all requirements (if in excess of the above) of the specific third-party Practice Management Software (PMS) or Imaging Software if installed on the same PC.

Images are captured by the DC-Air™ sensor and transmitted in digital form wirelessly to the docking station and finally via USB connection for display, storage and printing on the PC using Archimed Suite imaging software. This software is brand labeled for Athlos Oy as DC-Air™ (or Athlos-1 or Athlos-Air) and has the same functionality as the software of the predicate device. Archimed Suite complies with the European Directive 93/42/EEC and is CE certified (1575/MMD) by IMQ 0051 Italy.

#### Indications for Use 5

DC-Air™, Athlos-1, Athlos-Air are intended to be used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw, and oral structures.

DC-Air™, Athlos-1, Athlos-Air are suitable for general populations.

#### Intended Use 6

DC-Air™, Athlos-1, Athlos-Air digital sensor systems are intended for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure.

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Image /page/6/Picture/0 description: The image shows the logo for Athlos. The logo features a stylized red figure of a person running or in motion, with geometric shapes behind them. To the right of the figure, the word "ATHLOS" is written in a bold, sans-serif font, also in red. There is a registered trademark symbol to the left of the figure.

DC-Air™, Athlos-1, Athlos-Air digital sensors are intended to capture an intraoral X-ray image, when exposed to X-rays, for dental diagnostic purposes.

#### Comparison of Technological Characteristics with Predicate 7

With respect to the 2D intraoral exposures, the proposed DC-Air™ digital sensor system utilizes a Si-CMOS (Direct Conversion) sensor, whereas the predicate QuickRay HD (K151926) utilizes a CMOS (scintillation) sensor. Additionally, DC-Air™ transmits the image via a Bluetooth transceiver, eliminating the wire between the sensor and the PC.

A "Direct Conversion" X-ray imaging sensor is an imaging device that converts X-ray energy directly to electrical signal charge. No intermediate conversion of X-rays to visible light photons is present in the imaging process as opposed to the predicate device which converts X-rays to light and light is converted then to electronic signal. There are several benefits of direct conversion in comparison to the indirect conversion of the predicate device. The sharpness of images produced by DC-Air™ (as quantified by the MTF) is a result of the minimal lateral spread of the signal charge during the image acquisition process. The predicate device first converts X-rays to light which exhibits a higher degree of image blur due to the spread of the visible photons in all directions within the converting scintillator material and inside the fiber optic plate. This spread can be several hundreds of micrometers. In DC-Air™ the X-ray induced signal electrons are driven by an electric field to the signal input node and collected in a very short time limiting lateral charge signal diffusion to a few tens of micrometers.

The principle and design of a direct conversion X-ray imaging sensor is shown and compared to a conventional scintillator-based sensor in the Figure below.

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Image /page/7/Picture/0 description: The image shows the logo for Athlos. The logo features a stylized red figure in motion, composed of geometric shapes, suggesting speed and athleticism. To the right of the figure is the word "ATHLOS" in a simple, sans-serif font.

Image /page/7/Figure/2 description: The image shows two diagrams, labeled a) and b), illustrating different detector configurations. Diagram a) depicts an X-ray interacting with a detector, creating a signal charge that spreads laterally across 10-30 um to an Application Specific Integrated circuit (ASI) with signal input nodes. Diagram b) shows an X-ray interacting with a scintillator, which emits visible photons that travel through fiber optics to an ASI, with a lateral signal spread of 200-300 um.

Figure 6-1: Comparison of (a) a direct DC-Air™ and (b) an indirect X-ray imaging sensor

In DC-Air™ (a) the X-rays are converted directly to charge in the Si semiconductor. The signal charge is driven by an electric field to the signal input node amplifier. A CMOS is connected to the Si detector and is used only as a readout to output the X-ray induced signals. In an indirect sensor (b) the X-rays are first converted to light in the bulk of the scintillator, i.e., visible photons which spread in all directions in the scintillator. The visible photons are then guided by a fiber optic plate to photodiodes, covering part of the pixels on the CMOS, which convert them to electrons. The signal charge is amplified and read out by an ASIC. Therefore, in the predicate device both the scintillator and the CMOS act as part of the detector. The CMOS has a fill factor which means that only a fraction of the pixel is sensitive to incoming light.

The directly converting DC-Air™ wireless intraoral sensor uses depleted crystalline silicon as the X-ray converting semiconductor detector material.

The subject device is using DC-Air™ (or Athlos-1 or Athlos-Air) imaging software which is the brand name for Athlos Oy of the software "Archimed Suite", a software produced by Digital Imaging. Archimed Suite complies with the European Directive 93/42/EEC and subsequent amendments and additions (CE certification 1575/MMD issued by IMQ 0051, Italy). The predicate uses third party software called Xray Vision which is manufactured by Apteryx in Akron, Ohio (K983111) cleared November 16, 1998.

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Image /page/8/Picture/0 description: The image shows the Athlos logo. The logo features a stylized red figure in motion, possibly representing an athlete. The word "ATHLOS" is written in bold, sans-serif font to the right of the figure.

| Feature: | Subject Device:<br>DC-Air | Predicate Device:<br>QuickRay HD | Equivalence: | Differences: |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>number: | Not assigned yet | K151926 | N/A1 | N/A |
| Regulation<br>number: | 21 CFR 872.1800 | 21 CFR 872.1800 | Same | None |
| Classification<br>and product<br>code: | Class 2, MUH | Class 2, MUH | Same | None |
| Indications for<br>use: | DC-Air™, Athlos-1, Athlos-Air<br>wireless digital sensors are<br>intended to be used for a<br>radiographic examination by a<br>dental professional to assist in<br>the diagnosing of diseases of<br>the teeth, jaw, and oral<br>structures. DC-Air™, Athlos-1,<br>Athlos-Air are suitable for<br>general populations. | QuickRay HD is used<br>for a radiographic<br>examination by a dental<br>professional to assist in<br>the diagnosing of<br>diseases of the teeth,<br>jaw and oral structures. | Same | None |
| Prescription/<br>over-the-<br>counter use: | Prescription use | Prescription use | Same | None |
| Size(s): | 1280mm² | Size 1: 600mm²<br>(pediatric use),<br>Size 2: 884mm²<br>(adults) | Similar | DC-Air comes in 1<br>size only (Size 2<br>intraoral x-ray<br>sensor) |
| Power supply: | Battery-powered | USB-powered<br>(connected to PC or<br>laptop) | Similar | DC-Air sensor is<br>wireless and thus,<br>battery-operated |
| Feature: | Subject Device:<br>DC-Air | Predicate Device:<br>QuickRay HD | Equivalence: | Differences: |
| Principles of<br>operation: | X-ray (radiation) >><br>Si Direct Conversion<br>(convert to electron-hole<br>pairs) >><br>CMOS (readout) >><br>Electronics (convert to<br>digital, capture &<br>wireless transmission)<br>>><br>PC (display image) | X-ray (radiation) >><br>Indirect Conversion<br>Scintillator (convert to<br>light) >><br>Fiber optic (filtering)<br>>><br>CMOS (convert to<br>electron hole pairs &<br>then readout)>><br>Electronics (convert to<br>digital, capture and<br>wired transmission) >><br>PC (display image) | Similar | DC-Air uses direct<br>conversion<br>technology |
| Software –<br>Image<br>Management | DC-Air (and Athlos-1<br>and Athlos-Air) Imaging<br>Software<br>(package from Digital<br>Imaging, Italy) | Xray Vision<br>(package<br>from Apteryx, USA) | Same | None |
| Operating<br>system<br>(PC/laptop) | Windows 7, 8, 8.1 and<br>10 | Windows Vista,<br>Windows XP,<br>Windows 7, 8, 8.1 and<br>10 | Similar | DC-Air PC<br>software is not for<br>use with Windows<br>Vista nor<br>Windows XP |
| Software –<br>Firmware: | Firmware combined on<br>sensor electronic board | Firmware combined on<br>sensor electronic board | Same | None |
| Sensor<br>technology: | CMOS chip (readout) +<br>Si Direct Conversion | CMOS chip (detection<br>of light + readout) +<br>Optical fiber plate +<br>CSi scintillator | Similar | DC-Air uses direct<br>conversion<br>technology |
| Matrix<br>dimensions<br>(mm²): | Active area:<br>866mm² | Active area:<br>Size 1: 600mm²,<br>Size 2: 884mm² | Similar<br>(size 2) | DC-Air comes in 1<br>size only (Size 2<br>intraoral x-ray<br>sensor) |
| Matrix<br>dimensions<br>(pixels): | 1350 x 950 | Size 1: 1000 lines X<br>1500 columns,<br>Size 2: 1300 X 1700 | Similar<br>(size 2) | DC-Air comes in 1<br>size only (Size 2<br>intraoral x-ray<br>sensor) |
| Feature: | Subject Device:<br>DC-Air | Predicate Device:<br>QuickRay HD | Equivalence: | Differences: |
| Lifespan<br>CMOS: | Min. 50,000 cycles | Min. 100,000 cycles | Similar | Lifespan of CMOS<br>used in DC-Air is<br>comparable to that<br>of the predicate's |
| Resolution: | Real ≥ 19pl/mm | Real ≥ 20pl/mm | Similar | Resolution of DC-<br>Air is comparable<br>to that of the<br>predicate device |
| Pixel size: | 26 * 26μm² | 20 * 20 μm² | Similar | Pixel size of DC-<br>Air is slightly<br>larger than that of<br>the predicate<br>device |
| MTF² @<br>2lp/mm | 85% | 60% | Similar | Sharpness of the<br>DC-Air is higher<br>than that of the<br>predicate device<br>on all diagnostic<br>line pair<br>frequencies |
| MTF @<br>5lp/mm | >70% | 30% - 45% | Similar | Sharpness of the<br>DC-Air is higher<br>than that of the<br>predicate device<br>on all diagnostic<br>line pair<br>frequencies |
| MTF @<br>10lp/mm | >40% | 8% - 25% | Similar | Sharpness of the<br>DC-Air is higher<br>than that of the<br>predicate device<br>on all diagnostic<br>line pair<br>frequencies |
| DQE: | DQE(0)=4.5% (RQA5)<br>DQE(5)=2.5 % (RQA5)<br>DQE(10)=1.5% (RQA5)<br>DQE(15)=1% (RQA5) | DQE(0)=45%<br>DQE(5)=20%<br>DQE(10)=5%<br>DQE(15)=1% | Similar | DQE of the DC-<br>Air is lower than<br>that of the<br>predicate |
| Feature: | Subject Device: | Predicate Device: | Equivalence: | Differences: |
| | DC-Air | QuickRay HD | | |
| Grey levels: | 12 bits | 14 bits | Similar | Digital scales of<br>DC-Air are less<br>than the predicate<br>device |
| Sensor board: | Part of control<br>electronics directly<br>integrated on CMOS<br>sensor chip.<br>ADC, triggering, and<br>memory integrated on<br>sensor board. | All control electronics<br>directly integrated on<br>CMOS sensor chip | Similar | ADC, triggering,<br>and memory of the<br>DC-Air are<br>integrated on the<br>sensor board.<br>Predicate does not<br>have on-board<br>memory. |
| Sensor shell: | Specific shape design.<br>Material is<br>Polyphensylsulfone,<br>flammability V-0 (UL<br>file No. E36098). | Specific shape design.<br>Material is ABS and<br>the flammability is HB<br>if YK-94 (UL File No.<br>49895). | Same | None |
| Sensor<br>housing: | IP67 protected<br>IP64 protected | IP67 protected | Same | None |
| Connection to<br>PC: | USB 2.0 (via docking<br>station) | USB 2.0 High-Speed | Same | None |
| Operating<br>temperature: | +10°C to 35°C | 0°C to 35°C | Same | None |
| Sensor input<br>voltage and<br>current: | 3.5 to 4.15 V (battery),<br>9.7 mA | 5V (via USB<br>connection),<br>0.15A Max | Similar | DC-Air sensor<br>uses lower voltage<br>and current |
| Standards of<br>conformity: | IEC 60601-1 (Electrical<br>safety)<br>IEC 60601-1-2 (EMC)<br>IEC 62220-1-1<br>(Performance)<br>IEC 60529 (IP Code) | IEC 60601-1<br>(Electrical)<br>IEC 60601-1-2 (EMC)<br>IEC 62220-1 (Performance)<br>IEC 60529 (IP Code) | Same | None |

Table 6-1: Similarities and differences between the new DC-Air and the predicate QuickRay HD

^!N/A = Not Applicable

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Image /page/9/Picture/0 description: The image contains the logo for Athlos. The logo features a stylized red figure of a person running, with geometric shapes suggesting motion. The word "ATHLOS" is written in bold, sans-serif font to the right of the figure.

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Image /page/10/Picture/0 description: The image contains the logo for Athlos. The logo features a stylized red figure in motion, possibly representing an athlete. The word "ATHLOS" is written in bold, sans-serif font to the right of the figure. There is a registered trademark symbol next to the logo.

² MTF = Modulation Transfer Function

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Image /page/11/Picture/0 description: The image is a logo for Athlos. The logo features a stylized red figure of a person running, with geometric shapes behind them. The word "ATHLOS" is written in bold, sans-serif font to the right of the figure.

#### Performance Data 8

X-ray images taken using the DC-Air™ were examined by doctors Robert Sachs D.D.S., John M. Steinberg D.D.S., and Steven R. Gluck D.D.S. and found to be diagnostically relevant and reliable.

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Image /page/12/Picture/0 description: The image shows the logo for Athlos. The logo consists of a stylized red figure that appears to be running or leaping, with geometric shapes suggesting motion or speed. The word "ATHLOS" is written in a simple, sans-serif font to the right of the figure. The logo is clean and modern, suggesting themes of athleticism, movement, and progress.

#### 9 Biocompatibility

Biocompatible testing for the subject device DC-Air™ is not warranted because there are no direct or indirect patient-contacting components in the device. DC-Air™ sensor is covered with a singleuse protective barrier prior to each use like its predicate QuickRay HD (K151926).

# 10 Electrical Safety and EMC

The subject device DC-Air™ has been tested for electrical safety and EMC.

The DC-Air™ sensor and docking station conform to electrical and safety standard IEC 60601-1 Medical Electrical Equipment - Part I: General requirements for basic safety and essential performance.

The DC-Air™ sensor and docking station conform to electrical and safety standard IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility.

The DC-Air™ sensor and docking station conform to regulation FCC CFR 47 Part 15 B.

# 11 Software Verification and Validation Testing

DC-Air™ sensor and docking station electronics contain firmware. Additionally, DC-Air™ uses imaging software provided by Digital Imaging, Italy. Therefore, only firmware documentation for the subject device is included in this submission.

# 12 Bench Testing

Bench tests for subject device DC-Air™ were performed in conformance with standard IEC 62220-1-1 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-1: Determination of the detective quantum efficiency - Detectors used in radiographic imaging and standard IEC 60529 Degrees of Protection Provided by Enclosures - IP Codes.

# 13 Conclusions

The subject DC-Air™ and its predicate device QuickRay HD (K151926) have the same intended use and similar technological features. DC-Air™ and QuickRay HD are similar in terms of operation and sensor technology and they use similar imaging software. QuickRay HD is connected to the PC via a USB cable. DC-Air™ sensor is intended for wireless operation. However, USB connection between the DC-Air™ sensor and the PC is enabled via DC-Air™ docking station.

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The conclusion is that the subject device DC-Air™ is as safe and effective as the predicate QuickRay HD and these devices are identical in structure and use. The software packages of the subject device and the predicate are different. The subject device PC software has been FDA cleared with other similar devices (DEEP View by Trident s.r.l. as part of K160386).

Athlos Oy believes that the subject device DC-Air™ and its predicate QuickRay HD are similar.