← Product Code [OAS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OAS) · K203784 # PreXion3D Explorer PRO (K203784) _Prexion Corporation · OAS · Feb 23, 2021 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OAS/K203784 ## Device Facts - **Applicant:** Prexion Corporation - **Product Code:** [OAS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OAS.md) - **Decision Date:** Feb 23, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1750 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Pediatric ## Intended Use PreXion3D Explorer PRO is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment. ## Device Story Device is a computed tomography X-ray system for dental, oral, maxillofacial, ENT, and neck imaging. Input: X-ray absorption data acquired by rotating arm with X-ray generator and flat panel detector around patient head. Operation: High-voltage transformer boosts voltage to X-ray tube; tube generates X-rays; detector captures absorption data. Console performs image reconstruction (filtered-back-projection for CT/Panoramic) and analysis (2D/3D, cross-sections). Output: 2D/3D digital X-ray images for diagnostic support. Used in clinical settings by healthcare professionals. Benefits: Provides diagnostic imaging for treatment planning and growth assessment. Safety features: Hardware timer, exposure buzzer, emergency switch. ## Clinical Evidence No clinical data. Substantial equivalence supported by non-clinical performance testing, including biocompatibility (ISO 10993), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and software verification/validation (IEC 62304). ## Technological Characteristics Computed tomography X-ray system. Materials: Polycarbonate (chin rest), silicone rubber (forehead holder/handle grip). Energy: X-ray generator (90-110kV, 1-5.3mA). Detector: Flat panel detector (FPD/TFT). Connectivity: DICOM standard. Software: Filtered-back-projection reconstruction. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 62366, IEC 62304, ISO 14971, ISO 10993. ## Regulatory Identification A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. ## Predicate Devices - PreXion3D Explorer EX ([K193329](/device/K193329.md)) - PreXion3D Explorer ([K190320](/device/K190320.md)) ## Related Devices - [K161900](/device/K161900.md) — HYPERION X5 · Cefla S.C. · Dec 9, 2016 - [K232166](/device/K232166.md) — PreXion3D Expedition · Prexion Corporation · Sep 8, 2023 - [K150354](/device/K150354.md) — PAPAYA 3D Plus · Genoray Co., Ltd. · Dec 10, 2015 - [K240855](/device/K240855.md) — Dental Cone-beam Computed Tomography · Yian Medical Technology (Haining) Co., Ltd. · Apr 25, 2024 - [K220392](/device/K220392.md) — PAPAYA 3D & PAPAYA 3D Plus · Genoray Co., Ltd. · May 19, 2022 ## Submission Summary (Full Text) {0}------------------------------------------------ February 23, 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. PreXion Corporation % Mr. Hiroaki Takahashi General Manager 1-14-1 Kandasuda-cho Chiyoda-ku. Tokyo 101-0041 JAPAN Re: K203784 Trade/Device Name: PreXion3D Explorer PRO Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: December 23, 2020 Received: December 28, 2020 Dear Mr. Takahashi: 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 {1}------------------------------------------------ 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 (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) K203784 Device Name PreXion3D Explorer PRO #### Indications for Use (Describe) PreXion3D Explorer PRO is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment. Type of Use (Select one or both, as applicable) | <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Prexion. The logo features the company name in a light gray, sans-serif font, with the "IT" in "make IT visible" in blue. Above the company name is a blue and white swoosh design, adding a modern and dynamic element to the logo. # 510(k) Summary # PreXion3D Explorer PRO # K203784 ## 1. Submission Sponsor PreXion Corporation 1-14-1, Kandasuda-cho, Chiyoda-ku, Tokyo 101-0041 Japan Hiroaki Takahashi General Manager, Quality Assurance & Regulatory Division Email: px-ra@prexion.co.jp Office number: +81-3-5297-7037 ## 2. Submission Correspondent Same as above ## 3. Date Prepared December 23th, 2020 #### 4. Device Identification | Trade/Proprietary Name: | PreXion3D Explorer PRO | |-------------------------|---------------------------------------| | Common/Usual Name: | OAS: Computed Tomography X-Ray System | | Regulation Number: | OAS: 21 CFR 892.1750 | | Product Code: | OAS | | Device Class: | Class II | | Classification Panel: | Radiology | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Prexion. The word "Prexion" is written in a gray sans-serif font. Below the word "Prexion" is the phrase "make IT visible" in a smaller font. Above and to the right of the word "Prexion" is a blue swoosh design. #### 5. Legally Marketed Predicate Device(s) Predicate Device (Primary) : K193329, PreXion3D Explorer EX, PreXion Corporation Predicate Device (Seconday) : K190320, PreXion3D Explorer, PreXion Corporation #### 6. Indication for Use Statement PreXion3D Explorer PRO is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment. #### 7. Device Description PreXion3D Explorer PRO consists of a scanner, which is used for generating X-ray and detecting image data, and a console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Explore Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating crosssection diagram, etc.), and output the image to a printer. X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, CT-Panoramic scan) and Cephalometric Scan. The operating principle of the device is as follows. <X-ray generation principle> X-rays are generated by the conversion of electron kinetic energy. Part of the kinetic energy which is generated when electrons moving at high speed are decelerated inside matter becomes the conversion source. Use a high-voltage transformer to boost the commercial voltage (100 to 240 V) to direct current high voltage (several tens of kV) and apply it to the X-ray tube to accelerate the X-ray tube's thermal electrons, and then the X-ray will be generated. The change in the voltage (tube voltage) and current (tube current) applied to the X-ray tube brings the following features. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Prexion. The word "Prexion" is written in a light gray, serif font. Below it, in a smaller, red sans-serif font, is the phrase "make IT visible". To the right of the text is a curved, blue graphic that resembles a swoosh or an abstract eye. - The higher the X-ray tube voltage is, the qreater the penetration strength of X-rays is. - The higher the current (tube current) is, the more the X-ray dose is. With the consideration of the above features, X-ray devices are designed to be able to control the X-ray dose and strength according to the intended use. <CT Scan principle and Panoramic Scan principle> X-ray photography is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan) and the tomographic image (CT scan, Panoramic scan). #### Cephalometric Exposure . Based on cephalometric radiography, a plain radiographic image of the properly positioned "patient's head" between X-ray generator and flat panel detector with stable magnification ratio, can be acquired. Also, the image of "patient's hand" can be obtained. #### <Software> PreXion3D Explorer PRO consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Explorer PRO Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer. X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, CT-Panoramic scan) and Cephalometric Scan. For CT and Panoramic scan, the detected data is reconstructed using filterd-back-projection method. In the case of Cephalometric scan, the acquired 2D data is output as it is. The software is unchanged from the predicates in terms of function. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Prexion, a company that appears to be in the IT sector. The logo features the company name in a stylized font, with the "Pre" portion in a light gray color and the "xion" portion in a darker gray. Below the company name is the tagline "make IT visible" in a smaller font. A blue swoosh design arches over the company name, adding a modern and dynamic element to the logo. #### Software Level of Concern - The software level of concern for the PreXion3D Explorer PRO is Moderate. The rationale is as follows: Even prior to mitigation of hazards, there is no risk of serious injury or death associated with this software. Excessive X-ray irradiation can be considered as a risk of serious injury, but it is limited in scope by a hardware timer. A hardware activated buzzer indicating exposure and an emergency switch are also provided. As such, there is a risk of injury associated with the software, but not serious injury. #### 8. Substantial Equivalence Discussion The following table compares the PreXion3D Explorer PRO to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device. | | Subject Device | Predicate Device<br>(Primary) | Predicate Device<br>(Secondary) | | | |--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | Manufacturer | PreXion Corporation | PreXion Corporation | PreXion Corporation | Comparison to Predicate | | | Trade Name | PreXion3D Explorer PRO | PreXion3D Explorer EX | PreXion3D Explorer | | | | 510(k) Number | TBD | K193329 | K190320 | N/A | | | Product Code | OAS | Same | Same | Same | | | Regulation Number | OAS: 21 CFR 892.1750 | Same | Same | Same | | | Regulation Name | OAS: Computed tomography x-ray system | Same | Same | Same | | | Device Classification<br>Name | X-Ray, Tomography, Computed, Dental | Same | Same | Same | | | | PreXion3D Explorer<br>PRO is intended to<br>produce two<br>dimensional digital<br>panoramic and<br>cephalometric<br>images, and three-<br>dimensional digital x-<br>ray images of the<br>maxillofacial, and<br>ENT (Ear, Nose and<br>Throat) region at the<br>direction of<br>healthcare<br>professionals as<br>diagnostic support for<br>adult and pediatric<br>patients.<br>Cephalometric<br>imaging also includes<br>the hand and wrist to | PreXion3D Explorer<br>EX is intended to<br>produce two<br>dimensional digital<br>panoramic and<br>cephalometric<br>images, and three-<br>dimensional digital<br>x-ray images of the<br>maxillofacial, and<br>ENT (Ear, Nose and<br>Throat) region at<br>the direction of<br>healthcare<br>professionals as<br>diagnostic support<br>for adult and<br>pediatric patients. | PreXion3D Explorer is<br>intended to produce<br>two-dimensional<br>digital x-ray images<br>including panoramic<br>and cephalometric<br>image, and three-<br>dimensional digital x-<br>ray images of the<br>dental, oral,<br>maxillofacial<br>region,ENT (Ear,<br>Nose and Throat)<br>and neck region at<br>the direction of<br>healthcare<br>professionals as<br>diagnostic support for<br>adult and pediatric | | | | Indications for use: | obtain carpus images<br>for growth and<br>maturity assessment.<br>This device is not<br>intended for use on<br>patients less than<br>approximately 21 kg<br>(46 lb) in weight and<br>113 cm (44.5 in) in<br>height; these height<br>and weight<br>measurements<br>approximately<br>correspond to that of<br>an average 5 year-<br>old. Use of<br>equipment and<br>exposure settings<br>designed for adults of<br>average size can<br>result in excessive<br>radiation exposure<br>for a smaller patient.<br>Studies have shown<br>that pediatric<br>patients may be<br>more radiosensitive<br>than<br>adults (i.e., the<br>cancer risk per unit<br>dose of ionizing | This device is not<br>intended for use on<br>patients less than<br>approximately 21<br>kg (46 lb) in weight<br>and 113 cm (44.5<br>in) in height; these<br>height and weight<br>measurements<br>approximately<br>correspond to that<br>of an average 5<br>year-old. Use of<br>equipment and<br>exposure settings<br>designed for adults<br>of average size can<br>result in excessive<br>radiation exposure<br>for a smaller<br>patient. Studies<br>have shown that<br>pediatric patients<br>may be more<br>radiosensitive than<br>adults (i.e., the<br>cancer risk per unit<br>dose of ionizing | patients.<br>Cephalometric<br>imaging also includes<br>the hand and wrist to<br>obtain carpus images<br>for growth and<br>maturity assessment. | Similar | | | radiation is higher),<br>and so unnecessary<br>radiation exposure is<br>of particular concern<br>for pediatric patients. | | | radiation is higher),<br>and so unnecessary<br>radiation exposure<br>is of particular<br>concern for<br>pediatric patients. | | | | Patient/User Characteristics | | | | | | | Target Population | | Children aged 6<br>(except infants) to<br>elderly | Same | Same | Same | | Anatomical Site | | The dental, oral,<br>maxillofacial region<br>ENT (Ear, Nose and<br>Throat) and neck<br>region | Same | Same | Same | | Users | | Health care<br>professionals | Same | Same | Same | | Technological Characteristics and Performance | | | | | | | Patient Contact<br>Material | | CHIN REST:<br>polycarbonate<br>Forehead Holder:<br>silicone rubber<br>HANDLE GRIP:<br>silicone rubber | Same | CHIN REST:<br>polycarbonate<br>HEADREST: carbon<br>BELT: polyvinyl<br>chloride | Biocompatibili<br>ty test results<br>support that<br>the material<br>is safe for the<br>intended use. | | Sterility | | Non-sterile | Same | Same | Same | | | Tube<br>Voltage | 90-110KV | 90-110KV | 90-110KV | Same | | X-ray<br>Generati | Pulse<br>Exposure<br>function | Yes | Yes | Yes | Same | | on<br>Device | Tube<br>Current | 1-5.3mA | 1-5mA | 1-5mA | Same | | | Focal<br>Spot Size | 0.3mm x 0.3mm | Same | Same | Same | | | Detector | FPD (TFT) | Same | Same | Same | | X-ray<br>Image<br>Capturin<br>g Device | Pixel<br>Size | 248 $μ$ m x248 $μ$ m<br>(With binning)<br>(CT, CT-Panoramic, | 248 $μ$ m x248 $μ$ m<br>(With binning)<br>(CT, CT-Panoramic, | Same | Same as<br>secondary<br>predicate<br>device | | | | 124 μm x124μm<br>(Without binning)<br>(CT, CT-Panoramic,<br>Panoramic, Ceph) | 124 μm x124µm<br>(Without binning)<br>(CT, CT-Panoramic,<br>Panoramic)<br>*No Ceph Function | | | | | | 1024x1280(With<br>binning)<br>(CT, CT-Panoramic) | 1024x1280(With<br>binning)<br>(CT, CT-Panoramic) | 1024x1280(With<br>binning)<br>(CT, CT-Panoramic) | Regarding<br>СТ, СТ-<br>Panoramic,<br>all same | | | Pixel<br>Number | 2560x2048(Without<br>binning)<br>(CT, CT-Panoramic,<br>Ceph) | 2560x2048(Without<br>binning)<br>(CT, CT-Panoramic)<br>*No Ceph Function | 2560x2048(Without<br>binning)<br>(CT, CT-Panoramic,<br>Ceph) | Regarding<br>Ceph, same<br>as secondary<br>predicate<br>device | | | | 1900 x 120<br>(Panoramic) | 1900 x 120<br>(Panoramic)<br>*No Ceph Function | *No Panoramic<br>Function | Regarding<br>Panoramic<br>same as<br>primary<br>predicate | | | | 2112x1754<br>(Cephalometric) | | | device | | | | 253.95mm x<br>317.44mm<br>(CT, CT-Panoramic) | 253.95mm x<br>317.44mm<br>(CT, CT-Panoramic) | 253.95mm x<br>317.44mm<br>(CT, CT-Panoramic) | Regarding<br>СТ, СТ-<br>Panoramic,<br>all same. | | | Size of<br>Area<br>Receivin<br>g X-ray | 230mm x 15mm<br>(Panoramic) | 230mm x 15mm<br>(Panoramic) | *No Panoramic<br>Function | Regarding<br>Panoramic<br>same as<br>primary<br>predicate<br>device | | | | 253.95mm x<br>317.44mm (Ceph) | *No Ceph Function | 253.95mm x<br>317.44mm (Ceph) | Regarding<br>Ceph, same<br>as secondary<br>predicate<br>device | | |… --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OAS/K203784](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OAS/K203784) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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