Who is the manufacturer of PAPAYA 3D Plus?

Genoray Co., Ltd. filed the 510(k) submission for PAPAYA 3D Plus (K150354).

What is the FDA product code for PAPAYA 3D Plus?

OAS. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for PAPAYA 3D Plus?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PAPAYA 3D Plus?

Hyperion X9 (K123381); PAPAYA Plus (K141700).

Who can help prepare an FDA 510(k) submission like PAPAYA 3D Plus?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PAPAYA 3D Plus

K150354 · Genoray Co., Ltd. · OAS · Dec 10, 2015 · Radiology

Device Facts

Record ID	K150354
Device Name	PAPAYA 3D Plus
Applicant	Genoray Co., Ltd.
Product Code	OAS · Radiology
Decision Date	Dec 10, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2

Intended Use

PAPAYA 3D Plus is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in: (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with the cephalometric arm; (iii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition(teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option. The system accomplishes tomographic exam by acquiring a 360-degree rotational X-ray sequence of images and reconstructing a three-dimensional matrix of the examined volumensional views of this volume and displaying both two dimensional images and three-dimensional renderings.

Device Story

Diagnostic imaging system for dental/craniofacial anatomy; acquires panoramic, cephalometric, and 3D CBCT images. Input: 360-degree rotational X-ray sequence via extra-oral X-ray tube and CMOS flat panel detectors. Transformation: Reconstruction of 3D matrix from rotational image sequences. Output: 2D images and 3D renderings displayed for clinician review. Used in dental clinics; operated by trained personnel. Output assists in treatment planning, implant placement, and diagnosis of impacted teeth or oral structures. Benefits: Provides dimensional information for precise surgical/treatment planning.

Clinical Evidence

Bench testing only. Performance evaluated via phantom studies (contrast scale, noise, slice thickness, resolution) and sensor testing (MTF, DQE, dynamic range). Compliance with IEC 60601-1, 60601-1-3, 60601-2-63, 60601-1-2, and 61223-3-4/5 standards confirmed. All results within standard ranges. No clinical patient data reported.

Technological Characteristics

Extra-oral X-ray system using CMOS flat panel detectors. Energy source: X-ray tube (60-90 kV, 4-12 mA). Focal spot: 0.5 mm. Connectivity: DICOM (NEMA PS 3.1-3.18) compliant. Safety standards: IEC 60601-1 series, 21 CFR 1020.30/31/33. Software: Triana image viewer (OTS).

Indications for Use

Indicated for diagnostic examination of dentition, jaws, oral structures, and cranial bones in patients requiring panoramic, cephalometric, or tomographic (CBCT) imaging of the maxillofacial area and skull.

Regulatory Classification

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

Hyperion X9 (K123381)
PAPAYA Plus (K141700)

Related Devices

K220392 — PAPAYA 3D & PAPAYA 3D Plus · Genoray Co., Ltd. · May 19, 2022
K130432 — PHT-6500, PHT-60CFO · VATECH Co., Ltd. · May 31, 2013
K220423 — PAPAYA & PAPAYA Plus · Genoray Co., Ltd. · May 19, 2022
K161900 — HYPERION X5 · Cefla S.C. · Dec 9, 2016
K200469 — PAPAYA 3D Premium & PAPAYA 3D Premium Plus · Genoray Co., Ltd. · Sep 16, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 10, 2015 GENORAY Co., Ltd. % Ms Kaitlynn Min Business Developer Manager GENORAY America, Inc. 3002 Dow Avenue, Suite 420 TUSTIN CA 92780 Re: K150354 Trade/Device Name: PAPAYA 3D Plus Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS, MUH Dated: November 17, 2015 Received: November 18, 2015 Dear Ms. Min: 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Robert Ocklo Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K150354 Device Name PAPAYA 3D Plus Indications for Use (Describe) PAPAYA 3D Plus is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in: - (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and - (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with the cephalometric arm; - (ii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition(teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option. The system accomplishes tomographic exam by acquiring a 360-degree rotational X-ray sequence of images and reconstructing a three-dimensional matrix of the examined volumensional views of this volume and displaying both two dimensional images and three-dimensional renderings. | 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) | | | | | 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: | | | | | | Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov | Department of Health and Human Services | | | | | information unless it displays a currently valid OMB number." | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of | | | | Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ #### Exhibit 5 510(k) Summary Date of Summary Preparation: Feb 01, 2015 - 1. Submitter and US Official Correspondent Submitter: GENORAY Co., Ltd. Address: #512, Byucksan Technopia 434-6, Sangdaewon 1-dong, Jungwon-gu, Seongnam-city Gyeonggi-do, 462-716, Korea Telephone No.: +82-31-740-4100 Fax: +82-31-737-8025 Official Correspondent (U.S): Kaitlynn Min - Business Manager Correspondent: GENORAY America Inc. Address: 3002 Dow Avenue, Suite 420, Tustin, CA 92780 Telephone No.: 714-289-8020 Fax: 714-786-8919 Email: kaitlynn@genorayamerica.com - 2. Establishment Registration Number 3005843418 - 3. Device Information Trade/Device Name: PAPAYA 3D Plus Regulation Name: Computed tomography X-ray System Classification Name/Product Code: X-ray, Tomography, Computed/OAS System, X-ray, Extraoral Source, Digital / MUH Device Class: Class II per regulation 21 CFR 892.1750 - 4. Predicate Device (Equivalent Legally Marketed Device) Hyperion X9 (K123381, Cefla S.C.) PAPAYA Plus (K141700 Genoray Co., Ltd) - ર. Description of the Device PAPAYA 3D Plus is a diagnostic imaging system which consists of multiple image acquisition modes; panorama, cephalometric, and computed tomography. PAPAYA 3D Plus designed for dental radiography of the oral and craniofacial anatomy such as teeth, jaws and oral structures. PAPAYA 3D Plus is equipped with extra-oral flat panel x-ray detectors which is based on CMOS digital X-ray detector and has CT, panoramic and cephalometric radiography with an extra-oral x-ray tube. CMOS Flat panel detectors are used to capture scanned image for obtaining diagnostic information for craniofacial surgery or other treatments. And it also provides 3D diagnostic images of the anatomic structures by acquiring 360°rotational image sequences of oral and craniofacial area. {4}------------------------------------------------ #### Indications for use (intended use) 6. PAPAYA 3D Plus is a digital panoramic, cephalometric and tomographic extra-oral Xray system, indicated for use in: - (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and - (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with the cephalometric arm; - (iii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition(teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option. The system accomplishes tomographic exam by acquiring a 360-degree rotational Xray sequence of images and reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two dimensional images and three-dimensional renderings. | Name | Proposed device PAPAYA 3D Plus | Hyperion X9 | PAPAYA Plus | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufactur er | GENORAY Co., Ltd. | CEFLA S.C. | GENORAY Co., Ltd. | | 510(k) No. | - | K123381 | K141700 | | Indications for use | PAPAYA 3D Plus is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in: (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with the cephalometric arm; (iii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition(teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option. The system accomplishes tomographic exam by acquiring a 360-degree rotational X-ray sequence of images and reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two dimensional images and three- dimensional renderings. | Hyperion X9 is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in: (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with tele-radiographic arm (CEPH); (iii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition (teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option. The system accomplishes tomographic exam by acquiring a 360-degree rotational X-ray sequence of images and reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two dimensional images and three- dimensional renderings. | PAP A Y A Plus is a digital extraoral source X-ray system intended to produce panoramic and cephalometric(option) images of the oral and craniofacial anatomy for a precise treatment planning in adult and pediatric care. The system is used for dental & skull radiographic examination and diagnosis ofteeth,jaw, oral structure, and skull by exposing an X-ray image receptor to ionizing radiation, with a digital imaging capability for taking both panoramic and cephalometric images. And this system can be equipped CUST(Tomographic) option, which is capable of taking cross-sectional radiographic images. These images provide dimensional information for dental implant planning and information about location of impacted teeth | #### 7. Substantial equivalence chart {5}------------------------------------------------ | Name | Proposed device PAPAYA 3D Plus | Hyperion X9 | PAPAYA Plus | |----------------------------------|------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------| | Performance Specificatio n | Panoramic Cephalometric Computed tomography | Panoramic Cephalometric Computed tomography | Panoramic Cephalometric Tomography | | 3D Technology | Cone beam Computed tomography | Cone beam Computed tomography | Volumetric tomography | | CT FOV (D×H) | 14×14, 14×8, 8×8, 7×7, 4×4cm | 11×8, 11×5, 8×8, 8×5, 5×5cm | 4.8×10 | | Input Voltage | 100-120V~ | 115 - 240 V~ | 100-120V~ | | Tube Voltage | 60-90 kV | 60-90 kV | 60-90 kV | | Tube Current | 4-12 mA | 1-10 mA | 4-12 mA | | Focal Spot Size | 0.5 mm | 0.5 mm | 0.5 mm | | Exposure Time | PANORAMA: max 17sec CEPHALO: max 12sec CT : max15sec | 160ms - 18 sec | Standard Panorama: 12 sec Cephalo(Normal): 8 sec | | Image Receptor | Panoramic: CMOS FPD Cephalometric: CMOS FPD CBCT: CMOS FPD | Panoramic: CCD Cephalometric: CCD CBCT: Amorphous Silicon FPD | Panoramic: CMOS FPD Cephalometric: CMOS FPD | The proposed PAPAYA 3D Plus was developed from the PAPAYA Plus(k141700) by adding Computed tomography function. Accordingly, the characteristics of the PAPAYA 3D Plus are identical or similar to those of the PAPAYA Plus(k141700) regarding X-ray generation device characteristics including tube voltage, tube current, focal spot size and X-ray image capturing device including type of detector. The differences of the PAPAYA 3D Plus from the PAPAYA Plus(k141700) are the addition of detector options and Computed tomography function. New SSXI detectors are Extor-P for Panorammic mode, Extor-C for Cephalo mode, and DualRay-S for CBCT mode. They are for the newly upgraded PAPAYA Plus(k141700). Remaining detectors are the same, the non-clinical considerations are also equivalent, and the report regarding non-clinical & clinical consideration for the added new detectors are provided separately. The Computed tomography function of the PAPAYA 3D Plus is similar to Hyperion X9(k123381). The system accomplishes tomographic exam by acquiring a 360-degree rotational X-ray sequence of images and reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two dimensional images and three-dimensional renderings. It is known as CBCT. The PAPAYA 3D Plus has the similar characteristics regarding intended use, X-ray generation device characteristics including tube voltage, tube current, and focal spot size as Hyperion X9(k123381). The PAPAYA 3D Plus has the same indication for use as the Hyperion X9(k123381). {6}------------------------------------------------ ### 8. Safety, EMC and Performance data comparison to Predicate PAPAYA 3D Plus complies with industry standards such as IEC 60601-1 Series and 21 CFR 1020.30 and 21 CFR 1020.31 and 21 CFR 1020.33 to minimize electrical, mechanical and radiation hazards. - Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-3, and IEC 60601-2-63 were performed. - EMC testing was conducted in accordance with standard IEC 60601-1-2. - Acceptance test according to standard IEC 61223-3-4 and IEC 61223-3-5 were performed. । - FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging । Devices" was performed for each new detector of PAPAYA 3D Plus. The existing detector test results are as follows. The tests include the MTF, DQE and the dynamic range of the panoramic sensor and the cephalometric sensor. Both the MTF of the two detectors shows the resolution more than 80% at 21p / mm and the DQE of them shows the performance of about 80% at 01p / mm. The dynamic range of them shows more than 72dB. And, the additional detector test results are as follows. The tests include the MTF, DQE and the dynamic range of the panoramic sensor, the cephalometric sensor and the CT sensor. The MTF of the new detectors shows the resolution more than 60% at 11p / mm and the DQE of them shows the performance of about 70% at 01p / mm. The dynamic range of them shows more than 72dB. Based on the Non-Clinical Test results, even though the pixel size and active area of the new SSXI detectors are different, the diagnostic image quality of new sensors is similar to that of the predicate device and there is no significant difference in efficiency and safety. Please refer to Attachment X. Solid State X-ray imaging Device. And 3D performance tests with phantoms were performed. Test items are contrast scale, noise, slice thickness, and resolutions. All test results were within standard value range. - PAPAYA 3D Plus meets the EPRC standards (21 CFR 1020.30. 31. 33) - PAPAYA 3D Plus also meets the provisions of NEMA PS 3.1-3.18. Digital Imaging and - Communications in Medicine (DICOM) Set. - PAPAYA 3D Plus uses OTS software, Triana as an image viewer. Software validation report was conducted as recommended by FDA's Guidance document "Guidance for off-the-shelf Software Use in Medical Devices" The OTS Software, Triana in PAPAYA 3D Plus represents a Minor Level of Concern since failures or latent design flaws would not be expected to result in any injury to the patient or operator. - PAPAYA 3D Plus was tested for safety and effectiveness related in Clinical Evaluation i report. All test results were satisfactory. The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices. {7}------------------------------------------------ ## 9. Conclusion In reference to the comparison information provided in substantial equivalence chart, most of functions and electronic features are similar with predicate devices. We believe that the PAPAYA 3D Plus is safe and effective as predicate devices, and has no new indication for use. Thus PAPAYA 3D Plus is substantially equivalent to predicate devices.