(120 days)
No
The document describes a standard mobile fluoroscopy system and does not mention AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is described as a mobile fluoroscopy system designed to provide fluoroscopic and spot film images for diagnostic, surgical, and interventional procedures, indicating its primary function is imaging and visualization rather than direct therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures." The "Device Description" also mentions its use for "providing fluoroscopic and radiographic images of patient anatomy."
No
The device description explicitly states that the system consists of hardware components including an X-ray tube assembly, X-ray controller, and Image receptor. It is a mobile fluoroscopy system, which is a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide fluoroscopic and spot film images of the patient during diagnostic, surgical, and interventional procedures. This involves imaging the patient's anatomy directly using X-rays.
- Device Description: The device is described as a mobile fluoroscopy system that visualizes anatomical structures by converting X-radiation into a visible image. It consists of components like an X-ray tube assembly and image receptor.
- Nature of IVDs: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside of the body to obtain information about a patient's health.
This device is clearly an imaging device used in vivo (within the living body) to visualize internal structures, not an IVD used to analyze samples in vitro.
N/A
Intended Use / Indications for Use
OSCAR 15 & OSCAR 15i are a mobile fluoroscopy system designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, neurologic, vascular, cardiac and critical care. The system may be used for other imaging applications at the physician's discretion. OSCAR 15i are indicated only for adult patients.
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA
Device Description
The OSCAR 15 & OSCAR 15i, C-Arm Mobile are used for providing fluoroscopic and radiographic images of patient anatomy, especially during special procedures in a hospital or medical clinics. The fluoroscopic mode of operation is very useful to the attending physician to see the images on real time without the need to develop individual films. These devices are intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification.
The OSCAR 15 & OSCAR 15i consist of the X-ray tube assembly, X-ray controller, Image receptor and some accessories with no wireless function. The difference between OSCAR 15 and OSCAR 15i is only image acquisition parts. (An Flat Panel Detector (FPD) is applied to OSCAR 15, and an Image instensifier is applied to OSCAR 15i.)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Hospital or medical clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical validation testing has been performed to validate that OSCAR 15 & OSACR 15i conform to the intended use, claims, user needs, effectiveness of safety measures and instructions for use.
The image performance was evaluated according to the IEC standard through performance bench testing demonstrated that these differences do not tailor effectiveness in comparison with the predicate device. Furthermore, clinical images have been evaluated by a licensed radiologist confirmed the sufficient diagnostic quality to provide accurate information.
Results demonstrated that all executed verification tests were passed.
As a results, all test results were satisfactory and the result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Previously cleared under K211780.
Previously cleared under K180473.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
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.(b)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.
July 20, 2023
Genoray Co., Ltd. % Kaitlynn Min Business Development Genoray America Inc. 147 E. Bristol Lane ORANGE, CA 92865
Re: K230787
Trade/Device Name: Oscar 15 & Oscar 15i Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA Dated: May 22, 2023 Received: July 3, 2023
Dear Kaitlynn 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. 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
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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 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 (OS) 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radialogical Imaging Devices and Electronic Products OHT8: Office of 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
510(k) Number (if known) K230787
Device Name OSCAR 15 & OSCAR 15i
Indications for Use (Describe)
OSCAR 15 & OSCAR 15i are a mobile fluoroscopy system designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, neurologic, vascular, cardiac and critical care. The system may be used for other imaging applications at the physician's discretion. OSCAR 15i are indicated only for adult patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Exhibit 5 510(k) Summary
This 510(k) summary information is prepared in accordance with 21 CFR 807.92
- Date of Summary Preparation [21 CFR 807.92(a) (1)] 1.
: Mar. 08, 2023
2. Administrative Information [21 CFR 807.92(a) (1)]
| 510(k) Submitter | GENORAY Co.,Ltd
Address: 512, 560, Dunchon-daero, Jungwon-gu,
Seongnam-si, Gyeonggi-Do, Korea
Telephone No.: +82-31-5178-5771
Fax: +82-31-5178-5599
Contact Person: JiYeon Choi(jychoi@genoray.com) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent | GENORAY America Inc.
Address: 147 E. Bristol Lane, Orange, CA 92865 USA
Telephone No.: +1-855-436-6729
Fax: +1-714-786-8919
Contact Person: Kaitlynn Min (kaitlynn@genorayamerica.com) |
3. Device Information [21 CRF 807.92(a) (2)]
| Trade / Device Name: | OSCAR 15 & OSACR 15i |
|---|---|
| Common or Usual Name: | Fluoroscopic X-ray System |
| Classification Name: | Interventional Fluoroscopic X-ray System |
| Classification Regulation: | 21 CFR 892.1650 |
| Class of Device: | Class II |
| Panel: | Radiology |
| Product Code: | OWB / Interventional Fluoroscopic X-Ray System |
| Subsequence product code: | JAA / System, X-Ray, Fluoroscopic, Image-Intensified |
Predicate Device Information [21 CRF 807.92(a) (3)] 4.
| Manufacturer: | GENORAY Co., Ltd |
|---|---|
| Name of Device: | OSCAR 15 (K172180) |
| Common or Usual Name: | Fluoroscopic X-ray System |
| Classification Name: | Interventional Fluoroscopic X-ray System |
| Classification Regulation: | 21 CFR 892.1650 |
| Class of Device: | Class II |
| Panel: | Radiology |
| Product Code: | OWB / Interventional Fluoroscopic X-Ray System |
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Subsequence product code: JAA / System, X-Ray, Fluoroscopic, Image-Intensified
5. Description of the Device [21 CRF 807.92(a) (4)]
The OSCAR 15 & OSCAR 15i, C-Arm Mobile are used for providing fluoroscopic and radiographic images of patient anatomy, especially during special procedures in a hospital or medical clinics. The fluoroscopic mode of operation is very useful to the attending physician to see the images on real time without the need to develop individual films. These devices are intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification.
The OSCAR 15 & OSCAR 15i consist of the X-ray tube assembly, X-ray controller, Image receptor and some accessories with no wireless function. The difference between OSCAR 15 and OSCAR 15i is only image acquisition parts. (An Flat Panel Detector (FPD) is applied to OSCAR 15, and an Image instensifier is applied to OSCAR 15i.)
Indications for use (intended use) [21 CRF 807.92(a) (5)] 6.
OSCAR 15 & OSCAR 15i are a mobile fluoroscopy system designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac and critical care. The system may be used for other imaging applications at the physician's discretion. OSCAR 15 and OSCAR 15i are indicated only for adult patients.
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7. Substantial equivalence chart [21 CRF 807.92(a) (6)]
| Proposed device | Predicate device | ||
|---|---|---|---|
| OSCAR 15 | OSCAR 15i | OSCAR 15 | |
| Manufacturer | GENORAY Co., Ltd. | GENORAY Co., Ltd. | GENORAY Co., Ltd. |
| 510(k) No. | - | - | K172180 |
| Classification | |||
| Name | Interventional Fluoroscopic X-Ray System | Interventional Fluoroscopic | |
| X-Ray System | |||
| Image: OSCAR 15 | Image: OSCAR 15i | Image: OSCAR 15 | |
| Proposed device | Predicate device | ||
| OSCAR 15 | OSCAR 15i | OSCAR 15 | |
| Indications | |||
| for use | OSCAR 15 & OSCAR 15i are a mobile fluoroscopy system designed to provide | ||
| fluoroscopic and spot film images of the patient during diagnostic, surgical and | |||
| interventional procedures. Examples of clinical application may include cholangiography, | |||
| endoscopy, urologic, orthopedic, neurologic, vascular, cardiac and critical care. The system | |||
| may be used for other imaging applications at the physician's discretion. OSCAR 15 and | |||
| OSCAR 15i are indicated only for adult patients. | OSCAR 15 & OSCAR 15i are a mobile fluoroscopy system designed to provide | ||
| fluoroscopic and spot film images of the patient during diagnostic, surgical and | |||
| interventional procedures. Examples of clinical application may include cholangiography, | |||
| endoscopy, urologic, orthopedic, neurologic, vascular, cardiac and critical care. The system | |||
| may be used for other imaging applications at the physician's discretion. OSCAR 15 and | |||
| OSCAR 15i are indicated only for adult patients. | OSCAR 15 is a mobile fluoroscopy system | ||
| designed to provide fluoroscopic and spot | |||
| film images of the patient during | |||
| diagnostic, surgical and interventional | |||
| procedures. Examples of clinical | |||
| application may include cholangiography, | |||
| endoscopy, urologic, orthopedic, | |||
| neurologic, vascular, cardiac and criticalcare. The system may be used for other | |||
| imaging applications at the physician's | |||
| discretion.. | |||
| Max. output | |||
| power | 15 kW | 15 kW | 15 kW |
| X-ray Tube | Rotating tube | Rotating tube | Rotating tube |
| Large : 0.6 mm | |||
| Small : 0.3 mm | Large : 0.6 mm | ||
| Small : 0.3 mm | Large : 0.6 mm | ||
| Small : 0.3 mm | |||
| High Frequency Inverter | High Frequency Inverter | High Frequency Inverter | |
| Proposed device | Predicate device | ||
| OSCAR 15 | OSCAR 15i | OSCAR 15 | |
| [Radiography] | [Radiography] | [Radiography] | |
| • Output kV, mAs | |||
| : 120kV @ 100mAs (max.) | • Output kV, mAs | ||
| : 120kV @ 100mAs (max.) | • Output kV, mAs | ||
| : 120kV @ 100mAs (max.) | |||
| • kV range | |||
| : 40kV ~ 120kV, Step: 1kV | • kV range | ||
| : 40kV ~ 120kV, Step: 1kV | • kV range | ||
| : 40kV ~ 120kV, Step: 1kV | |||
| • mAs range | |||
| : 0.4mAs ~ 100mAs, 24 Steps | |||
| (Snapshot: 1.0mA ~ 50.0mA) | • mAs range | ||
| : 0.4mAs ~ 100mAs, 24 Steps | |||
| (Snapshot: 1.0mA ~ 50.0mA) | • mAs range | ||
| : 0.4mAs ~ 100mAs, 24 Steps | |||
| Generator | [Fluoroscopy] | [Fluoroscopy] | [Fluoroscopy] |
| • Output kV, mA | |||
| : 120kV, 4mA (max.) | • Output kV, mA | ||
| : 120kV, 4mA (max.) | • Output kV, mA | ||
| : 120kV, 4mA (max.) | |||
| • kV range | |||
| : 40kV ~ 120kV, step: 1kV | • kV range | ||
| : 40kV ~ 120kV, step: 1kV | • kV range | ||
| : 40kV ~ 120kV, step: 1kV | |||
| • mA range |
- Small focus :
0.2mA ~ 6.0mA, Continuous mode
2.0mA ~ 10.0mA, Pulsed mode - Large focus :
1.0mA ~ 20.0mA, Continuous mode
3.0mA ~ 50.0mA, Pulsed mode | • mA range - Small focus :
0.2mA ~ 6.0mA, Continuous mode
2.0mA ~ 10.0mA, Pulsed mode - Large focus:
1.0mA ~ 20.0mA, Continuous mode
3.0mA ~ 50.0mA, Pulsed mode | • mA range - Small focus :
0.2mA ~ 6.0mA, Continuous mode
1.0mA ~ 10.0mA, Pulsed mode - Large focus :
1.0mA ~ 20.0mA, Continuous mode
1.0mA ~ 48.0mA, Pulsed mode |
| | Proposed device | | Predicate device |
| | OSCAR 15 | OSCAR 15i | OSCAR 15 |
| | FXDD-1212GA (Flat Panel Detector) | E5830SD-P4A (Image Intensifier) | DualRay-Q (Flat Panel Detector) |
| Detector | • Active image area : 296.96 x 296.96 mm | • Size of incident surface : 230 mm (9") | • Active image area : 260 x 256 mm |
| | • Maximum resolution: 3.4 lp/mm | • Conversion factor
29 (cd/m2)/(uGy/s)
250 (cd/m2)/(uGy/s) | • Central Resolution: 4.6 lp/mm |
| | • Type : TFT | • Rated of contrast
30:1 (10% Area Contrast)
19:1(10mm Dia. Contrast) | • Type : CMOS |
| | • Pixel sampling resolution : 16 bits | • DQE: 65% | • Pixel sampling resolution : 14 bits |
| | • Pixel pitch : 145 μm | • Resolution
9" - 52 (Lp/cm typ.)
6" - 58 (Lp/cm typ.)
4.5" - 68 (Lp/cm typ.) | • Pixel pitch: 100 μm |
| | • MTF: 78% (0.5 lp/mm) | • Out image diameter : 25 ±0.5 mm | • MTF: 56% |
| | • DQE: 60% (0.5 lp/mm) | Previously cleared under K211780. | • DQE: 59% |
| | • Scintillator : CsI | | • Scintillator: CsI |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | Previously cleared under K180473. | | |
| Dimensions | SID : 1000 mm | SID : 1000 mm | SID : 1000 mm |
| | C-arc Panning : ±12.5° | C-arc Panning : ±12.5° | C-arc Panning : ±12.5° |
| | C-arc Orbital angle : 150° | C-arc Orbital angle : 135° | C-arc Orbital angle : 155° |
| | C-arc up/down range : 500 mm | C-arc up/down range : 500 mm | C-arc up/down range : 500 mm |
| | C-arc back/forward range : 200 mm | C-arc back/forward range : 200 mm | C-arc back/forward range : 200 mm |
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When compared to the predicate device (K172180), the proposed devices presented in this submission has the identical
- Indications for use
- Maximum output power
- X-ray source
The differences between proposed device and predicate device (K172180) are change of detector, addition of New model OSCAR 15i.
A new model, OSCAR 15i has been added to the predicate device (K172180).
The difference between OSCAR 15i and predicate device (K172180) is image acquisition parts. An Flat Panel Detector (FPD) is applied to OSCAR 15, and an Image instensifier is applied to OSCAR 15i. Brief description of technology and conversion principle of whole detector chain through an Inage intensifier is below. Total conversion is that x-ray signal irradiated to the surface of the IIT is converted into a pixel value of a digital image in proportion to its anount. That of conversion method described by several steps by the IT' and the CCD camera attached o IT output window. FPDs designed specifically for thoroscopic use and dose efficiency generally superior to the II systems that they replace, except at the lowest fluoro dose levels. Advantages include excellent image uniformity, no veiling glar or vigneting, and small, thin physical size for improved patient accessibility. Since a detective is applied to the proposed device, the performance related to image quality is also different. The image performance was evaluated according to the IEC standard through performance bench testing denonstrated that these differences do not railer and effectiveness in companson with the predicate device. Furthermore, clinical images have been evaluated by a licensed radits confirmed the sufficient diagnostic quality to provide accurate information.
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8. Safety, EMC and Performance data comparison to Predicate [21 CRF 807.92(b)]
OSCAR 15 & OSCAR 15i have been successfully completed verification and validation testing per GENORAY quality system as well engineering bench testing in support of this submission. The system has been tested and is compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-43, IEC 60601-2-54, IEC 62366. Also, OSCAR 15 & OSACR 15i comply with all applicable 21 CFR performance standards (21 CFR 1020.30, CFR 1020.31, 1020,32)
And Software was validated according to the FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical devices", FDA Guidance "Guidance for the content of premarket submissions for management of cyber security". Results demonstrated that all executed verification tests were passed.
Non-clinical validation testing has been performed to validate that OSCAR 15 & OSACR 15i conform to the intended use, claims, user needs, effectiveness of safety measures and instructions for use.
As a results, all test results were satisfactory and the result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate device.
9. Conclusion
In reference to the comparison information provided in substantial equivalence chart, and the most of functions and electronic features are similar with predicate device. We believe that the OSCAR 15 & OSCAR 15i are safe and effective as predicate device, and have no new indication for use. Therefore, OSCAR 15 & OSCAR 15i are substantially equivalent to predicate device.