4K NIR/ICG Imaging System
Device Facts
| Record ID | K260318 |
|---|---|
| Device Name | 4K NIR/ICG Imaging System |
| Applicant | Zhejiang Healnoc Technology Co., Ltd. |
| Product Code | GCJ · Gastroenterology, Urology |
| Decision Date | May 26, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
Indications for Use
Endoscopic Camera System: Upon intravenous administration and use of an ICG consistent with its approved label, the Endoscopic Camera System is intended to provide real-time endoscopic visible and near-infrared fluorescence visualization. The System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts, using near-infrared imaging. Upon interstitial administration and use of an ICG consistent with its approved label, the Endoscopic Camera System is intended to be used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Endoscopic Cold Light Source: The Endoscopic Cold Light Source in combination with the camera head and camera control unit is used for visualizing endoscopic procedures.
Device Story
4K NIR/ICG Imaging System comprises an endoscopic camera system (camera control unit, camera head) and an endoscopic cold light source (LED/LD semiconductor laser). Device captures visible and near-infrared (NIR) fluorescence signals during minimally invasive surgery. Light source provides white light for standard visualization and 785nm NIR laser for ICG excitation. System processes inputs to produce 4K resolution video output for surgical monitors. Used in hospital settings by physicians to assess blood flow, tissue perfusion, biliary ducts, and lymphatic structures. Output assists surgeons in real-time intraoperative decision-making and visualization. Benefits include enhanced anatomical assessment and perfusion monitoring during surgery.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench performance testing, including noise, dynamic range, penetration depth, sensitivity, signal linearity, uniformity, crosstalk, color reproduction, OECFs, depth of field, distortion, resolution, and system delay tests.
Technological Characteristics
System includes camera control unit, camera head, and cold light source (white LED and 785nm NIR laser). Supports 4K resolution (4096x2160P). Connectivity via SDI and HDMI. Sterilization: Autoclave. Electrical safety: Class I, CF-type. Laser class: 3R. Complies with IEC 60601-1, IEC 60601-2-18, IEC 60825-1, and IEC 62471.
Indications for Use
Indicated for patients undergoing minimally invasive surgery requiring real-time endoscopic visible and near-infrared fluorescence visualization. Used for visual assessment of vessels, blood flow, tissue perfusion, major extra-hepatic bile ducts, and intraoperative visualization of the lymphatic system (vessels and nodes) following ICG administration.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
Predicate Devices
- PINPOINT Endoscopic Fluorescence Imaging System (K182606)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 26, 2026
Zhejiang Healnoc Technology Co., Ltd.
% Kyra Kang
Director
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm.1308, Baohua International Plaza, W. Guangzhong Rd. 555
Jingan District
Shanghai,
China
Re: K260318
Trade/Device Name: 4K NIR/ICG Imaging System
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: Class II
Product Code: GCJ, IZI
Dated: January 21, 2026
Received: January 30, 2026
Dear Kyra Kang:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K260318 - Kyra Kang
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assistance/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,
JESSICA CARR -S
Jessica Carr, PhD
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K260318 | |
| Device Name 4K NIR/ICG Imaging System | |
| Indications for Use (Describe) Endoscopic Camera System: Upon intravenous administration and use of an ICG consistent with its approved label, the Endoscopic Camera System is intended to provide real-time endoscopic visible and near-infrared fluorescence visualization. The System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts, using near-infrared imaging. Upon interstitial administration and use of an ICG consistent with its approved label, the Endoscopic Camera System is intended to be used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Endoscopic Cold Light Source: The Endoscopic Cold Light Source in combination with the camera head and camera control unit is used for visualizing endoscopic procedures. | |
| 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: 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." | |
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510(k) Summary – K260318
I. Submitter
Zhejiang Healnoc Technology Co., Ltd.
Room 1201, 12th Floor, Building 3, No. 580, Liye Road, Changhe Subdistrict, Binjiang
District, Hangzhou, China (Zhejiang) Pilot Free Trade Zone, Zhejiang, 310056, China
Contact person: Ms. QiongHua Wei
Tel.: 0571-85172996
E-mail: wei_qionghua@healnoc.com
Preparation date: May 26th, 2026
Submission Correspondent
Ms. Kyra Kang
Landlink Healthcare Technology (Shanghai) Co., Ltd.
E-mail: kyra.kang@landlink-health.com
II. Proposed Device
Device Trade Name: 4K NIR/ICG Imaging System
Common name: Endoscope and accessories
Regulation Number: 21 CFR 876.1500
Regulatory Class: Class II
Primary product code: GCJ
Secondary product code: IZI
Review Panel: Radiology
III. Predicate Devices
510(k) Number: K182606
Trade name: PINPOINT Endoscopic Fluorescence Imaging System
Common name: Endoscope and accessories
Classification: Class II
Product Code: GCJ, IZI
Manufacturer: Novadaq Technologies ULC (now a part of Stryker)
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## IV. Device description
The 4K NIR/ICG Imaging System consists of the Endoscopic Camera System and the Endoscopic Cold Light Source.
Endoscopic Camera System is composed of a camera control unit and a camera head. The Endoscopic Camera System is for use with endoscopic cold light source and endoscope and is used for visualizing and documenting endoscopic procedures.
The Endoscopic Cold Light Source consists of a light source and a power cord. The light source features LED lamp assembly output white light and LD semiconductor laser output near-infrared laser, and contains the fiber optic light cable. The light source consists of a panel, a touchscreen, a control circuit, a brightness adjustment circuit, a housing, a fan assembly, an LED lamp assembly, an LD lamp assembly, a heat sink and a switching power supply. The Endoscopic Cold Light Source in combination with the camera head and camera control unit is used for visualizing endoscopic procedures.
## V. Indications for use
**Endoscopic Camera System:**
Upon intravenous administration and use of an ICG consistent with its approved label, the Endoscopic Camera System is intended to provide real-time endoscopic visible and near-infrared fluorescence visualization. The System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts, using near-infrared imaging.
Upon interstitial administration and use of an ICG consistent with its approved label, the Endoscopic Camera System is intended to be used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
**Endoscopic Cold Light Source:**
The Endoscopic Cold Light Source in combination with the camera head and camera control unit is used for visualizing endoscopic procedures.
## VI. Comparison of technological characteristics with the predicate devices
The comparison and discussion between the subject device and the predicate devices are listed in the table below.
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General Comparison
| Characteristics | Proposed device | Predicate device (K182606) | Discussio n |
| --- | --- | --- | --- |
| Device Name | 4K NIR/ICG Imaging System | PINPOINT Endoscopic Fluorescence Imaging System | / |
| Product Code | GCJ, IZI | GCJ, IZI | Same |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Classification | Class II | Class II | Same |
| Type of use | Prescription Use | Prescription Use | Same |
| Intended use & Indications for Use | Endoscopic Camera System: Upon intravenous administration and use of an ICG consistent with its approved label, the Endoscopic Camera System is intended to provide real-time endoscopic visible and near-infrared fluorescence visualization. The System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts, using near-infrared imaging. Upon interstitial administration and use of an | Upon intravenous administration of TRADENAME (ICG drug product), the PINPOINT Endoscopic Fluorescence Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography. The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The PINPOINT System enables surgeons to | Same |
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| | ICG consistent with its approved label, the Endoscopic Camera System is intended to be used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Endoscopic Cold Light Source: The Endoscopic Cold Light Source in combination with the camera head and camera control unit is used for visualizing endoscopic procedures. | perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Upon interstitial administration of TRADENAME (ICG drug product), the PINPOINT System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. | |
| --- | --- | --- | --- |
| Applicable | Physicians | Physicians | Same |
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| user | | | |
| --- | --- | --- | --- |
| Environment of use | Healthcare facility /hospital | Healthcare facility /hospital | Same |
| Single use / Reusable | Reusable | Reusable | Same |
| Sterile /non sterile | Marketed as non-sterile | Marketed as non-sterile | Same |
| Device System components | Endoscopic Camera System is composed of a camera control unit and a camera head.Endoscopic Cold Light Source consists of a cold light source and a power cord. | -Endoscopic video processor/illuminator(VPI)-Laparoscope-Camera head-Light guide cable | Analysis 1 |
| Video output signals | SDI (3G-SDI,12G-SDI)DVIHDMI(HDMI 1.4,HDMI 2.0) | HD-SDI, 3G-SDI, DVI | Analysis 2 |
| Video output resolution | 4096×2160P, 3840×2160P, 1920×1080P | 1920×1080 | Analysis 3 |
| Voltage | 100V-240V~ | 100-240V~ | Same |
| Frequency | 50/60 Hz | 50/60 Hz | Same |
| Power consumption | 100VA | 300VA | Analysis 4 |
| Image sensors | 2 CMOS sensors | CMOS HD sensor assembly | Analysis 5 |
| Aspect ratio | 16:9 | 16:9 | Same |
| Light sources | White LED and near-infrared laser | -Visible (VIS): Light-emitting diode Array-Near infrared (NIR): NIR laser diode | Same |
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| Wavelength( NIR) | 785±5nm | 805±4nm | Analysis 6 |
| --- | --- | --- | --- |
| Power density(NIR) | 27.43 mW/cm2 | 29.51 mW/cm2 | Analysis 7 |
| Working distance | 50mm | 50mm | Same |
| Light guide cable | Transmission spectrum: Visible + NIR | Transmission spectrum: Visible + NIR | Same |
| | Sterilization: Autoclave | Sterilization: Autoclave | Same |
| Imaging agent | Indocyanine Green (ICG) | Indocyanine Green (ICG) | Same |
| Type of protection against electric shock (as per IEC 60601-1) | Class I | Class I | Same |
| Degree of protection against electric shocks (as per IEC 60601-1) | CF-type | CF-type | Same |
| Laser classification (as per IEC 60825-1) | Class 3R | Class 3R | Same |
| Radio | Group 1, Class A | Group 1, Class A | Same |
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| frequency emissions (as per CISPR 11) | | | |
| --- | --- | --- | --- |
## Analysis 1 Device system components
The Proposed Device does not include a laparoscope as a provided component. However, it is designed and intended to be used with laparoscopes that are legally marketed in the United States. The compatibility with commercially available laparoscopes ensures that the system functions identically to the Predicate Device in terms of imaging capability, light delivery, and clinical application. No additional safety or effectiveness risks are introduced, as the laparoscope is a standalone, cleared device used in accordance with its labeled instructions.
## Analysis 2 Video Output Signals
The Proposed Device provides additional video output formats (12G-SDI and HDMI 1.4/2.0) compared to the Predicate Device. These formats are backward compatible with existing HD-SDI/3G-SDI and DVI interfaces commonly used in surgical environments. The inclusion of HDMI 1.4/2.0 and 12G-SDI supports higher resolution (4K) and broader monitor compatibility, which are enhancements that do not alter the fundamental video output function or introduce new risks. All output signals comply with recognized industry standards and maintain electrical and signal compatibility with standard medical displays.
## Analysis 3 Video output resolution
These higher resolutions provide enhanced image clarity and detail, which are beneficial for surgical visualization but do not alter the fundamental imaging function or introduce new risks. The device maintains backward compatibility with 1080P output, ensuring it can be used with existing monitor systems. The increased resolution is achieved through advancements in imaging sensor and processing technology, which are well-established and do not affect safety or performance.
## Analysis 4 Power Consumption
Lower power consumption reduces thermal output, enhances device reliability, and decreases operational costs, without compromising performance or safety. The electrical safety and compliance with relevant standards are maintained, and the device continues to operate within typical hospital power supply specifications.
## Analysis 5 Image sensors
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This dual-sensor configuration is a technological advancement that enhances imaging capability without altering the fundamental imaging mechanism or introducing new risks. Both systems comply with relevant imaging performance and safety standards.
## Analysis 6 Wavelength(NIR)
The principle of ICG fluorescence imaging is that indocyanine green (ICG) absorbs NIR light in the wavelength range of 750 - 810 nm and subsequently emits fluorescence. Both the wavelength(NIR) of subject device and predicate device are in the range of 750 - 810 nm, and the subject device has been tested according to IEC 60825-1, so the difference will not affect the safety and effectiveness.
## Analysis 7 Power density(NIR)
The power density(NIR) of subject device is lower than that of predicate device, the lower power density(NIR), the lower risk of thermal injury, and the power density(NIR) of subject device has been verified, and the subject device has been tested according to IEC 60825-1, so the difference will not affect the safety and effectiveness.
## VII. Non-Clinical Testing
The device described in this summary, were tested and demonstrated to be in conformance with the following standards:
### Performance testing :
A comparison testing with the predicate device was conducted to demonstrate substantial equivalence. Specifically, tests were performed on the following items:
- Noise and Dynamic Range Test of Near-infrared Fluorescence Imaging;
- Penetration depth Test of Near-infrared Fluorescence Imaging;
- Sensitivity and Signal linearity Test of Near-infrared Fluorescence Imaging;
- Signal Uniformity Test Report of Near-infrared Fluorescence Imaging;
- Excitation Light Crosstalk of Near-infrared Fluorescence Imaging Test;
- Noise and Dynamic Range Test;
- Color Reproduction Test;
- Intensity Uniformity Test;
- Opto-electronic conversion function(OECFs) Test;
- Depth of Field Test;
- Relative Distortion Test;
- Resolution Test
- Image Frame Frequency and System Delay Test
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Software
Guidance for Industry and Food and Drug Administration Staff-Content of Premarket Submissions for Device Software Functions
Cybersecurity
Guidance for Industry and Food and Drug Administration Staff-Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
Electrical Safety and EMC
IEC 60601-1-2
IEC TS 60601-4-2
IEC 60601-1
IEC 60601-2-18
IEC 60825-1
IEC 62471
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate device.
