UL UHD-Clear View 4K Camera System (UL-3Chip 4K)

K250462 · Univlabs Technologies Private Limited · FET · Aug 11, 2025 · Gastroenterology, Urology

Device Facts

Record IDK250462
Device NameUL UHD-Clear View 4K Camera System (UL-3Chip 4K)
ApplicantUnivlabs Technologies Private Limited
Product CodeFET · Gastroenterology, Urology
Decision DateAug 11, 2025
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 876.1500
Device ClassClass 2

Intended Use

The UL UHD-Clear View 4K Camera System (UL-3Chip 4K), consisting of a Camera Control Unit and an Endoscopic Camera Head, is indicated for use with compatible endoscopes to provide visualization during general endoscopic procedures. These procedures may involve the visual inspection of internal anatomical structures to support diagnostic or therapeutic interventions. Patient suitability for particular endoscopic procedures must be determined by the responsible physician based on the individual's clinical condition.

Device Story

System comprises Camera Control Unit (CCU) and Endoscopic Camera Head; captures visual data via compatible endoscopes; processes electronic signals from camera head; outputs 4K resolution video to external medical-grade display monitors. Used in clinical settings for general endoscopic procedures; operated by physicians. Provides real-time visualization of internal anatomy to support diagnostic or therapeutic interventions. Benefits include high-resolution imaging for improved anatomical inspection.

Clinical Evidence

Bench testing only. Comparative testing against predicate evaluated spatial resolution, depth of field, field of view, zoom characterization, and color enhancement. Device tested for safety/performance per IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-18.

Technological Characteristics

CMOS sensor technology; 3840x2160p resolution; 12G/3G-SDI and HDMI display ports; adaptive zoom. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-18 (endoscopic equipment).

Indications for Use

Indicated for patients undergoing general endoscopic procedures requiring visualization of internal anatomical structures for diagnostic or therapeutic interventions. No specific age or gender restrictions; patient suitability determined by physician.

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

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION August 11, 2025 Univlabs Technologies Private Limited Vishwanath Pratap Singh Engineering Director Plot No : 31, Sector -33, Near Info-City 2 Haryana Gurugram, HR 122003 India Re: K250462 Trade/Device Name: UL UHD-Clear View 4K Camera System (UL-3Chip 4K) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FET Dated: June 27, 2025 Received: July 7, 2025 Dear Vishwanath Pratap Singh: 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 {1} K250462 - Vishwanath Pratap Singh Page 2 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 systems (QS) regulation (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- {2} K250462 - Vishwanath Pratap Singh Page 3 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, TANISHA L. HITHE - S Digitally signed by TANISHA L. HITHE - S Date: 2025.08.11 20:45:14 -04'00' Tanisha Hithe, M.S., M.HS. 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 {3} K250462 Page 1 of 1 | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K250462 | ? | | Please provide the device trade name(s). | | ? | | UL UHD-Clear View 4K Camera System (UL-3Chip 4K) | | | | Please provide your Indications for Use below. | | ? | | The UL UHD-Clear View 4K Camera System (UL-3Chip 4K), consisting of a Camera Control Unit and an Endoscopic Camera Head, is indicated for use with compatible endoscopes to provide visualization during general endoscopic procedures. These procedures may involve the visual inspection of internal anatomical structures to support diagnostic or therapeutic interventions. Patient suitability for particular endoscopic procedures must be determined by the responsible physician based on the individual's clinical condition. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | UL UHD-Clear View 4K Camera System {4} K250462 Page 1 of 2 | 510(k) #: K250462 | 510(k) Summary | Prepared on: 2025-07-04 | | --- | --- | --- | | Contact Details | | 21 CFR 807.92(a)(1) | | Applicant Name | UnivLabs Technologies Private Limited | | | Applicant Address | Plot No : 31, Sector -33, Near Info-City II Haryana Gurugram HR 122003 India | | | Applicant Contact Telephone | +91-9560925518 | | | Applicant Contact | Mr. SUNIL KUMAR SINGH | | | Applicant Contact Email | sunil@univlabs.in | | | Correspondent Name | UnivLabs Technologies Private Limited | | | Correspondent Address | Plot No : 31, Sector - 33, Near Info-City II Haryana Gurugram HR 122003 India | | | Correspondent Contact Telephone | +91-9491729764 | | | Correspondent Contact | Mr. Venkataramana Anant Bhagavati | | | Correspondent Contact Email | regulatory@univlabs.in | | | Device Name | | 21 CFR 807.92(a)(2) | | Device Trade Name | UL UHD-Clear View 4K Camera System (UL-3Chip 4K) | | | Common Name | Endoscope and accessories | | | Classification Name | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | | | Regulation Number | 876.1500 | | | Product Code(s) | FET | | | Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) | | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | K201135 | Image1 S CCU (TC200US, TC201US, TC300US, TC301US, TC302US, TC304US); Image1 S 4U Camera Head (TH120) | FET | | Device Description Summary | | 21 CFR 807.92(a)(4) | | The UL UHD-Clear View 4K Camera System (UL-3Chip-4K) consisting of a Camera Control Unit (CCU) and Endoscopic Camera Head supports video output up to 4K resolution for connection to external medical-grade display monitors. The Camera Control Unit (CCU) processes electronic signals transmitted from an endoscopic camera head and outputs the video signal to an external display monitor. | | | | Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) | {5} K250462 Page 2 of 2 The UL UHD-Clear View 4K Camera System (UL-3Chip 4K), consisting of a Camera Control Unit and an Endoscopic Camera Head, is indicated for use with compatible endoscopes to provide visualization during general endoscopic procedures. These procedures may involve the visual inspection of internal anatomical structures to support diagnostic or therapeutic interventions. Patient suitability for particular endoscopic procedures must be determined by the responsible physician based on the individual's clinical condition. ## Indications for Use Comparison **21 CFR 807.92(a)(5)** The subject device, UL UHD-Clear View 4K Camera System, is indicated for use with compatible endoscopes to provide visualization during general endoscopic procedures. The predicate device, Karl Storz Image 1S CCU and 4U Camera Head, is indicated for visualization, image recording, and documentation during endoscopic and microscopic procedures. The subject device does not support image recording or documentation. These are minor differences, and the subject device's indications represent a subset of the predicate's. Additional labeling language in the subject device (e.g., references to physician judgment and support for diagnostic or therapeutic interventions) is intended to provide clarity and is consistent with the IMDRF definition of "Indications for Use." It does not broaden the scope of intended use. Therefore, the indications for use of the subject device do not constitute a new indication for use. ## Technological Comparison **21 CFR 807.92(a)(6)** The UL UHD-Clear View 4K Camera System (UL-3Chip-4K) consisting of a Camera Control Unit (CCU) and Endoscopic Camera Head supports video output up to 4K resolution for connection to external medical-grade display monitors. The Camera Control Unit (CCU) processes electronic signals transmitted from an endoscopic camera head and outputs the video signal to an external display monitor. Both the subject and predicate device are based on CMOS Sensor technology with a sensor resolution of 3840*2160p. Both Subject and predicate device(s) have adaptive zoom and 12G/3G-SDI display port(s). Additionally, the subject device has additional two HDMI port(s). ## Non-Clinical and/or Clinical Tests Summary & Conclusions **21 CFR 807.92(b)** Comparative Bench Testing was performed between the subject device and predicate device for the following parameters in order to ensure Proper Characterization of Image Quality : - Spatial Resolution - Depth of Field - Field of View - Zoom Characterization - Color Enhancement There are no performance standards or special controls developed for Camera Control Unit (CCU) and Endoscopic Camera Head(s). However, UL UHD-Clear View 4K Camera System (UL-3Chip 4K) is tested according to following FDA recognized consensus standards : - IEC 60601-1 : 2005 + AMD1 : 2012 + AMD2 : 2020 : Medical Electrical Equipment - Part 1 : General Requirements for Basic Safety and Essential Performance. - IEC 60601-1-2 : 2014 + AMD1 : 2020 : Medical Electrical Equipment - Part 1-2 : Collateral Standard : Electromagnetic Disturbances - Requirements and Tests. The essential performance for the above tests confirms to IEC 60601-2-18 : 2009 : Particular requirements for the basic safety and essential performance of endoscopic equipment. Software Verification & Validation Testing was performed as per Content of Premarket Submissions for Device Software Functions (Moderate Level of Concern). "Not Applicable" The subject and predicate device have similar indications for use and technological characteristics as the predicate device. The minor differences between the subject and predicate devices do not raise different questions of safety and effectiveness. Non-clinical performance testing (Bench Testing), electromagnetic compatibility (EMC), electrical, mechanical, and thermal safety, demonstrates that the subject device is as safe and effective as the predicate. Therefore, the UL UHD-Clear View 4K Camera System (UL-3Chip 4K) is substantially equivalent to the predicate device.
Innolitics
510(k) Summary
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