(247 days)
Not Found
No
The description focuses on standard image processing and hardware components without mentioning AI/ML algorithms or training/testing data.
Yes
The device is used for "endoscopic diagnosis or treatment," indicating a therapeutic use case alongside diagnostic capabilities within the tracheobronchial tree.
Yes
The "Intended Use / Indications for Use" section states: "The Single-use Bronchoscopes have been designed to be used with the Electronic Endoscope Imaging Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree." Also, the "Device Description" states: "The electronic bronchoscope system is used for endoscopic diagnosis or treatment, and the processor collects, processes, stores, and transmits images of the human body cavity to the monitor." These statements clearly indicate the device is used for diagnostic purposes by providing visual information from the body's interior.
No
The device description clearly outlines both a physical, single-use bronchoscope (hardware) and an Electronic Endoscope Imaging Processor (hardware). While the processor includes software for image processing, the system is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a bronchoscope system used for direct visualization of the airways and tracheobronchial tree within the body. It captures images internally using an optical system and CMOS sensor.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the body. It is used for direct observation and potentially therapeutic interventions within the body.
Therefore, based on the provided information, the Single-use Bronchoscope System is an in vivo diagnostic and therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Single-use Bronchoscopes have been designed to be used with the Electronic Endoscope Imaging Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Bronchoscope System is for use in a hospital environment. The Single-use is a single-use device designed for use in adults.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
The Single-use Bronchoscope is a sterile single used flexible bronchoscope. The Electronic Endoscope Imaging Processor is a reusable monitor.
The light emitted by the LED cold light source at the distal tip of the Single-use Bronchoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output of the Electronic Endoscope Imaging Processor via the encoding circuit. The Electronic Endoscope Imaging Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the monitor. The Electronic Endoscope Imaging Processor also controls the brightness of the LEDs on the endoscope.
The optical components and their arrangement at the distal tip for all models of the Single-use Bronchoscope are identical.
The Single-use Bronchoscope is single-use medical devices that are sterilized with ethylene oxide and intended for use in adults. This product is accompanied by an electronic endoscopic image processor, which supports the use of medical monitors. The electronic bronchoscope system is used for endoscopic diagnosis or treatment, and the processor collects, processes, stores, and transmits images of the human body cavity to the monitor.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Light reflected from the body cavity, captured by CMOS image sensor.
Anatomical Site
airways and tracheobronchial tree
Indicated Patient Age Range
Adults
Intended User / Care Setting
hospital environment by trained surgical physicians who are familiar with endoscopic procedures.
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)
A series of non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Electrical safety: IEC6060-1:2005+A1:2012+A2:2020
- Electromagnetic compatibility (EMC): IEC 60601-1-2:2014 + A1:2020 / ANSI AAMI IEC 60601-1-2:2014 + A1:2021], IEC 60601-2-18:2009
- Basic Safety and Essential Performance: IEC 60601-1-6:2010 + A1:2020 + A2:2020
- Photobiological safety: IEC 62471:2006
- Biocompatibility testing: ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-11:2017, ISO 10993-23:2021
- Sterilization and Shelf Life & Packaging testing: ISO 11607-1:2019, ISO 11135:2014, ISO 10993-7: 2019
The system performance tests were performed including validation of up/down deflection, repeated flexing, water supply system, sealing performance, normal working condition, field of View, direction of view (DOV), geometric distortion, Signal-To-Noise Ratio, Image Intensity Uniformity (IIU), and color performance.
All the test results demonstrate Bronchoscope System meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate device.
No clinical test data was used to support the decision of substantial equivalence.
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.
Not Found
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
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
March 14, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Shenzhen Sanping Image Technology Co., Ltd. Vincent Pan General Manager Room 203, No.634, Shajing Road, Buchong Community, Shajing Street, Bao'an District Shenzhen, Guangdong 518104 China
Re: K242010
Trade/Device Name: Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCL012.1) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: July 10, 2024 Received: July 10, 2024
Dear Pan Vincent:
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.
1
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 (OS) 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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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-regulatory
2
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,
Joyce C. Lin -S
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
K242010
Device Name
Bronchoscope System、The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8、SP-Y-ZQGJ3.8、SP-Y-ZQGJ4.2、SP-Y-ZQGJ4.8、SP-Y-ZQGJ5.2、SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)
Indications for Use (Describe)
The Single-use Bronchoscopes have been designed to be used with the Electronic Endoscope Imaging Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Bronchoscope System is for use in a hospital environment. The Single-use is a single-use device designed for use in adults.
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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PRA Statement below
4
510(k) Summary
1. Sponsor Identification:
- Company Name: Shenzhen Sanping Image Technology Co., Ltd. >
- Address: Room 203, No.634, Shajing Road, Buchong Community, Shajing Street, > Bao'an District, Shenzhen, China
- Phone: +86-755-23223975 >
- Fax: +86-755-23223975 >
-
Contact Person (Title): Vincent Pan (General Manager)
-
E-mail: 99020278@qq.com
-
Date of Preparation: December 26, 2024
2. Name of the Device:
| Trade Name | Bronchoscope
System、The
Single-use
Bronchoscope | Model
Number/Name | Single-use Bronchoscope:
SP-Y-ZQGJ2.8、
SP-Y-ZQGJ3.8、
SP-Y-ZQGJ4.2、
SP-Y-ZQGJ4.8、
SP-Y-ZQGJ5.2、
SP-Y-ZQGJ5.8 |
|------------|----------------------------------------------------------|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| | Model
Number/Name | Electronic Endoscope Imaging
Processor: SP-TXCLQ12.1 | |
3. Common Name and Classification:
-
Device Classification Name: Bronchoscope (Flexible Or Rigid)
-
Classification Product Code: EOQ
5
-
Regulation Number: 21 CFR 874.4680
-
Class: 2
-
Review Panel: Ear Nose & Throat
- Trade/Proprietary Name: The Single-use Bronchoscopes、Bronchoscope System >
-
Common Name: Bronchoscope (flexible or rigid) and accessories
Predicate Device Information1: 4.
-
510(k) Number: K231107
- Device Classification Name: Bronchoscope (Flexible Or Rigid) >
-
Sponsor: Hunan Endoso Life Technology Co., Ltd.
- Classification Product Code: EOQ >
-
Regulation Number: 21 CFR 874.4680
-
Class: 2
-
Review Panel: Ear Nose & Throat
- Trade/Proprietary Name: Single-use Bronchoscope, Monitor for Single-Use Endoscopy, > Bronchoscope System
-
Common Name: Bronchoscope (flexible or rigid) and accessories
Predicate Device Information2: 5.
-
510(k) Number: K191828
-
Device Classification Name: Bronchoscope (Flexible Or Rigid)
- Sponsor: Hunan Vathin Medical Instrument Co., Ltd. >
-
Classification Product Code: EOQ
-
Regulation Number: 21 CFR 874.4680
-
Class: 2
-
Review Panel: Ear Nose & Throat
-
Trade/Proprietary Name: Vathin® Video Bronchoscope System
-
Common Name: Bronchoscope (flexible or rigid) and accessories
6
6. Device Description
The Single-use Bronchoscope is a sterile single used flexible bronchoscope. The Electronic Endoscope Imaging Processor is a reusable monitor.
The light emitted by the LED cold light source at the distal tip of the Single-use Bronchoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output of the Electronic Endoscope Imaging Processor via the encoding circuit. The Electronic Endoscope Imaging Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the monitor. The Electronic Endoscope Imaging Processor also controls the brightness of the LEDs on the endoscope.
The optical components and their arrangement at the distal tip for all models of the Single-use Bronchoscope are identical.
The Single-use Bronchoscope is single-use medical devices that are sterilized with ethylene oxide and intended for use in adults. This product is accompanied by an electronic endoscopic image processor, which supports the use of medical monitors. The electronic bronchoscope system is used for endoscopic diagnosis or treatment, and the processor collects, processes, stores, and transmits images of the human body cavity to the monitor.
7. Indications for Use
The Single-use Bronchoscopes have been designed to be used with the Electronic Endoscope Imaging Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Bronchoscope System is for use in a hospital environment. The Single-use Bronchoscope is a single-use device designed for use in adults.
3 page
7
8. Comparison to the predicate device
Table 1 General Comparison
| Elements of
Comparison | Proposed Device | Predicate Device 1
K231107 | Predicate Device 2
K191828 | Judgment | Review Panel | Ear Nose & Throat | Ear Nose & Throat | Ear Nose & Throat | SE |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|------------------------|--------------------------------------|--------------------------------------|--------------------------------------|----|
| Company
Name | Shenzhen Sanping Image
Technology Co., Ltd. | Hunan Endoso Life
Technology Co., Ltd. | Hunan Endoso Life
Technology Co., Ltd. | / | Class | 2 | 2 | 2 | SE |
| Model | Single-use Bronchoscope:
SP-Y-ZQGJ2.8、
SP-Y-ZQGJ3.8、
SP-Y-ZQGJ4.2、
SP-Y-ZQGJ4.8、
SP-Y-ZQGJ5.2、
SP-Y-ZQGJ5.8
Electronic Endoscope
Imaging Processor:
SP-TXCLQ12.1 | Single-use Bronchoscope:
BC12-1, BC12-2, BC20-1,
BC20-2, BC22-1, BC22-2,
BC22-3, BC28-1, BC28-2,
BC28-3
Monitor for Single-Use
Endoscopy: P1-A, P1-B,
P1-C, P1-D, P1-E, P2-A,
P2-B, P2-C, P2-D, P2-E | Vathin®H-SteriScope™
Single-use flexible Video
Bronchoscope
BCV1-01 BCV1-02
BCV1-C1
BCV1-C2 BCV1-H1
BCV1-H2
BCV1-K1 BCV1-K2
BCV1-M1
BCV1-M2 BCV1-01
BCV1-02
BCV1-S1 BCV1-S2
BCV1-U1
BCV1-U2 BCV1-W1
BCV1-W2
Vathin®VisionCenter™
Digital
Video Processor
DVP-A1 | / | Prescription
or OTC | Prescription Use | Prescription Use | Prescription Use | SE |
| Device Name | Bronchoscope System | Bronchoscope System | Vathin® Video
Bronchoscope
System | / | Anatomic
sites | airways and
tracheobronchial tree | airways and
tracheobronchial tree | airways and
tracheobronchial tree | SE |
| Classification
Product Code | EOQ | EOQ | EOQ | SE | Target
Population | Adults | Adults | Adults | SE |
| Regulation | 874.4680 | 874.4680 | 874.4680 | SE | Where used | Hospital | Hospital | Hospital | SE |
| Classification
Name | Bronchoscope (Flexible Or
Rigid) | Bronchoscope (Flexible
Or Rigid) | Bronchoscope (Flexible Or
Rigid) | SE | | | | | |
8
9
| Working
place/User | Use in a hospital
environment by trained
surgical physicians who are
familiar with endoscopic
procedures. | Use in a hospital
environment by trained
surgical physicians who are
familiar with endoscopic
procedures. | Use in a hospital
environment by trained
surgical physicians who
are familiar with
endoscopic
procedures. | SE |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|
| Technology | The Single-use
bronchoscope is inserted
through the airways and
tracheobronchial tree
during Bronchoscopy.
Anatomical images are
transmitted to the user by
the Monitor for Single-Use
Endoscopy with a CMOS
chip at the distal end of the
endoscope and the images
showing on the monitor. | The Single-use
bronchoscope is inserted
through the airways and
tracheobronchial tree
during Bronchoscopy.
Anatomical images are
transmitted to the user by
the Monitor for Single-Use
Endoscopy with a CMOS
chip at the distal end of the
endoscope and the images
showing on the monitor. | The Single-use
bronchoscope is inserted
through the airways and
tracheobronchial tree
during Bronchoscopy.
Anatomical images are
transmitted to the user by
the Monitor for Single-Use
Endoscopy with a CMOS
chip at the distal end of the
endoscope and the
images showing on the
monitor. | SE |
10
| | | | The
Vathin®H-SteriScopeTM I | |
|--------------|---------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------|----|
| | The Single-use
Bronchoscopes have been | The Single-use
Bronchoscopes have been | Single-use flexible Video
Bronchoscope have been | |
| | designed to be used with | designed to be used with
the Monitor for Single-Use | designed to be used with | |
| | the Electronic Endoscope | Endoscopy, endotherapy | the | |
| | Imaging Processor, | accessories and other | Vathin®VisionCenterTM I | |
| | endotherapy accessories | ancillary equipment for | Digital Video Processor, | |
| | and other ancillary | endoscopy within the | endotherapy accessories | SE |
| Intended Use | equipment for endoscopy
within the airways and | airways and | and other ancillary | |
| | tracheobronchial tree. | tracheobronchial tree. | equipment for endoscopy
within the airways and | |
| | The Bronchoscope System | The Bronchoscope System | tracheobronchial tree. | |
| | is for use in a hospital
environment. The | is for use in a hospital
environment. The | The Vathin® Video | |
| | Single-use Bronchoscope
is a single-use device | Single-use Bronchoscope
is a disposable device | Bronchoscope System is | |
| | designed for use in adults. | designed for use in adults. | for use in a hospital
environment. | |
Table 2 Safety factor & Performance Comparison
| Safety factor &
| Performance | Proposed Device | Predicate Device1 | Predicate Device2 | Judgment |
|---|---|---|---|---|
| Electrical Safety | Compliance with IEC | |||
| 60601-1 | Compliance with | |||
| IEC 60601-1 | Compliance with IEC | |||
| 60601-1 | SE | |||
| EMC | Compliance with IEC | |||
| 60601-1-2 | Compliance with | |||
| IEC 60601-1-2 | Compliance with IEC | |||
| 60601-1-2 | SE | |||
| Usability | ||||
| Engineering | Compliance with IEC | |||
| 62366-1 | Compliance with | |||
| IEC 62366-1 | Compliance with IEC | |||
| 62366-1 | SE | |||
| Biocompatiblity | Compliance with ISO | |||
| 10993-1 | Compliance with | |||
| ISO 10993-1 | Compliance with ISO | |||
| 10993-1 | SE | |||
| Safety factor & | ||||
| Performance | Proposed Device | Predicate Device1 | Predicate Device2 | Judgment |
| Connect to | ||||
| devices | Monitor | Monitor | Monitor | SE |
| Type of Imager | CMOS | CMOS | CMOS | SE |
| Light Source | Internal LED | Internal LED | Internal LED | SE |
| Direction of | ||||
| View (°) | forward | forward | forward | SE |
| Working Length | ||||
| (mm) | 650 | 600mm | 600/700mm | Note 1 |
| Depth of Field (mm) | 3 - 50 | 3 - 50 | 3mm~30mm | SE |
| Type of Scope | Flexible | Flexible | Flexible | SE |
| Distal end | ||||
| outer diameter |