(211 days)
Not Found
No
The document describes an optical colposcope system for magnified viewing and imaging. There is no mention of AI, ML, image processing beyond basic visualization, or any data sets for training or testing algorithms. The performance studies focus on optical and illumination characteristics.
No
The device is a diagnostic tool used for magnified viewing and imaging to assist in diagnosing abnormalities, not for providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the magnified viewing of the tissues... in order to assist doctors in diagnosing abnormalities such as lesions or cancer".
No
The device description explicitly states it is an "optical colposcope" and mentions features like "direct visual, photographic, and/or high resolution color imaging," indicating it is a hardware device with optical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that the Cooper Surgical Leisegang Colposcope Systems are used for magnified viewing of tissues in situ (within the body). It's a visualization tool, not a test performed on a sample outside the body.
- Intended Use: The intended use is to "assist doctors in diagnosing abnormalities... and selecting areas for biopsy." This involves direct observation, not laboratory analysis of a sample.
- Device Description: The description emphasizes "optical colposcopes designed for non-contact visualization."
Therefore, the device falls under the category of a medical device used for direct examination and visualization, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Cooper Surgical Leisegang Colposcope Systems are intended for the magnified viewing of the tissues of the vagina, cervix, and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from Cooper Surgical Leisegang Colposcope Systems may be viewed directly and/or on a color monitor (if so equipped). The Cooper Surgical Leisegang Colposcope Systems are intended for use in hospitals, clinics, and doctor's offices.
Product codes
HEX
Device Description
The Cooper Surgical Leisegang Colposcope(s) and accessories are optical colposcopes designed for non-contact visualization of the tissues of the cervix, vulva, vagina, and anogenital areas. Depending on the model and/or mode selected, they provide direct visual, photographic, and/or high resolution color imaging of the selected area.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, cervix, and external genitalia (anogenital areas)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
doctors / hospitals, clinics, and doctor's offices
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 testing and attribute comparisons have been used to establish that the features and performance of the subject devices are substantially equivalent to the predicates. The following attributes are listed below along with the specific Order Code
- Resolution (referenced USAG Chart NBS 1963A)
- Depth of Field, measured at the fixed Working Distance of 300mm
- Distortion less than or equal to +7% at all magnifications
- LED illumination testing - no significant spectrum below 400 nm, emission spectrum measured Ra=92, with no undesirable temperature rise in the subject field; the measured UV irradiance = 5.81569uW/m2. Enclosure surfaces did not exceed 74°C.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1630 Colposcope.
(a)
Identification. A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.(b)
Classification. Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2014
Cooper Surgical, Inc. % Tim Lohnes Senior Regulatory Consultant Orchid Design 80 Shelton Technology Center Shelton, CT 06484
Re: K140754
Trade/Device Name: Cooper Surgical Leisegang Colposcope System Regulation Number: 21 CFR§ 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: HEX Dated: September 19, 2014 Received: September 23, 2014
Dear Tim Lohnes,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K140754
Device Name Leisegang Colposcope Systems
Indications for Use (Describe)
The Cooper Surgical Leisegang Colposcope Systems are intended for the magnified viewing of the tissues of the vagina, cervix, and external genitalia in order to assist doctors ing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from Cooper Surgical Leisegang Colposcopes may be viewed directly and/or on a color monitor (if so equipped). Cooper Surgical Leisegang Colposcopes are intended for use in hospitals, clinics, and doctor's offices.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
er Surgical
Cooper Surgical
75 Corporate Drive Trumbull, Connecticut (203) 601-5200 FAX (203) 601-9870
510(K) SUMMARY:
| SUBMITTER: | Cooper Surgical, Inc.
75 Corporate Drive,
Trumbull, CT 06611 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Tim M. Lohnes, Senior Regulatory Consultant,
Orchid Design,
80 Shelton Technology Center
Shelton, CT 06484
203-922-0105 |
| DATE PREPARED: | October 22, 2014 |
| TRADE/PROPRIETARY NAME: | Cooper Surgical Leisegang Colposcope Systems System(s) |
| COMMON/USUAL NAME: | Colposcope (colpomicroscope) and Accessories |
| CLASSIFICATION NAME: | Class II: Obstetrical and Gynecological Diagnostic Devices
CFR Section: 21 CFR 884.1630 |
| PREDICATE DEVICE(S): | Leisegang Colposcope(s),
K940094,
Galileo Corp. Leisegang Video Colposcope,
K981958,
MedGyn Products, Inc. Digital Video Colposcope,
K122973. |
DEVICE DESCRIPTION:
The Cooper Surgical Leisegang Colposcope(s) and accessories are optical colposcopes designed for non-contact visualization of the tissues of the cervix, vulva, vagina, and anogenital areas. Depending on the model and/or mode selected, they provide direct visual, photographic, and/or high resolution color imaging of the selected area.
INTENDED USE:
Non-contact visualization of the tissues of the cervix, vulva, vagina, and anogenital areas.
4
INDICATIONS FOR USE:
The Cooper Surgical Leisegang Colposcope Systems are intended for the magnified viewing of the tissues of the vagina, cervix, and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from Cooper Surgical Leisegang Colposcope Systems may be viewed directly and/or on a color monitor (if so equipped). The Cooper Surgical Leisegang Colposcope Systems are intended for use in hospitals, clinics, and doctor's offices.
TECHNOLOGICAL CHARACTERISTICS:
The Cooper Surgical Leisegang Colposcope(s) are 300mm working distance binocular colopscope(s), consisting of an objective lens, binocular tubes, adjustable oculars (evepieces) to provide compensation for myopia and hyperopia, a magnification changer and green filters (as applicable), and LED illumination, incorporated in a common housing.
All Cooper Surgical Leisegang Colposcope(s) models are based on 3 versions of the scope body;
-
non-photographic, which provide visual imaging (via the oculars) only,
-
external photographic, to which a standard digital camera can be mounted to the scope body via a standard bayonet mount; the camera image corresponds to the image provided via the oculars.
-
integral photographic, with a 1/4" IR CCD color camera integral to the scope body, the camera image corresponds to the image provided via the oculars. There are two integral cameras available, one providing analog S-Video (NTSC) output, and a digital unit which provides video output via a UBS cable.
SCOPE OPTIONS:
The basic Cooper Surgical Leisegang Colposcope(s) described above can be provided with various options, including:
-
Fixed magnification of 15x (non-photographic models only), and variable magnification ranges of 3.75, 7.5, 15x, or 7.5, 15.0, 30.0x.
-
0° (straight) or 45° oculars.
-
Green filters (not available with the 45° oculars).
ACCESSORY OPTIONS:
There are various accessories available for the Cooper Surgical Leisegang Colposcope(s), including stands, cameras, monitors (where applicable). The Cooper Surgical Order Code denotes the Scope options, and the accessories included in that particular Order Code. The Order Codes are listed in this Summary.
MATERIALS:
The Cooper Surgical Leisegang Colposcope(s) and accessories are not indicated or intended for patient contact; therefore the materials used in their construction have not been specifically evaluated for biocompatibility.
5
COMMON FEATURES and SPECIFICATIONS;
The following features and specification are common to all models of Cooper Surgical Leisegang Colposcope(s) , regardless of any other features or options;
-
Illumination - Light Emitting Diode (LED)
-
Working Distance – 300mm for all models.
-
Diopter adjustment - ±7 for all models.
-
Interpupillary distance - individually, continuously adjustable on all models.
-
View Direction - with 0° oculars, straight, with 45° oculars, inclined.
-
Depth of Field - at the fixed Working Distance of 300mm ± 10mm, the Depth of Field at the specified 300mm working distance is 290mm to 310mm for all models.
- Distortion - less than +7% at the specified 300mm Working Distance.
PERFORMANCE DATA:
Non-clinical testing and attribute comparisons have been used to establish that the features and performance of the subject devices are substantially equivalent to the predicates. The following attributes are listed below along with the specific Order Code
-
Resolution (referenced USAG Chart NBS 1963A)
-
Depth of Field, measured at the fixed Working Distance of 300mm
-
Distortion ≤ +7% at all magnifications
-
LED illumination testing - no significant spectrum below 400 nm, emission spectrum measured Ra=92, with no undesirable temperature rise in the subject field; the measured UV irradiance = 5.81569uW/m2. Enclosure surfaces did not exceed 74°C.
NON-CLINICAL TESTING:
The following Performance Standards were met;
IEC 60601-1:2005 + COOR. 1 (2006) + COOR. 2 (2007), "Medical Electrical Equipment, Part 1: General Requirements for basic safety and essential performance",
IEC 60601-1-2: 2007 (310 Edition), "Medical Electrical Equipment for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility'.
6
IEC 60601-2-41, "Medical Electrical Equipment Part 2-41: Particular requirements for the basic safety and performance of surgical luminaries and luminaries for diagnosis".
COMPARISION TO PREDICATE DEVICE(S):
The subject Cooper Surgical Leisegang Colposcope(s) and the Predicate devices have the same intended use, which is non-contact visualization of the tissues of the cervix, vulva, vagina, and anogenital areas.
Various design and manufacturing changes made to the Cooper Surgical Leisegang Colposcope(s) subsequent to the predicate clearances K940094 and K981958 were evaluated in detail and analysis provided which demonstrate that the Cooper Surgical Leisegang Colposcope(s) were substantially equivalent to the predicate(s).
The Cooper Surgical Leisegang Colposcopes with fixed 15x magnification yielded performance equivalent to the variable magnification devices when set to 15x.
The Cooper Surgical Leisegang Colposcope(s) demonstrate only slight differences in design, construction and specifications when compared to the predicates as well as the MedGyn device. The Cooper Surgical Leisegang Colposcope can be provided with integral video cameras and LED light sources, green filters, and various magnification levels.
CONCLUSION:
The Indications For Use for the Cooper Surgical Leisegang Colposcope(s) System is the same as the predicate devices, and the differences in features between the devices do not raise any new questions of safety or effectiveness. The evaluations conducted confirm the validity of the comparisons of the various attribute comparisons, establishing that the Cooper Surgical Leisegang Colposcope(s)System is substantially equivalent to the predicate device(s) .
ORDER CODES:
The Cooper Surgical Leisegang Colposcope(s) System Order Codes are listed below, including the various options and accessories associated with the specific Code.
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-----------|-------------------|--------|-------------------|--------|------------------|------------|------------|
| Optik1-00 | 3.75, 7.5,
15x | 0° | None | n/a | 76, 38,
19mm | 18, 18, 18 | Tilt Stand |
Non-Photographic Models
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-----------|-------------------|--------|-------------------|--------|------------------|------------|------------------|
| Optik1-01 | 3.75, 7.5,
15x | 0° | None | n/a | 76, 38,
19mm | 18, 18, 18 | Rolling
Stand |
7
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-----------|-------------------|--------|-------------------|--------|------------------|------------|--------------------|
| Optik1-02 | 3.75, 7.5,
15x | 0° | None | n/a | 76, 38,
19mm | 18, 18, 18 | Swing
Arm Stand |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-----------|-------------------|--------|-------------------|--------|------------------|------------|------------------------------|
| Optik1-03 | 3.75, 7.5,
15x | 0° | None | n/a | 76, 38,
19mm | 18, 18, 18 | Balance-
O-Matic
Stand |
| US
Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------|-----------------|--------|-------------------|--------|-------------------|------------|------|
| n/a | 7.5, 15,
30x | 0° | None | n/a | 46, 23,
11.5mm | 18, 18, 18 | na |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|----------|-----------------|-----------------------------|-------------------|--------|-------------------|------------|------|
| TBD | 7.5, 15,
30x | 45° (no
green
filter) | None | n/a | 46, 23,
11.5mm | 18, 18, 18 | na |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|----------|-----------|-----------|-------------------|--------|------------------|------------|------|
| n/a | 15x Fixed | ಲ್ಲಿ ಮಾರ್ | None | n/a | 23mm | 18 | n/a |
| US
Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------|-----------|--------|-------------------|--------|------------------|------------|-----------|
| n/a | 15x Fixed | 0° | None | n/a | 23mm | 18 | Tilt only |
Scope Head 3ML, External Photographic Models
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|--------|------------------|-----------------------------------|--------------------------------|
| Optik2-
05-002 | 3.75, 7.5,
15x | 0° | For 1.0"
CCD | DSLR | 76, 38,
19mm | 18,
Camera
5.6, 12.5,
18 | Balance-
O-Matic
Stand |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
| Optik2-
04-002 | 3.75, 7.5,
15x | 0° | For 1.0"
CCD | DSLR | 76, 38,
19mm | 18,
Camera
5.6, 12.5,
18 | Swing
Arm Stand
& Camera |
8
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|--------|------------------|----------------------------------|-----------------|
| Optik2-
03-002 | 3.75, 7.5,
15x | 0° | For 1.0"
CCD | DSLR | 76, 38,
19mm | 18,
Camera
5.6, 12.5
18 | Upright
base |
Scope Head 3ML, External Photographic Models
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-----------|-------------------|--------|-------------------|--------|------------------|------------------------------------|-----------------------------------|
| Optik2-04 | 3.75, 7.5,
15x | 0° | For 1.0"
CCD | DSLR | 76, 38,
19mm | 18,
Camera,
5.6, 12.5,
18 | Swing Arm
Stand (no
camera) |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-----------|-------------------|--------|-------------------|--------|------------------|----------------------------------|---------------------------------------|
| Optik2-05 | 3.75, 7.5,
15x | 0° | For 1.0"
CCD | DSLR | 76, 38,
19mm | 18,
Camera
5.6, 12.5
18 | Balance-
O-Matic
(no
camera) |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|--------|------------------|-----------------------------------|--------------------|
| Optik2-
04-004 | 3.75, 7.5,
15x | 0° | For 1.0"
CCD | DSLR | 76, 38,
19mm | 18,
Camera
5.6, 12.5,
18 | Swing
Arm Stand |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-----------------|--------|-------------------|--------|-------------------|------------------------------|--------------------|
| Optik2-
04-007 | 7.5, 15,
30x | 45° | For 1.0"
CCD | DSLR | 46, 23,
11.5mm | 18,
Camera
7.1, 14, 18 | No Green
Filter |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|--------|------------------|----------------------------------|-----------|
| Optik2-
07-004 | 3.75, 7.5,
15x | 0° | For 1.0"
CCD | DSLR | 76, 38,
19mm | 18,
Camera
5.6, 12.5
18 | Tilt Base |
9
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-----------------|--------|-------------------|--------|-------------------|------------------------------|--------------------|
| Optik2-04-
444 | 7.5, 15,
30x | 0° | For 1.0"
CCD | DSLR | 46, 23,
11.5mm | 18,
Camera
7.1, 14, 18 | Swing
Arm Stand |
Scope Head 3ML, External Photographic Models
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|--------|------------------|----------------------------------|-------------------|
| Optik2-
13-003 | 3.75, 7.5,
15x | 0° | For ".05"
CCD | DSLR | 76, 38,
19mm | 18,
Camera
5.6, 12.5
18 | Swing
Arm Base |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|--------|------------------|----------------------------------|-----------|
| Optik2-
14-008 | 3.75, 7.5,
15x | 0° | For .05"
CCD | DSLR | 76, 38,
19mm | 18,
Camera
5.6, 12.5
18 | Tilt Base |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|--------|------------------|----------------------------------|-----------------|
| Optik2-
15-008 | 3.75, 7.5,
15x | 0° | For .05"
CCD | DSLR | 76, 38,
19mm | 18,
Camera
5.6, 12.5
18 | Upright
Base |
Scope Head 3MV, Integrated Photographic Models
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|-------------------------|------------------|----------------------------------|---------------|
| Optik2-
06-007 | 3.75, 7.5,
15x | 0° | Integrated | 1.3MP
USB
Digital | 76, 38,
19mm | 18,
Camera
5.6, 12.5
18 | Swing
Base |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|-------------------------|------------------|----------------------------------|---------------------|
| Optok2-
07-007 | 3.75, 7.5,
15x | 0° | Integrated | 1.3MP
USB
Digital | 76, 38,
19mm | 18,
Camera
5.6, 12.5
18 | Balance-
O-Matic |
10
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|-------------------------|------------------|-----------------------------------|--------------------|
| Optik2-
13-003 | 3.75, 7.5,
15x | 0° | Integrated | 1.3MP
USB
Digital | 76, 38,
19mm | 18,
Camera
5.6, 12.5,
18 | Swing
Arm Stand |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
| Optik2-
14-003 | 3.75, 7.5,
15x | 0° | Integrated | 1.3MP
USB
Digital | 76, 38,
19mm | 18,
Camera
5.6, 12.5,
18 | Tilt Stand |
Scope Head 3MV, Integrated Photographic Models
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|----------------|------------------|----------------------------------|------------------|
| Optik2-
15-003 | 3.75, 7.5,
15x | 0° | Integrated | USB
Digital | 76, 38,
19mm | 18,
Camera
5.6, 12.5
18 | Rolling
Stand |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|------------------|------------------|---------------------------|--------------------------------|
| Optik2-10 | 3.75, 7.5,
15x | 0° | Integral | S-Video,
NTSC | 76, 38,
19mm | 18,
Camera 4,
9, 16 | Tilt Stand |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
| Optik2-
10-001 | 3.75, 7.5,
15x | 0° | Integral | S-Video,
NTSC | 76, 38,
19mm | 18,
Camera 4,
9, 16 | Tilt Stand
& LCD
monitor |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|------------------|-------------------|--------|-------------------|------------------|------------------|---------------------------|-----------------|
| Optik2-11 | 3.75, 7.5,
15x | 0° | Integral | S-Video,
NTSC | 76, 38,
19mm | 18,
Camera 4,
9, 16 | Upright
Base |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|------------------|------------------|---------------------------|-------------------------------------|
| Optik2-
11-001 | 3.75, 7.5,
15x | 0° | Integral | S-Video,
NTSC | 76, 38,
19mm | 18,
Camera 4,
9, 16 | Upright
Base &
LCD
monitor |
11
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-----------|-------------------|--------|-------------------|------------------|------------------|---------------------------|--------------------|
| Optik2-12 | 3.75, 7.5,
15x | 0° | Integral | S-Video,
NTSC | 76, 38,
19mm | 18,
Camera 4,
9, 16 | Swing
Arm Stand |
Scope Head 3MV, Integrated Photographic Models
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|------------------|------------------|---------------------------|----------------------------------------|
| Optik2-
12-001 | 3.75, 7.5,
15x | 0° | Integral | S-Video,
NTSC | 76, 38,
19mm | 18,
Camera 4,
9, 16 | Swing
Arm Stand
& LCD
monitor |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|------------------|------------------|---------------------------|--------------------------------|
| Optik2-
10-001 | 3.75, 7.5,
15x | 0° | Integral | S-Video,
NTSC | 76, 38,
19mm | 18,
Camera 4,
9, 16 | Tilt Stand
& LCD
Monitor |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|------------------|------------------|---------------------------|----------------------------------------|
| Optik2-
11-001 | 3.75, 7.5,
15x | 0° | Integral | S-Video,
NTSC | 76, 38,
19mm | 18,
Camera 4,
9, 16 | Rolling
Stand &
LCD
Monitor |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
| Optik2-
12-001 | 3.75, 7.5,
15x | 0° | Integral | S-Video,
NTSC | 76, 38,
19mm | 18,
Camera 4,
9, 16 | Swing
Arm Stand
& LCD
Monitor |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|----------------|------------------|----------------------------------|------------|
| Optik2-
14-003 | 3.75,
7.5, 15x | 0° | Integral | USB
Digital | 76, 38,
19mm | 18,
Camera
5.6, 12.5
18 | Tilt Stand |
12
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-------------------|-------------------|--------|-------------------|----------------|------------------|----------------------------------|--------------------|
| Optik2-
15-008 | 3.75, 7.5,
15x | 0° | Integral | USB
Digital | 76, 38,
19mm | 18,
Camera
5.6, 12.5
18 | Upright
base |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
| Optik2-
13-003 | 3.75, 7.5,
15x | 0° | Integral | USB
Digital | 76, 38,
19mm | 18,
Camera
5.6, 12.5
18 | Swing
Arm Stand |
Scope Head 3MV, Integrated Photographic Models
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-----------|-------------------|--------|-------------------|----------------|------------------|----------------------------------|--------------------|
| Optik2-13 | 3.75, 7.5,
15x | 0° | Integral | USB
Digital | 76, 38,
19mm | 18,
Camera
5.6, 12.5
18 | Swing
Arm Stand |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-----------|-------------------|--------|-------------------|----------------|------------------|-----------------------------------|------|
| Optik2-14 | 3.75, 7.5,
15x | 0° | Integral | USB
Digital | 76, 38,
19mm | 18,
Camera
5.6, 12.5,
18 | n/a |
| US Model | Mag | Ocular | Camera
feature | Output | Field of
View | Resolution | Note |
|-----------|-------------------|--------|-------------------|----------------|------------------|-----------------------------------|-----------------|
| Optik2-15 | 3.75, 7.5,
15x | 0° | Integral | USB
Digital | 76, 38,
19mm | 18,
Camera
5.6, 12.5,
18 | Rolling
Base |