(155 days)
Not Found
No
The summary describes standard video signal processing for image enhancement and display, but there is no mention of AI or ML technologies for analysis, interpretation, or decision support.
Yes
The "Intended Use / Indications for Use" section explicitly states that the endoscopes are intended for "endoscopic surgery" and the video system center and light source are for "endoscopic diagnosis, treatment, and video observation," indicating a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices (Video System Center and Light Source) are "intended for endoscopic diagnosis, treatment, and video observation."
No
The device description explicitly lists hardware components such as endoscopes, a video system center, and a light source as primary components of the system. While the video system center contains software for image processing, the device as a whole is a hardware system with integrated software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the device is for "endoscopy and endoscopic surgery," "endoscopic diagnosis, treatment, and video observation," and use within the upper and lower digestive tract. These are all procedures performed in vivo (within a living organism).
- Device Description: The description details components like endoscopes, a video system center, and a light source, all used for visualizing internal body structures.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such tests on in vitro samples.
The device is an endoscopic system used for direct visualization and intervention within the body, which falls under the category of in vivo diagnostic and therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Endoscopes (GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190, COLONOVIDEOSCOPE CF-HQ190L/I, CF-H190L/I, PCF-H190L/I, PCF-PH190L/I)
This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/l), light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190 are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
The EVIS EXERA III COLONOVIDEOSCOPE CF-H190L/I, CF-HQ190L/I, PCF-PH190L/I, PCF-H190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
CV-190 VIDEO SYSTEM CENTER
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
CLV-190 XENON LIGHT SOURCE
This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Product codes (comma separated list FDA assigned to the subject device)
FDF, FDS, NWB
Device Description
The EVIS EXERA III VIDEO SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
The primary components of the subject system, which are part of this submission, are:
- Video System Center OLYMPUS CV-190
- XENON LIGHT SOURCE OLYMPUS CLV-190
- GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190
- COLONOVIDEOSCOPE CF-HQ190L/I, CF-H190L/I, PCF-H190L/I, PCF-PH190L/I
The CV-190 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The OLYMPUS CV-190 allows image display on HDTV (16:9).
The XENON LIGHT SOURCE OLYMPUS CLV-190 is intended for endoscopic diagnosis, treatment and video observation.
In addition, both the CV-190 and CLV-190 can be used with any specified Olympus flexible and rigid including gastroscopes, ultrasound gastroscopes, endoscope models. duodenoscopes. colonoscopes, sigmoidscopes, choledochoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes.
The subject endoscopes could be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/I). light source, document, monitor. EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment within the upper and lower digestive tract.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper digestive tract (esophagus, stomach, duodenum), Lower digestive tract (anus, rectum, sigmoid colon, colon, ileocecal valve)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Reprocessing validation was carried out in accordance with "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996."
The software validation activities were performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."
The following standards have been applied to the EVIS EXERA III 190 SYSTEM :
- IEC 60601-1
- IEC 60601-1-1
- IEC 60601-2-18
- IEC 60601-1-2
- ISO 14971
- ASTM E1837-96 (Reapproved 2007)
- ANSI/AAMI/ISO 11135-1
- ISO 10993-1
- ISO 10993-5
- ISO 10993-10
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.
K100584, K011151, K002749, K051645, K062049
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
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image shows a date, "FEB 16 2012". The month is February, the day is the 16th, and the year is 2012. The text is in a simple, sans-serif font.
K112680
Pages 1 of 5
510(k) SUMMARY
EVIS EXERA III VIDEO SYSTEM ENDOSCOPIC VIDEO IMAGING SYSTEM
January 18, 2012
1 General Information
- Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
- Official Correspondent: Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 FAX: 484-896-7128 Email: stacy.kluesner@olympus.com
- (Endoscopes) Manufacturer: Aizu Olympus Co., Ltd. 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No.: 9610595 (CV-190, CLV-190)
SHIRAKAWA OLYMPUS CO., LTD. 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No: 3002808148
Device Identification 2
| ■ | Device Trade Name: | EVIS EXERA III VIDEO SYSTEM |
|---|---|---|
| ■ | Common Name: | ENDOSCOPIC VIDEO IMAGING SYSTEM |
| ■ | Regulation Number: | 876.1500 |
| ■ | Regulation Name: | Endoscope and Accessories |
| ■ | Regulatory Class: | II |
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1
K112680
pages 2 of 5
- Classification Panel: Gastroenterology and urology ■
- FDF (colonoscope and accessories, flexible/rigid) I Product Code: FDS (gastroscope and accessories, flexible/rigid) NWB (endoscope, accessories, narrow band spectrum)
3 Predicate Device Information
| Subject Device
(Part of this submission) | Predicate Device | Predicate
Device
510(k) No. |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| GASTROINTESTINAL VIDEOSCOPE
OLYMPUS GIF TYPE H190
(GIF-H190) | EVIS EXERA II GASTROINTESTINAL
VIDEOSCOPE
OLYMPUS GIF TYPE H180
(GIF-H180) | K100584 |
| GASTROINTESTINAL VIDEOSCOPE
OLYMPUS GIF TYPE HQ190
(GIF-HQ190) | EVIS EXERA II GASTROINTESTINAL
VIDEOSCOPE
OLYMPUS GIF TYPE H180
(GIF-H180)
EVIS EXERA Gastrointestinal Videoscope
GIF-Q160Z
(Herein after referred to as GIF-Q160Z) | K100584
K011151 |
| COLONOVIDEOSCOPE
OLYMPUS CF TYPE HQ190L
(CF-HQ190L) | EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS CF TYPE H180AL
(CF-H180AL)
EVIS EXERA Gastrointestinal Videoscope
GIF-Q160Z
(Herein after referred to as GIF-Q160Z)
Colonovideoscope XCF-Q140L/I3D
(Herein after referred to as
XCF-Q140L/I3D) | K100584
K011151
K002749 |
| COLONOVIDEOSCOPE
OLYMPUS CF TYPE HQ190I
(CF-HQ190I) | EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS CF TYPE H180AI
(CF-H180AI)
EVIS EXERA Gastrointestinal Videoscope
GIF-Q160Z
(Herein after referred to as GIF-Q160Z)
Colonovideoscope XCF-Q140L/I3D
(Herein after referred to as
XCF-Q140L/I3D) | K100584
K011151
K002749 |
| COLONOVIDEOSCOPE
OLYMPUS CF TYPE H190L
(CF-H190L) | EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS CF TYPE H180AL
(CF-H180AL) | K100584 |
| COLONOVIDEOSCOPE | EVIS EXERA II COLONOVIDEOSCOPE | K100584 |
2
| K112680 |
|---|
| Pages 3 of 5 |
| OLYMPUS CF TYPE H1901
(CF-H190I)
COLONOVIDEOSCOPE
OLYMPUS PCF TYPE PH190L
(PCF-PH190L)
COLONOVIDEOSCOPE
OLYMPUS PCF TYPE PH190I
(PCF-PH190I)
COLONOVIDEOSCOPE
OLYMPUS PCF TYPE H190L
(PCF-H190L)
COLONOVIDEOSCOPE
OLYMPUS PCF TYPE H190I
(PCF-H190I)
OLYMPUS CV-190
VIDEO SYSTEM CENTER
(CV-190)
OLYMPUS CLV-190
XENON LIGHT SOURCE
(CLV-190) | OLYMPUS CF TYPE H180AI
(CF-H180AI)
EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS PCF TYPE H180AL
(PCF-H180AL)
EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS PCF TYPE H180AI
(PCF-H180AI)
EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS PCF TYPE H180AL
(PCF-H180AL)
EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS PCF TYPE H180AI
(PCF-H180AI)
EVIS EXERA Video system Center
OLYMPUS CV-160A
(CV-160A)
EVIS EXERA II VIDEO SYSTEM CENTER
OLYMPUS CV-180
(CV-180)
EVIS EXERA Xenon Light Source
OLYMPUS CLV-160A
(CLV-160A)
EVIS EXERA II XENON LIGHT SOURCE
OLYMPUS CLV-180
(CLV-180) | K100584
K100584
K100584
K100584
K051645
K062049
K100584
K051645
K062049
K100584 |
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------ |
|---|
Device Description 4
The EVIS EXERA III VIDEO SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
The primary components of the subject system, which are part of this submission, are:
- Video System Center OLYMPUS CV-190
- XENON LIGHT SOURCE OLYMPUS CLV-190
- GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190
- COLONOVIDEOSCOPE CF-HQ190L/I, CF-H190L/I, PCF-H190L/I, PCF-PH190L/I
The CV-190 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The OLYMPUS CV-190 allows image display on HDTV (16:9).
The XENON LIGHT SOURCE OLYMPUS CLV-190 is intended for endoscopic diagnosis, treatment and video observation.
Page 3 of 5
3
K112680
pages 4 of 5
In addition, both the CV-190 and CLV-190 can be used with any specified Olympus flexible and rigid including gastroscopes, ultrasound gastroscopes, endoscope models. duodenoscopes. colonoscopes, sigmoidscopes, choledochoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes.
The subject endoscopes could be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/I). light source, document, monitor. EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment within the upper and lower digestive tract.
Indications for Use 5
Endoscopes (GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190, COLONOVIDEOSCOPE CF-HQ190L/I, CF-H190L/I, PCF-H190L/I, PCF-PH190L/I)
This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/l), light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190 are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
The EVIS EXERA III COLONOVIDEOSCOPE CF-H190L/I, CF-HQ190L/I, PCF-PH190L/I, PCF-H190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
CV-190 VIDEO SYSTEM CENTER
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
CLV-190 XENON LIGHT SOURCE
This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Comparison of Technological Characteristics 6
The CV-190 incorporates the following features compared to the predicate device: (1) Provides high quality endoscopic image by using the subject device with new endoscopes and light sources, (2) Noise reduction, (3) Pre-freeze, (4) Brighter and more contrasted NBI observation, (5) Ethernet interface and (6) Color Correction.
The CLV-190 incorporates the following features compared to the predicate device: (1) User friendly new connector, (2) Built-in type power fuse, (3) High-definition images, (4) 1R absorbing filter removed.
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4
K1/2680
Pages 5 of 5
The endoscopes incorporates the following features compared to the predicate device: (1) A new Integrated scope connector that includes both the Light-guide and electronic-contact (video scope connection), (2) Dual Focus switching function, LTA (Long Tail Actuator) is incorporated, (3) Passive Bending / High Force Transmission insertion tube and (4) New nozzle.
7 Summary of non-clinical testing
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Reprocessing validation was carried out in accordance with "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996."
The software validation activities were performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."
The following standards have been applied to the EVIS EXERA III 190 SYSTEM :
- · IEC 60601-1
- · IEC 60601-1-1
- · IEC 60601-2-18
- · IEC 60601-1-2
- · ISO 14971
- · ASTM E1837-96 (Reapproved 2007)
- · ANSI/AAMI/ISO 11135-1
- · ISO 10993-1
- · ISO 10993-5
- · ISO 10993-10
Conclusion 8
When compared to the predicate device, the EVIS EXERA III VIDEO SYSTEM does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.
- 1t
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming its body and wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OLYMPUS MEDICAL SYSTEMS CORP. % Ms. Stacy Abbatiello Kluesner Project Manager Olympus America Inc. 3500 Corporate Parkway PO Box 610 CENTER VALLEY PA 18034
FEB 1 6 2012
Re: K112680
Trade/Device Name: EVIS EXERA III VIDEO SYSTEM Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: January 19, 2012 Received: January 20, 2012
Dear Ms. Kluesner:
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 for answer 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. You must or any - 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
6
Page 2 -
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/Resourcesfor You/Industry/default.htm.
Sincerély yours,
Sincerely yours,
Benjamin R. Tucker
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
7
Indications for Use
510(k) Number (if known):
12680
Device Name:
Indications For Use:
Endoscopes (GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190,
COLONOVIDEOSCOPE CF-HQ190L/I, CF-H190L/I, PCF-H190L/I, PCF-PH190L/I)
This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/l), light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190 are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
The EVIS EXERA III COLONOVIDEOSCOPE CF-H190L/I, CF-HQ190L/I, PCF-PH190L/I, PCF-H190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
CV-190 VIDEO SYSTEM CENTER
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
CLV-190 XENON LIGHT SOURCE
This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Prescription Use_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
: 333331