(140 days)
Not Found
No
The document describes a standard ultrasound imaging system with various modes and measurement capabilities. There is no mention of AI, ML, or any related concepts like image processing that would typically indicate the presence of such technology. The performance studies section also indicates no clinical studies were required, which is less common for devices with novel AI/ML algorithms.
No
The device is used to observe and acquire real-time ultrasound images for diagnostic purposes, not for treatment.
Yes
The device is described as an "ENDOSCOPIC ULTRASOUND CENTER" that acquires and displays "real-time ultrasound images of the target organs" and "provides measurements and calculations of distance, area, circumference, volume, time and blood velocity". It also mentions the ability to store and retrieve images for review. Furthermore, one of its predicate devices, K093466, is explicitly named "HITACHI HI VISION Preirus Diagnostic Ultrasound Scanner," which directly implies a diagnostic purpose.
No
The device description explicitly states it is a "system" that "combines with Ultrasound videoscopes or Ultrasound probes" and has various hardware components and functionalities like displaying images, measurements, storage, and printing. This indicates it is a hardware-based system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that this ultrasound center is used to observe and store real-time ultrasound images within the body (gastrointestinal tract, airways, urinary tract, etc.). It is an imaging device used in vivo, not for testing samples in vitro.
- The device description focuses on imaging modalities and measurements of physical characteristics. It describes B-mode, Doppler, measurements of distance, area, volume, etc., which are typical for ultrasound imaging systems used for anatomical visualization and assessment.
- There is no mention of analyzing biological samples or performing tests on bodily fluids or tissues.
Therefore, this device falls under the category of a medical imaging device used for diagnostic purposes in vivo, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This ultrasound center is intended to be used with Olympus ultrasound endoscopes, Olympus ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time ultrasound images and indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree, and urinary tract.
Product codes
IYN, IYO, ITX, ODG
Device Description
The subject system EU-Y0006 ENDOSCOPIC ULTRASOUND CENTER combines with Ultrasound videoscopes or Ultrasound probes to make an endoscopic ultrasound imaging system that can acquire and display high-resolution and high-penetration, real-time ultrasound images of the target organs.
The subject system has modes of B, PWD, Color Doppler, Combined and Other (3-D Imaging and Harmonic Imaging).
The subject system provides measurements and calculations of distance, area, circumference, volume, time and blood velocity, providing for the storage and retrieval of images for review and printing. The subject system enables the user to print images and record images to external recording devices.
The subject system can identify and recognize the compatible Olympus transducers and display endoscopic images in addition to ultrasound images.
The basic design; system configuration, general operation and user interface of this subject system are substantially equivalent to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree, and urinary tract.
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)
The FEU-Y0006 - ENDOSCOPIC ULTRASOUND CENTER has been evaluated for electrical, thermal, and EMC safety. The acoustic output exposure levels will be measured, calculated and derated following the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and in all cases, the acoustic output does not exceed derated ISPTA of 720 mW/cm² and MI of 1.9.
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.
Software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Moderate Level of Concern."
The ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 did not require dinical studies to support the determination of substantial equivalence.
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
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, representing health and well-being. The figure is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 27 2015
Olympus Medical Systems Corporation % Ms. Laura Storms-Tyler Vice President, Regulatory Affairs & Ouality Assurance Olympus America, Inc. 3500 Corporate Parkway, PO Box 610 Center Valley, PA 18034-0610
Re: K121564
Trade/Device Name: Endoscopic Ultrasound Center EU-Y0006 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and ODG Dated (Date on orig SE ltr): September 18, 2012 Received (Date on orig SE ltr): September 19, 2012
Dear Ms. Storms-Tyler,
This letter corrects our substantially equivalent letter of October 16, 2012.
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
1
Page 2 -
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 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 contact 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. 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/Safetw/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,
Benjamin R. Fisher -S
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 Form
510(k) Number (if known): Device Name: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Indications for Use:
This ultrasound center is intended to be used with Olympus ultrasound endoscopes, Olympus ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time ultrasound images and indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree, and urinary tract.
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 In Vitro Diagnostic Devices (OIVD)
Arnold O'Brien
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121564
Page 1 of _ 1
3
1.3.1 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N (*3) | N (*4) | |||
| Trans-vaginal | ||||||||
| Trans-urethral | N | N | N | N (*3) | N (*4) | |||
| Trans-esoph. (non-Card.) N | N | N | N (*3) | N (*4) | ||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (* 1) | N | N | N | N (*3) | N (*4) | |||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
. Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for airways and tracheobronchial tree
*2: Includes Power Doppler
*3: Combination of each operating mode, B, PWD, Color Doppler and Other
*4: 3-D Imaging, Harmonic Imaging
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K121564
19
4
1.3.2 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE RU-75M-R1
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel. | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
20
H
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, billiary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
5
1.3.3 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE RU-12M-R1
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
21
ંત્ર ン
し
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Salaty
510K. K121564
6
1.3.4 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-2R
Intended Use: Diagnostic uttrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | |||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | |||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
`Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Sefety
510K. K121564
ન્દ્ર, 41
7
1.3.5 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-3R
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | |||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | |||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Cardiac | Trans-esoph. (Cardiac) | |||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication: P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, billiary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
23
ಿಗೆ
ﺎ ﺗﺄﺛﻴﺮ ﻣﻦ ﺃﻳﻀﺎ ﻓﻲ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
8
1.3.6 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-S20-20R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | |||||||
| (Track 1 Only) (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | |||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | |||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
9
1.3.7 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer. ULTRASONIC PROBE UM-G20-29R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | |||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal. | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | |||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper ainways and tracheobronchial tree
*2: Includes Power Doppler
(Division Sign-Off)
Division of Radiological Devices Evaluation Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
25
। O
10
1.3.8 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-BS20-26R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | |||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | |||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
Division of Radiological Devices Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
11
1.3.9 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-S20-17S
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | |||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication: P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract wall ;biliary duct(common bile, cystic, intrahepatic); pancreatic ducts ; and surrounding organs; upper airways and trachecbronchial tree.
*2: Includes Power Doppler
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1.3.10 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-S30-20R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | |||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | |||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs,
Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
13
1.3.11 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-S30-25R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | |||||||
| Trans-esoph. (non-Card.) | P | |||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (* 1) | P | |||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Intraluminal ultrasound for Gastrointestinal tract and surrounding organs, upper airways and tracheobronchial tree
*2: Includes Power Doppler
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14
1.3.12 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-DP12-25R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | N(*3) | ||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | N(*3) | ||||||
| Trans-esoph. (non-Card.) | P | N(*3) | ||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | N(*3) | ||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
- *2: Includes Power Doppler
*3: 3-D Imaging
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
ાર્ગ
15
1.3.13 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer. ULTRASONIC PROBE UM-DP20-25R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | N(*3) | ||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | N(*3) | ||||||
| Trans-esoph. (non-Card.) | P | N(*3) | ||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | N(*3) | ||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs,
Intraluminal ultrasound for upper airways and tracheobronchial tree
*2: Includes Power Doppler
*3: 3-D Imaging
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Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
s10K K121564
16
1.3.14 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC PROBE UM-DG20-31R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | N(*3) | ||||||
| & Other | Trans-vaginal | |||||||
| Trans-urethral | P | N(*3) | ||||||
| Trans-esoph. (non-Card.) | P | N(*3) | ||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| & Other | Intravascular | |||||||
| & Other | Other (Specify) (*1). | P | N(*3) | |||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs
*2: Includes Power Doppler
*3: 3-D Imaging
Mhhal D Vok
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Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
Additional Comments:
17
1.3.15 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
Transducer. EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM160
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | |||||||||
| (*2) | Combined | ||||||||
| (Specify) | Other | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | P | ||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) (*1) | P | ||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs
*2: Includes Power Doppler
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
S10K: K121564
18
1.3.16 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer. EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180F
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | P | P | P | P | N (*3) | N (*4) | ||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P | P | N (*3) | N (*4) | ||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments: 1
*1: Specification for "Other"
Intraluminal ultrasound for airways and tracheobronchial tree
*2: Includes Power Doppler
*3: Combination of each operating mode, B, PWD, Color Doppler and Other
*4: Harmonic Imaging
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K.K121564
19
1.3.17 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | P | P | P | N (*3) | N (*4) | |||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P | N (*3) | N (*4) | |||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs
*2: Includes Power Doppler
*3: Combination of each operating mode, B, PWD, Color Doppler and Other
*4: Harmonic Imaging
(Division Sign-Off)
Division of Rediological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K121564
35
20
1.3.18 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer: ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (*2) | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | P | P | P | N (*3) | ||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P | N (*3) | ||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication: P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs
*2: Includes Power Doppler
*3: Combination of each operating mode, B, PWD and Color Doppler
(Division Sign-Off)
Division of Radiological Devices Office of the Diagnostic Device Evaluation and Safety
510K K121564
21
1.3.19 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Transducer. ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT140-AL5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| General | |||||||
| (Track 1 Only) | Specific | ||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | ||
| (*2) | Combined Other | ||||||
| (Specify) (Specify) | |||||||
| Ophthalmic | Ophthalmic | ||||||
| Fetal Imaging | |||||||
| & Other | Fetal | ||||||
| Abdominal | |||||||
| Intra-operative (Specify) | |||||||
| Intra-operative (Neuro) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (Specify) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | P | P | P | N (*3) | |||
| Musculo-skeletal | |||||||
| (Conventional) | |||||||
| Musculo-skeletal | |||||||
| (Superficial) | |||||||
| Intravascular | |||||||
| Other (Specify) (*1) | P | P | P | N (*3) | |||
| Cardiac | Cardiac Adult | ||||||
| Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | |||||||
| Intra-cardiac | |||||||
| Other (Specify) | |||||||
| Peripheral | |||||||
| Vessel | Peripheral vessel | ||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs
*2: Includes Power Doppler
*3: Combination of each operating mode, B, PWD and Color Doppler
(Division Sign-Off)
Division of Radiological Devices Office of the Vit o Diagnostic Device Evaluation and Safety
510K K121564
ים חו
22
1.3.20 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
Transducer. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| General | |||||||
| (Track 1 Only) | Specific | ||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||
| Doppler | |||||||
| (*2) | Combined Other | ||||||
| (Specify) (Specify) | |||||||
| Ophthalmic | Ophthalmic | ||||||
| Fetal Imaging | |||||||
| & Other | Fetal | ||||||
| Abdominal | |||||||
| Intra-operative (Specify) | |||||||
| Intra-operative (Neuro) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (Specify) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | P | P | P | N (*3) N (*4) | |||
| Musculo-skeletal | |||||||
| (Conventional) | |||||||
| Musculo-skeletal | |||||||
| (Superficial) | |||||||
| Intravascular | |||||||
| Other (Specify) (*1) | P | P | P | N (*3) N (*4) | |||
| Cardiac | Cardiac Adult | ||||||
| Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | |||||||
| Intra-cardiac | |||||||
| Other (Specify) | |||||||
| Peripheral | |||||||
| Vessel | Peripheral vessel | ||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional Comments:
*1: Specification for "Other"
Gastrointestinal tract and surrounding organs
*2: Includes Power Doppler
*3: Combination of each operating mode, B, PWD, Color Doppler and Other
*4: Harmonic Imaging
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Division of Radiological Device Evaluation and Safety
510K K121564
x3
23
OCT 1 6 2012
510(k) SUMMARY
April 10, 2012
1 General Information
1.1 Manufacture's Name:
.. . . . .
OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
Address:
34-3 Hirai Hinode-Machi, Nishitama-gun, Tokyo, Japan 190-0182
Corresponding Official: Laura Storms-Tyler Olympus America Inc.
... .. . . . . . . . . . . . . . .
r
Address:
3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Laura. Storms-Tyler@olympus.com
OLYMPUS MEDICAL SYSTEMS CORP.
Telephone:
484-896-5688
484-896-7128
Facsimile: west with and so and wo ... ﺎﺳﺘﻦ E-mail:
Applicant's Name:
Address:
1.2
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 ﺤﺮ ﻣﺎ،
Initial Distributor Name/Title/Firm:
Address:
3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Telephone:
484-896-5688
Olympus America Inc.
.....
... .. ... ... .. .. .. .. .. .. . . . . . . . .
24
2 Device Identification
- Device Trade Name:
ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
| Common Name: | Diagnostic Ultrasound System | |
|---|---|---|
| Regulation Number: | 892.1550 Ultrasonic pulsed doppler imaging system | |
| 892.1560 Ultrasonic pulsed echo imaging system | ||
| 876.1500 Endoscope and Accessories | ||
| 892.1570 Diagnostic ultrasound transducer | ||
| Regulatory Class: | II | |
| Product Code: | IYN. IYO. KOG. ITX |
3 Predicate Device Information
- Ultrasound System
| Subject device | Predicate device | ||
|---|---|---|---|
| Name | Manufacturer | 510(k)- | |
| number | |||
| EU-Y0006 | |||
| ENDOSCOPIC | |||
| ULTRASOUND CENTER | XEU-M60A | ||
| ENDOSCOPIC | |||
| ULTRASOUND CENTER | OLYMPUS | ||
| MEDICAL | |||
| SYSTEMS CORP. | K063683 | ||
| HITACHI HI VISION Preirus | |||
| Diagnostic Ultrasound | |||
| Scanner | Hitachi Medical | ||
| Corporation | K093466 |
4 Device Description ------------------
The subject system EU-Y0006 ENDOSCOPIC ULTRASOUND CENTER combines with Ultrasound videoscopes or Ultrasound probes to make an endoscopic ultrasound imaging system that can acquire and display high-resolution and high-penetration, real-time ultrasound images of the target organs.
The subject system has modes of B, PWD, Color Doppler, Combined and Other (3-D Imaging and Harmonic Imaging).
The subject system provides measurements and calculations of distance, area, circumference, volume, time and blood velocity, providing for the storage and retrieval of
25
images for review and printing. The subject system enables the user to print images and record images to external recording devices.
The subject system can identify and recognize the compatible Olympus transducers and display endoscopic images in addition to ultrasound images.
The basic design; system configuration, general operation and user interface of this subject system are substantially equivalent to the predicate devices.
5_Indications for Use
This ultrasound center is intended to be used with Olympus ultrasound endoscopes, Olympus ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time ultrasound images and indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree, and urinary tract.
6 Comparison of Technological Characteristics
The subject system EU-Y0006 ENDOSCOPIC ULTRASOUND CENTER is comparable with and substantially equivalent to the XEU-M60A ENDOSCOPIC ULTRASOUND CENTER (K063683) and the Diagnostic Ultrasound Scanner HITACHI HI VISION Preirus (K093466).
The subject system has same technological characteristics, key features, indications for use, and operation modes as the predicate devices.
The EU-Y0006 differs from the predicate device, XEU-M60A (K033683), in that it contains two new modes, Tissue Harmonic Imaging (THE) and Pulse Wave Doppler (PW) for However, the predicate device, Hitachi HI VISION Preirus ultrasound observation. (K093466) contains these two modes.
7 Summary of non-clinical testing
The FEU-Y0006 - ENDOSCOPIC ULTRASOUND CENTER has been evaluated for electrical, thermal, and EMC safety. The acoustic output exposure levels will be
26
. ... ........................................................................................................................................................................ will was and to will be would and a w
measured, calculated and derated following the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and in all cases, the acoustic output does not exceed derated ISPTA of 720 mW/cm² and MI of 1.9.
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.
Software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Moderate Level of Concern."
The ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 is designed to comply with the followiñg standaïds: 300 mar ... ... ... .
-IEC 60601-1: 1988, Amendment 1: 1991, Amendment 2: 1995
- . -IEC 60601-1-1: 2000
- -IEC 60601-1-2: 2007
- -IEC 60601-2-37: 2001, Amendment 1: 2004, Amendment 2: 2005
- -IEC 60601-2-18: 1996, Amendment 1: 2000
- -ISO 14971: 2007
- -NEMA UD3-2004
- -NEMA UD2-2004
8 Summary of clinical testing
The ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 did not require dinical studies to support the determination of substantial equivalence.
9 Conclusion
When compared to the predicate device, the ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 does not incorporate any significant changes in intended use, method of operation, or design that could affect the safety or effectiveness of the device.