(44 days)
Not Found
No
The description focuses on standard ultrasound imaging modes, measurements, and storage capabilities, with no mention of AI or ML features.
No
The device is used to observe and store real-time ultrasound images for diagnostic purposes, not to provide treatment.
Yes
The device acquires and displays real-time ultrasound images to observe organs and tissues, including features like B-mode, PWD, Color Doppler, and Elastography, and provides measurements (distance, area, volume, blood velocity) to aid in the assessment of a patient's condition. The "Predicate Device(s)" also includes a "Diagnostic Ultrasound Scanner."
No
The device description explicitly states it is a "system" that "combined with Ultrasound videoscopes or Ultrasound probes" and has various hardware-dependent functions like acquiring and displaying images, providing measurements, and enabling printing and recording. This indicates it is a hardware system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device function: The description clearly states that this device is an "ENDOSCOPIC ULTRASOUND CENTER" that works with ultrasound endoscopes and probes to acquire and display real-time ultrasound images of target organs within the body.
- No mention of specimen analysis: There is no indication that this device analyzes any samples taken from the body. It is used for direct imaging within the body.
Therefore, this device falls under the category of an imaging device used for diagnostic purposes in vivo (within the living body), 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, ITX, IYO, ODG
Device Description
The subject system, EU-Y0008 ENDOSCOPIC ULTRASOUND CENTER, combined 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 Others (3-D Imaging and Harmonic Imaging) and Elastography function which visualizes the amount of strain in tissue (hardness of tissue) during compression and retraction.
The subject system provides measurements and calculations of distance, area, circumference, volume, time and blood velocity and provides 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. Additionally, the subject system enables the user to record movies to internal memory.
The subject system can identify and recognize 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
Yes
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)
Not Found
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
OLYMPUS MEDICAL SYSTEMS CORP. % Daphney Germain-Kolawole Regulatory Affairs Project Manager Olympus America, Inc. 3500 Corporate Parkway, P.O. Box 610 Center Valley, PA 18034-0610
JUL 2 7 2015
Re: K130058
Trade/Device Name: Endoscopic Ultrasound Center EU-Y0008 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, IYO, ODG Dated (Date on orig SE ltr): January 8, 2013 Received (Date on orig SE ltr): January 9, 2013
Dear Daphney Germain-Kolawole,
This letter corrects our substantially equivalent letter of February 22, 2013.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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.
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): _K1300S8
Device Name: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 210(k)
Page 1 of 21
Section1.1 Administrative Information Indications for Use Statement Page 2 of 22
20
3
1.1.4.1 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| General | ||||||||
| (Track 1 Only) | ||||||||
| 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(*2) | N (*3) | N (*4) | |||
| Trans-vaginal | ||||||||
| Trans-urethral | N | N | N(*2) | N (*3) | N (*4) | |||
| Trans-esoph. (non-Card.) | N | N | N(*2) | N (*3) | N (*4) | |||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | N | N | N(*2) | 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, Intraluminal ultrasound for airways and tracheobronchial tree
*2: Includes Power Doppler
*3: Combination of each operating mode, B, PWD, Color Dopoler and Other
*4: 3-D Imaging, Harmonic Imaging
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
Section1.1 Administr: Indications for Use Statement Page 3 of 22
4
1.1.4.2 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | 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 | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| 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
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
Section1.1 Administrative Information Indications for Use Statement Page 4 of 22
5
1.1.4.3 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | 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) | ||||||||
| 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
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 210(K)
Section1.1 Administrative Information Indications for Use Statement Page 5 of 22
6
1.1.4.4 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 Transducer: ULTRASONIC PROBE UM-2R
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined (Specify) | Other (Specify) | ||||||
| (Track 1 Only) | ||||||||
| 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 | P | |||||||
| 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, billiary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)
Section 1. 1 Administrative Information Indications for Use Statement Page 6 of 22
7
1.1.4.5 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 Transducer: ULTRASONIC PROBE UM-3R
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 | 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
(Division Sign Off) Division of Radiological Health Iffice of In Vitro Diagnostic and Radiological Health 510(k)
Section1.1 Administrative Information Indications for Use Statement Page 7 of 22
8
1.1.4.6 Diagnostic Ultrasound Indications For Use Format '
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | 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
Section 1. 1 Administrative Information Indications for Use Statement Page 8 of 22
(Division Sign Off) Division of Radiological Health iffice of In Vitro Diagnostic and Radiological Health 510(k)
9
1.1.4.7 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | 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 | 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
Section1.1 Administrative Information Indications for Use Statement Page 9 of 22
(Division Sign Off) Division of Radiological Health Iffice of In Vitro Diagnostic and Radiological Health 510(k)
10
1.1.4.8 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
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 | 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 | |||||||||
| 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
Section1.1 Administrative Information Indications for Use Statement Page 10 of 22
(Division Sign Off) Division of Radiological Health ffice of In Vitro Diagnostic and Radiological Health 510(k)
11
1.1.4.9 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | Specific | B | M | PWD | CWD | Color | ||
| Doppler | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| (Track 1 Only) (Tracks 1 & 3) | ||||||||
| 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 | ||||||||
| 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 wall ;biliary duct(common bile, cystic, intrahepatic); pancreatic ducts ; and surrounding organs; upper airways and tracheobronchial tree.
Section 1.1 Administrative Information Indications for Use Statement Page 11 of 22
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12
1.1.4.10 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | 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
Section1.1 Administrative Information Indications for Use Statement Page 12 of 22
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13
1.1.4.11 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | 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
Section1.1 Administrative Information Indications for Use Statement Page 13 of 22
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14
1.1.4.12 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined Other | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| General | ||||||||
| (Track 1 Only) | ||||||||
| 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 | P(*2) | ||||||
| Trans-esoph. (non-Card.) | P | P(*2) | ||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P(*2) | ||||||
| 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: 3-D Imaging
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Section1.1 Administrative Information Indications for Use Statement Page 14 of 22
15
1.1.4.13 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | Combined Other | |||||||
| (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 | P(*2) | ||||||
| Trans-vaginal | ||||||||
| Trans-urethral | P | P(*2) | ||||||
| Trans-esoph. (non-Card.) | P | P(*2) | ||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P(*2) | ||||||
| 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: 3-D Imaging
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Section 1. 1 Administrative Information Indications for Use Statement Page 15 of 22
16
1.1.4.14 Diagnostic Uitrasound Indications For Use Format
.
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | Specific | B | M | PWD | CWD | Color . | Combined Other | |
| (Track 1 Only)(Tracks 1 & 3) | Doppler (Specify) | (Specify) | ||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | Adult Cephalic | |||||||
| & Other | Trans-rectal | P | P(*2) | |||||
| Trans-vaginal | ||||||||
| Trans-urethral | D | P(*2) | ||||||
| Trans-esoph. (non-Card.) P | P(*2) | |||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*. 1) | P | P(*2) | ||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Cardiac | Trans-esoph. (Cardiac) | |||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| 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: 3-D Imaging
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Section1.1 Administrative Information Indications for Use Statement Page 16 of 22 .
17
1.1.4.15 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
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 | 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 | |||||||
| 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
Section1.1 Administrative Information Indications for Use Statement Page 17 of 22
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35
18
1.1.4.16 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other (Specify) | ||
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | ||||||||
| 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(*2) | P(*3) | P(*4) | |||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P(*2) | P(*3) | P(*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: 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
Section1.1 Administrative Information Indications for Use Statement Page 18 of 22
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19
1.1.4.17 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | 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(*2) | P(*3) | P(*4) | |||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P(*2) | P(*3) | P(*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
Section1.1 Administrative Information Indications for Use Statement Page 19 of 22
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20
1.1.4.18 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 Transducer: ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| General | ||||||||
| (Track 1 Only) | (Tracks 1 & 3) | |||||||
| 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(*2) | P(*3) | ||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P(*2) | P(*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
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Section1.1 Administrative Information Indications for Use Statement Page 20 of 22
21
1.1.4.19 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 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 | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other | |||||||
| (Specify) | ||||||||
| General | ||||||||
| (Track 1 Only) | ||||||||
| 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(*2) | P(*3) | ||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P(*2) | P(*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
Section1.1 Administrative Information Indications for Use Statement Page 21 of 22
(Division Sign Off) Division of Radiological Health. Iffice of In Vitro Diagnostic and Radiological Health 510(k)
22
1.1.4.20 Diagnostic Ultrasound Indications For Use Format
System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
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 | 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(*2) | P(*3) | P(*4) | |||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) (*1) | P | P | P(*2) | P(*3) | P(*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
42: Includes Power Doppler
*3: Combination of each operating mode, B, PWD, Color Doppler and Other
*4: Harmonic Imaging
Smir
Section 1. 1 Administrative Information Indications for Use Statement Page 22 of 22
(Division Sign Off) Division of Radiological Health Iffice of In Vitro Diagnostic and Radiological Health K130058