ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
Device Facts
| Record ID | K130058 |
|---|---|
| Device Name | ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 |
| Applicant | Olympus Medical Systems Corp. |
| Product Code | IYN · Radiology |
| Decision Date | Feb 22, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
Intended 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.
Device Story
The EU-Y0008 Endoscopic Ultrasound Center is a diagnostic ultrasound system used with compatible Olympus ultrasound endoscopes and probes. It acquires, displays, and stores real-time ultrasound images of internal organs and structures. The system supports B-mode, PWD, Color Doppler, 3D imaging, harmonic imaging, and elastography (visualizing tissue strain/hardness). It also performs measurements of distance, area, circumference, volume, time, and blood velocity. The device is operated by clinicians in a clinical setting to assist in diagnostic procedures. It provides image storage, retrieval, and printing capabilities, and can record movies to internal memory. The system identifies connected transducers and can display endoscopic images alongside ultrasound data. By providing high-resolution, real-time visualization and quantitative measurements, the device aids clinicians in assessing tissue characteristics and blood flow, supporting clinical decision-making during endoscopic examinations.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Diagnostic ultrasound system supporting B-mode, PWD, Color Doppler, 3D imaging, harmonic imaging, and elastography. Features include TIC (Time Intensity Curve) analysis and movie storage. Compatible with various Olympus ultrasound endoscopes and probes. Designed to meet applicable safety standards for ultrasonic pulsed doppler and echo imaging systems.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis within the gastrointestinal tract, biliary and pancreatic ducts, surrounding organs, airways, tracheobronchial tree, and urinary tract.
Regulatory Classification
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.
Predicate Devices
- ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 (K121564)
- HI VISION Preirus Diagnostic Ultrasound Scanner (K093466)
Related Devices
- K121564 — ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 · Olympus Medical Systems Corp. · Oct 16, 2012
- K243502 — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) · Olympus Medical Systems Corporation · Jan 17, 2025
- K203128 — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS · Olympus Medical Systems Corp. · Nov 9, 2020
- K200850 — Fujifilm Ultrasonic Processor · Fujifilm Corporation · Jul 6, 2020
- K010591 — OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER · Olympus Optical Co., Ltd. · Mar 15, 2001
Submission Summary (Full Text)
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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
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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
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### 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
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### 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<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| General<br>(Track 1 Only) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(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<br>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
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### 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>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
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### 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>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
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### 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<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined (Specify) | Other (Specify) |
| (Track 1 Only) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) (*1) | P | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>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
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### 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) (*1) | P | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>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
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### 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) (*1) | | P | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>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)
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### 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined Other<br>(Specify) (Specify) |
| Ophthalmic | Ophthalmic | | | | | | |
| Fetal Imaging<br>& 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<br>(Conventional) | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | |
| | Intravascular | | | | | | |
| | Other (Specify) (*1) | P | | | | | |
| Cardiac | Cardiac Adult | | | | | | |
| | Cardiac Pediatric | | | | | | |
| | Intravascular (Cardiac) | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | |
| | Intra-cardiac | | | | | | |
| | Other (Specify) | | | | | | |
| Peripheral<br>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)
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### 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& 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<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Specify) (*1) | P | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>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)
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### 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<br>Doppler | Combined<br>(Specify) | Other<br>(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<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | P | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | P | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) (*1) | | P | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| | | | | | | | | |
| Peripheral<br>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
(Division Sign Off) Division of Radiological Health office of In Vitro Diagnostic and Radiological Health 210(K)
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### 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) (*1) | P | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>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
(Division Sign Off) Division of Radiological Health office of In Vitro Diagnostic and Radiological Health 510(k)
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### 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) (*1) | P | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>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
(Division Sign Off) Division of Radiological Health ffice of In Vitro Diagnostic and Radiological Health 510(k)
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### 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<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined Other<br>(Specify) | Other<br>(Specify) |
| General<br>(Track 1 Only) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) (*1) | | P | | | | | P(*2) |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>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
(Division Sign Off) Division of Radiological Health iffice of In Viro Diagnostic and Radiological Health 510(K) --
Section1.1 Administrative Information Indications for Use Statement Page 14 of 22
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### 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined Other<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | |…
