ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
Device Facts
| Record ID | K121564 |
|---|---|
| Device Name | ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 |
| Applicant | Olympus Medical Systems Corp. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 16, 2012 |
| 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-Y0006 Endoscopic Ultrasound Center is a diagnostic ultrasound system used with compatible Olympus ultrasound endoscopes and probes. It acquires, processes, and displays real-time ultrasound images (B-mode, PWD, Color Doppler, 3D, and Harmonic Imaging) and endoscopic video. The system performs measurements and calculations of distance, area, circumference, volume, time, and blood velocity. It allows for image storage, retrieval, printing, and recording to external devices. Used in clinical settings by physicians, the system aids in visualizing target organs to support clinical decision-making and diagnostic procedures. It identifies compatible transducers automatically and integrates ultrasound and endoscopic views.
Clinical Evidence
No clinical studies were required to support the determination of substantial equivalence. Evidence is based on bench testing, including electrical, thermal, and EMC safety, and acoustic output measurements compliant with NEMA UD2-2004 and NEMA UD3-2004.
Technological Characteristics
Diagnostic ultrasound system; modes: B, PWD, Color Doppler, 3D, Harmonic Imaging. Complies with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-2-18, ISO 14971, NEMA UD2-2004, and NEMA UD3-2004. Connectivity includes external recording and printing. Software is classified as Moderate Level of Concern.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis within the GI 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
- XEU-M60A ENDOSCOPIC ULTRASOUND CENTER (K063683)
- HITACHI HI VISION Preirus Diagnostic Ultrasound Scanner (K093466)
Related Devices
- K130058 — ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 · Olympus Medical Systems Corp. · Feb 22, 2013
- 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
- K243502 — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) · Olympus Medical Systems Corporation · Jan 17, 2025
- K010591 — OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER · Olympus Optical Co., Ltd. · Mar 15, 2001
- K063683 — OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE · Olympus Medical Systems Corporation · Feb 8, 2007
Submission Summary (Full Text)
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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
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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 (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
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### 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
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#### 1.3.1 Diagnostic Ultrasound Indications For Use Format
### System: ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|--------------------------|-----------------------|--------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(*2) | 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 | 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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(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<br>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
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# 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(*2) | 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) (*1) | | | | | | | |
| 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
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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler (*2) | 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) (*1) | | | | | | | |
| 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
21
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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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(*2) | 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
*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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler (*2) | 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 | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| Cardiac | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| Peripheral<br>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<br>(Track 1 Only) (Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(*2) | 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 | 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
*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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(*2) | 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 | 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 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
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{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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(*2) | 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
*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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(*2) | 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.) | 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 wall ;biliary duct(common bile, cystic, intrahepatic); pancreatic ducts ; and surrounding organs; upper airways and trachecbronchial tree.
*2: Includes Power Doppler
510K
*(Division Sign-Off)*
(Division Sign-Off)
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5121564
{12}------------------------------------------------
### 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(*2) | 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 | 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
*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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(*2) | 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
*2: Includes Power Doppler
---
(Division Sign-Off)
Sign-Off Righton of Radiological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices Evaluation and Safaty
510K K121564
**29**
{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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(*2) | 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 | | | | | | N(*3) |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | P | | | | | | N(*3) |
| | Trans-esoph. (non-Card.) | P | | | | | | N(*3) |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) (*1) | P | | | | | | N(*3) |
| 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: 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler<br>(*2) | 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 | | | | | | N(*3) |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | P | | | | | | N(*3) |
| | Trans-esoph. (non-Card.) | P | | | | | | N(*3) |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) (*1) | P | | | | | | N(*3)…
