(13 days)
Not Found
No
The summary describes a standard ultrasound imaging system and does not mention any AI or ML capabilities.
No
The device is described as a "Diagnostic ultrasound imaging" system used to acquire and display images, indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body".
No
The device description explicitly states it is an "ENDOSCOPIC ULTRASOUND CENTER" and describes the acquisition and display of images, implying the presence of hardware components beyond just software. It also mentions sound waves being reflected back to a transducer, which is a hardware component of an ultrasound system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Function: This device is an endoscopic ultrasound system. It uses ultrasound waves to create images within the human body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body," and lists various anatomical sites within the body.
- Device Description: The description confirms it's an "endoscopic ultrasound imaging system used to acquire and to display... real-time ultrasound B-mode 2D and 3D images."
The device is a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended uses of the EU-M60, as defined by FDA guidance documents, are:
Transesophageal
Transrectal
Transvaginal
Transurethral
Other
- Gastrointestinal tract, biliary, pancreatic duct and the surrounding Organs
- Intraluminal ultrasound for upper airways and tracheobronchial tree
- Urinary tract
- Female reproductive tract
- 3D imaging
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Transesophageal (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging)
Transrectal (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging)
Transvaginal (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging)
Transurethral (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging)
Other (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging):
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.
Intraluminal ultrasound for upper airways and tracheobronchial tree
Urinary tract
Female reproductive tract:
For OLYMPUS GF TYPE UM160 Ultrasonic Gastrovideoscope:
Transesophageal (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging)
Other (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging):
Gastrointestinal fract billiary, pancreatic duct and surrounding organs,
For OLYMPUS UM-DP12/20-35R Ultrasonic Probes:
Transesophageal (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging)
Transrectal (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging)
Transvaginal (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging)
Transurethral (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging)
Other (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging):
Gastrointestinal tract, biliary, pancreatic duct and surround organs
Intraluminal ultrasound for upper airways and tracheobronchial tree
Urinary tract
Female reproductive tract:
For OLYMPUS UM-2R/3R Ultrasonic Probes:
Transesophageal (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging)
Transrectal (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging)
Transvaginal (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging)
Transurethral (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging)
Other (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging):
Gastrointestinal tract, biliary, pancreatic duct and surround organs
Intraluminal ultrasound for upper airways and tracheobronchial tree
Urinary tract
Female reproductive tract:
For OLYMPUS GF UM130 Ultrasound Gastrovideoscope:
Transesophageal (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging)
Other (previously cleared by FDA in K011886, added under Appendix E for 3D Imaging):
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs,
Product codes (comma separated list FDA assigned to the subject device)
78KOG, 90IYO, ITX
Device Description
The OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER makes a endoscopic ultrasound imaging system used to acquire and to display high-resolution and high-penetration, real-time ultrasound B-mode 2D and 3D images.
The EU-M60 is designed to comply with the standards listed below.
IEC 60601-1 1988 : Amendment 1 (1992) and Amendment (1995)
IEC 60601-1-1 2000
IEC 60601-1-2 1993
IEC 60601-2-18 1996
CISPR11 1990
This device operates identically to the predicate devices in that the transducer of the endoscope or the ultrasonic probe that is inserted into the body cavity mechanically scans the targeted site. The piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images.
Technological Characteristics of this device is identical to the predicated devices identified in item C.
Mentions image processing
Yes, "processed and displayed as images."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Gastrointestinal tract, biliary, pancreatic duct and the surrounding Organs, Intraluminal ultrasound for upper airways and tracheobronchial tree, Urinary tract, Female reproductive tract. Specific applications include Transesophageal, Transrectal, Transvaginal, Transurethral.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
K0+3275
DEC = 9 2004
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.
A. GENERAL INFORMATION
-
- Applicant: Olympus Medical Systems Corp. (Former Name: Olympus Corporation) Hinode Plant Address: 34-3 Hirai, Hinode-machi, Nishitama-gun Tokyo, Japan, 190-0182 Establishment Registration No.: 3003637092
| 2. Submission Correspondent: Takashi Yagi | |
|---|---|
| Olympus Medical Systems Corp. | |
| (Former Name: Olympus Corporation) | |
| Address: | 2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507, Japan |
| Telephone: | 81-426-42-2891 |
| Facsimile: | 81-426-42-3174 |
| E-mail address: | takashi_yagi@ot.olympus.co.jp |
| Establishment Registration No.: | 8010047 |
| 3. Official Correspondent: | Laura Storms-Tyler |
|---|---|
| Title: | Director, Regulatory Affairs and Quality Assurance |
| OLYMPUS AMERICA INC. | |
| Address: | Two Corporate Center Drive, Melville, NY 11747-9058 |
| Telephone: | 631-844-5688 |
| Facsimile: | 631-844-5554 |
| E-mail address: | Laura.Storms-Tyler@olympus.com |
| Establishment Registration No.: | 2429304 |
B. Device Name, Common Name
-
- Common/Usual Name
Diagnostic Ultrasound System with Accessories
- Common/Usual Name
-
- Device Name
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER
- Device Name
3.Classification Name
| FR Number | Product Code | Class | |
|---|---|---|---|
| Endoscope and accessories | 876.1500 | 78KOG | II |
| Ultrasonic pulsed echo imaging system | 892.1560 | 90IYO | II |
C. Identification of the predicate or legally marketed device
The following devices information demonstrates that this device is considered substantially equivalent to a legally marketed, predicate medical device.
1
1. Ultrasound System
| Device Name | #K |
|---|---|
| OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER | K011886 |
| ATL HDI 5000 Ultrasound System | K961459 |
D. Device Description
1. Summary
The OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER makes a endoscopic ultrasound imaging system used to acquire and to display high-resolution and high-penetration, real-time ultrasound B-mode 2D and 3D images.
2. Design
The EU-M60 is designed to comply with the standards listed below.
| IEC 60601-1 | 1988 : Amendment 1 (1992) and Amendment (1995) |
|---|---|
| IEC 60601-1-1 | 2000 |
| IEC 60601-1-2 | 1993 |
| IEC 60601-2-18 | 1996 |
| CISPR11 | 1990 |
E. Intended Use:
The intended uses of the EU-M60, as defined by FDA guidance documents, are:
| Transesophageal | Transrectal |
|---|---|
| Transvaginal | Transurethral |
| Other | |
| 1) Gastrointestinal tract, biliary, pancreatic duct and the surrounding Organs | |
| 2) Intraluminal ultrasound for upper airways and tracheobronchial tree | |
| 3) Urinary tract | |
| 4) Female reproductive tract | |
| 5) 3D imaging |
F. Technological Characteristics:
This device operates identically to the predicate devices in that the transducer of the endoscope or the ultrasonic probe that is inserted into the body cavity mechanically scans the targeted site. The piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images.
Technological Characteristics of this device is identical to the predicated devices identified in item C.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 2004
Olympus Medical Systems Corp. % Mr. N. E. Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548
Re: K043275
Trade Name: Olympus EU-M60 EUS EXERA Endoscopic Ultrasound Center Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Product Code: 78 KOG Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II
Product Code: 90 IYO and ITX
Dated: November 23, 2004
Received: November 26, 2004
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device ' referenced above and we 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). 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.
: This determination of substantial equivalence applies to the following transducers intended for use with the Olympus EU-M60 EUS EXTERA Endoscopic Ultrasound Center, as described in vour premarket notification:
Transducer Model Number
GF Type UM160 UM-DP12/20-35R
UM-2R/3R GF UM 130
3
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or mply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Marv Sacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David le. Lazaro
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
4
4.3.1 Indications for Use Form for 4.5.1 maileations for SSC Formal :
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER
Diagnostic Ultrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | P | Note2(E) | |||||||||
| Transrectal | P | Note2(E) | |||||||||
| Transvaginal | P | Note2(E) | |||||||||
| Transurethral | P | Note2(E) | |||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) | |||||||||||
| Note1 | P | Note2(E) |
Other (specif)
N= new indication; P= previously cleared by FDA in K011886; E= added under Appendix E
Additional Comments:
| Note1: Specification for "Other": |
|---|
| Gastrointestinal tract, biliary, pancreatic duct and surrounding organs. |
| Intraluminal ultrasound for upper airways and tracheobronchial tree |
| Urinary tract |
| Female reproductive tract: |
| Note2:3D Imaging |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Seymour
(Division Sion-Off Division and Radiolor 510(k) Num
5
4.3.2 Indications for U se Form for EUS EXERA Ultrasonic Gastrovideoscope OLYMPUS GF TYPE UM160
Diagnostic Ultrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | P | Note2(E) | ||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) | Note1 | P | Note2(E) |
N= new indication; P= previously cleared by FDA in K011886; E= added under Appendix E
Additional Comments:
Note1: Specification for "Other"
Gastrointestinal fract billiary, pancreatic duct and surrounding organs, Note2:3D Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Daniel A. Legum
(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devices 510(k) Number _
6
4.3.3 Indications for U se Form for OLYMPUS UM-DP12/20-35R Ultrasonic Probes
Diagnostic Uitrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | P | Note2(E) | |||||||||
| Transrectal | P | Note2(E) | |||||||||
| Transvaginal | P | Note2(E) | |||||||||
| Transurethral | P | Note2(E) | |||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) | |||||||||||
| Note1 | P | Note2(E) |
Other (epocition; P= previously cleared by FDA in K011886; E= added under Appendix E
Additional Comments:
Note1: Specification for "Other" :
| Gastrointestinal tract, biliary, pancreatic duct and surround organs |
|---|
| Intraluminal ultrasound for upper airways and tracheobronchial tree |
| Urinary tract |
| Female reproductive tract: |
| Note2:3D Imaging |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David Ch. Seegman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
7
4.3.4 Indications for U se For OLYMPUS UM-2R/3R Ultrasonic Probes
Diagnostic Ultrasound Indications for Use Form
intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined | |||||||||||
| (specify) | Other | |||||||||||
| (specify) | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative | ||||||||||||
| Neurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | P | Note2(E) | ||||||||||
| Transrectal | P | Note2(E) | ||||||||||
| Transvaginal | P | Note2(E) | ||||||||||
| Transurethral | P | Note2(E) | ||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Conventional | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Superficial | ||||||||||||
| Note 1 | ||||||||||||
| Other (specify) | P | Note2(E) |
N= new indication; P= previously cleared by FDA in K011886; E= added under Appendix E
Additional Comments:
| Note1: Specification for "Other": | |
|---|---|
| Gastrointestinal tract, biliary, pancreatic duct and surround organs | |
| Intraluminal ultrasound for upper airways and tracheobronchial tree | |
| Urinary tract | |
| Female reproductive tract: | |
| Note2:3D Imaging |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Logam
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
8
4.3.5 Indications for U se for OLYMPUS GF UM130 Ultrasound Gastrovideoscope
Diagnostic Ultrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | P | Note2(E) | ||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Note1 | ||||||||||
| Other (specify) | P | Note2(E) |
N= new indication; P= previously cleared by FDA in K011886; E= added under Appendix E
Additional Comments:
Note1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Note2:3D Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ... ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Daniel A. Leyson
(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________