SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS
Device Facts
| Record ID | K040502 |
|---|---|
| Device Name | SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IYO · Radiology |
| Decision Date | Mar 9, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
The Ebisu ultrasound imaging system is intended for the following applications: General The Eblog attacoche in Manage of the Scranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superiicial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Device Story
Mobile, software-controlled diagnostic ultrasound system; acquires primary or secondary harmonic ultrasound echo data via various transducers (convex, linear, endocavity, mechanical 3D). Transforms echo data into B-Mode, M-Mode, 3D, or Harmonic Imaging displays on CRT. Operated by clinicians in clinical settings. Provides anatomical measurements and analysis packages for clinical diagnosis. Displays thermal and mechanical indices for bioeffect monitoring. Benefits include non-invasive visualization of internal structures and fluid flow to aid clinical decision-making.
Clinical Evidence
Bench testing only. Compliance with safety and performance standards including UL 2601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-2 (1998), EN 60601-1 series, IEC 1157, and ISO 10993 biocompatibility testing.
Technological Characteristics
Mobile diagnostic ultrasound system; CRT display; supports B-Mode, M-Mode, 3D, and Harmonic Imaging. Transducers include convex, linear, and mechanical 3D arrays. Complies with UL 2601-1, CSA C22.2 No. 601-1, and AIUM/NEMA standards. Biocompatibility per ISO 10993. Software-controlled operation.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, intraoperative, pediatric, small organ, neonatal/adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, laparoscopic, and musculoskeletal applications. Prescription use only.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- SONOLINE G50 & G60 S Diagnostic Ultrasound Systems (K020353)
- SONOLINE Adara Diagnostic Ultrasound System (K946179)
Reference Devices
- GE LOGIQ 500
Submission Summary (Full Text)
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# MAR - 9 2004
# 510(K) SUMMARY
## Ebisu Diagnostic Ultrasound system
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
#### Submitted By: 1.
Siemens Medical Solutions USA, Inc., Ultrasound Division 22010 S.E. 51st Street Issaquah, WA 98029
#### Contact Person:
Patrick J Lynch Regulatory Affairs
Phone: (425) 557-1825 FAX: (425) 391-9198
## Date Prepared:
January 28, 2004
#### 2. Proprietary Name:
Ebisu Ultrasound System
## Common/ Usual Name:
Diagnostic Ultrasound System with Accessories
#### Classification Name:
| 21 CFR 892.1550 | | |
|------------------------------------------|---------------|---------------------|
| Ultrasonic Pulsed Doppler Imaging System | FR # 892.1550 | Product Code 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | FR # 892.1560 | Product Code 90-IYC |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX |
#### 3. Predicate Device:
K020353, 02/13/2002, cleared as Omnia X/XS, marketed as SONOLINE G50 & G60 S Diagnostic Ultrasound Systems
K946179, 10/03/1995, cleared as Prima, and marketed as SONOLINE Adara Diagnostic Ultrasound System
#### 4. Device Description:
The Ebisu is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, a combination of modes, 3D imaging or Harmonic Imaging on a CRT display.
The Ebisu, has been designed to meet the following product safety standards:
- UL 2601-1, Safety Requirements for Medical Equipment
- 에 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic 내 Output Indices on Diagnostic Ultrasound Equipment
- l AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
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- 93/42/EEC Medical Devices Directive 트
- Safety and EMC Requirements for Medical Equipment ■
- . EN 60601-1
- . EN 60601-1-1
- n EN 60601-1-2
- IEC 1157 Declaration of Acoustic Power 重
- ISO 10993 Biocompatibility 트
#### Intended Uses: 5.
Intentious oooo!
The Ebisu ultrasound imaging system is intended for the following applications: General The Eblog attacoche in Manage of the Scranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superiicial Musculoskeletal, and Peripheral Vascular applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
#### Technological Comparison to Predicate Device: ર.
The Ebisu is substantially equivalent to the SONOLINE Adara, cleared via K946179, the The Eblad 16 Subted in any of a K020353, and some features of the GE LOGIQ 500, cleared OONOENE Group Crown transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.
#### End of 510(k) Summary
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 2004
Siemens Medical Solutions USA, Inc. Ultrasound Group % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K040502
Trade Name: SONOLINE Ebisu Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: February 24, 2004 Received: February 27, 2004
## Dear Mr. Job:
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 SONOLINE Ebisu Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
C5-2 Convex Array Transducer L10.5 Linear Array Transducer EV9-4 Convex Array Transducer
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# 7.5L75S Linear Array Transducer EC9-4 Convex Array Endocavity Transducer C4-2 Convex Array Transducer C8-5 Convex Array Transducer BE9-4 Biplane Endocavity Transducer C6F3 Convex Array Mechanically Driven, 3D Transducer EV8F5 Mechanical Sector Endovaginal 3D Transducer 3.5C40S Convex Array Transducer 5.0C40S Convex Array Transducer
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 comply 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
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 predicate device results in a classification for your device and thus permits your device to proceed to market.
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Page 3 - Mr. Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address ''http://www.fda.gov/cdrh/dsmamain.html''.
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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510(k) Number (if known):
SONOLINE Ebisu Diagnostic Ultrasound Systems
Device Name: Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | | | | | | BM | Note 2,3 |
| Abdominal | | P | P | | | | | | BM | Note 2,3 |
| Intraoperative<br>(Note 6) | | P | P | | | | | | BM | Note 3 |
| Intraoperative<br>Neurological | | P | P | | | | | | BM | Note 3 |
| Pediatric | | P | P | | | | | | BM | Note 2,3 |
| Small Organ<br>(Note 1) | | P | P | | | | | | BM | Note 2,3 |
| Neonatal Cephalic | | P | P | | | | | | BM | Note 3 |
| Adult Cephalic | | P | P | | | | | | BM | Note 2 |
| Cardiac | | P | P | | | | | | BM | Note 2 |
| Transesophageal | | P | P | | | | | | BM | Note 2,3 |
| Transrectal | | P | P | | | | | | BM | Note 2,3 |
| Transvaginal | | P | P | | | | | | BM | Note 2,3 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | | | | | | BM | Note 2,3 |
| Laparoscopic | | P | P | | | | | | BM | Note 3 |
| Musculo-skeletal<br>Conventional | | P | P | | | | | | BM | Note 2,3 |
| Musculo-skeletal<br>Superticial | | P | P | | | | | | BM | Note 2,3 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = praviously cleared by FDA with K020353; E = added under Appendix E
For example: breast, testers, thyrold, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
3D imaging Note 3
B&W SleScape panoramic imaging Note 4
Power SieScape panoramic imaging Note ર
For example: abdominal, vascular Note 6
Contrast agent imaging Note 7
> (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)
Nancy C. Brogdon
2
(Division Sign-Division of Reproduct ive. Al and Radiological Devices 510(k) Number
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510(k) Number (if known):
Device Name:
C5-12 Convex Array Transducer for use with: SONOLINE Eblau Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | | | | | | Mode of Operation | | | | |
|----------------------------------|---|---|---|-----|-----|-------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | | | | | | BM | Note 2,3 |
| Abdominal | | P | P | | | | | | BM | Note 2,3 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | | | | | | BM | Note 2,3 |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | | | | | | BM | Note 2,3 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
N = hew indication; P = prevlously claared by FDA with K020353; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic Imaging Note 2
- Note 3 3D Imaging
B&W SieScape panoramic Imaging Note 4
Note 5 Power SieScape panoramic imaging
Note B For example: abdominal, vascular
Note 7 Contrast agent 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)
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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510(k) Number (if known):
Device Name:
# L10.5 Linear Array Transducer for use with: SONOLINE Ebisu Diagnostic Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | | | | | | BM | Note 2,3 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | | | | | | BM | Note 2,3 |
| Small Organ | | P | P | | | | | | BM | Note 2,3 |
| Neonatal Cephalic | | N | N | | | | | | BM | Note 2,3 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | | | | | | BM | Note 2,3 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | | | | | | BM | Note 2.3 |
| Musculo-skeletal<br>Superficial | | P | P | | | | | | BM | Note 2,3 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously claared by FDA with K020353; E = added under Appendix E
For example: breast, testes, thyroid, penls, prostate, etc. Nole 1
- Note 2 Ensemble tissue harmonic Imaging
- Note 3 30 imaging
- B&W SieScape panoramic imaging Nole 4
Note 5 Power SleScape panoramic imaging
For example: abdominal, vascular Note B
Note 7 Contrast agent 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)
Nancy C. Broadon
(Division Sign-Off Division of Reproductive, Ab and Radiological Devices 5 (0(k) Number ---
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510(k) Number (if known):
Device Name:
Intended Use:
EV9-4 Convex Array Transducer for use with: SONOLINE Ebisu Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | | | | | | BM | Note 3 | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Note 1) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | | | | | | BM | Note 3 | |
| Transvaginal | | P | P | | | | | | BM | Note 3 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication: P = previously cleared by FDA with K020353; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- Ensemble tissue harmonic imaging Note 2
- Note 3 3D imaging
- B&W SieScape panoramic imaging Note 4
Power SieScape panoram c imaging Note 5
For example: abdominal, vascular Note 6
Contrast agent Imaging Note 7
> (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)
Nancy C brydon
(Division Sign-Off) Division of Reproductive, Abo and Radiological Devices 510(k) Number
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510(k) Number (it known):
Device Name:
Intended Use:
7,5L175S Linear Array Transducer for use with: SONOLINE Ebisu Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | P | | | | | | | Note 3 | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | | | | | | | Note 3 | |
| Small Organ<br>(Note 1) | | P | P | | | | | | | Note 3 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | | | | | | | Note 3 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | | | | | | | Note 3 | |
| Musculo-skeletal<br>Superficial | | P | P | | | | | | | Note 3 | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA with K946179; E = added under Appandix E
For example: breast, testels, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
30 imaging Note 3
B&W SieScape panoramic Imaging Note 4
Note 5 Power SleScape panoramic Imaging
For example: abdominal, vascular Note 6
Note 7 Contrast agent 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 801.108)
Nancy C. Brogdon
(Division Sign Division of Reproductive, Abdo and Radiological Devices 510(k) Number __
{10}------------------------------------------------
510(k) Number (if known):
EC9-4 Convex Array Endocavily Transducer for use with: Device Name: SONOLINE Ebisu Diagnostic Uitrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | | | | | | BM | Note 3 |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | | | | | | BM | Note 3 |
| Transvaginal | | P | P | | | | | | BM | Note 3 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new Indication: P = previously cleared by FDA with K020353; E = added under Appendix E
For example: breast, testers, thyrold, penis, prostate, elc. Note 1
Ensemble tissue harmonic imaging Note 2
- Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoram c Imaging
For example: abdominal, vascular Note Б
Contrast agent imaging Note 7
> (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)
Nancy C. Beardon
(Division Sig Division of Reproductive, Abdo and Radiological Devices 510(k) Number _
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510(k) Number (II known):
Device Name:
Intended Use:
C4-2 Convex Array Transducer for use with: SONOLINE Ebisu Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
Mode of Operation Color Clinical Application Amplitude Combined Other Calor B M PWD CWD Velocity A (Specify) Doppler Doppler (Specify) Imaging Ophthalmic P P BM Felal Note 2,3 Abdominal P P BM Intraoperative Abdominal Intraoperative Neurological BM P P Pediatric Small Organ (Note 1) Naonatal Cephallo BM Note 2,3 P Adult Cephallc P P P BM Note 2,3 Cardiac Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superlicial Other (specify)
N = new indication; P = previously cleared by FDA with K962142; E = added under Appendix E
For example: breast, testels, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
- Note 3 30 imaging
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
For example: abdominal, vascular Note G
Note 7 Contrast agent 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)
Nancy C. Gordon
(Division Sig Division of Reproductive, Abdo and Radiological Devices 510(k) Number
{12}------------------------------------------------
510(k) Number (il known):
Davice Name:
Intended Use:
C8-5 Convex Array Transducer for use with: SONIOLINE Ebisu Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | | | | | | BM | Note 3 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | | | | | | BM | Note 3 |
| Small Organ<br>(Note 1) | | P | P | | | | | | BM | Note 3 |
| Neonatal Cephalic | | P | P | | | | | | BM | Note 3 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | | | | | | BM | Note 3 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | | | | | | BM | Note 3 |
| Musculo-skeletal<br>Superficial | | P | P | | | | | | BM | Note 3 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA with K020353; E = added under Appendix E
Note t For example: breast, testes, thyrold, penis, prostate, etc.
Ensomble tissue harmonic imaging Nola 2
Note 3 3D imaging
Nole 4 B&W SieScape panoramic imaging
Power SleScape panoramic imaging Note 5
Note B For example: abdominal, vascular
Contrast agent imaging Note 7
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANDTHER PAGE: IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
> > Prescription Use (Per 21 CFR 801.109)
Nancy C bogdon
(Division Sign Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
{13}------------------------------------------------
510(k) Number (if known):
Device Name:
# BE9-4 Biplane Endocavity Transducer for use with: SONOLINE Ebisu Diagnostic Ultrasound Systems
Intended Use:
SONO-LINE Colsu Diagnestic on the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | N | N | | | | | | BM | Note 3 | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ<br>(Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | N | N | | | | | | BM | Note 3 | | |
| Transvaginal | | N | N | | | | | | BM | Note 3 | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
N = new indication; P = prevlously cleared by FDA with K040060; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic Imaging Note 2
- 3D imaging Note 3
- B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
For example: abdominal, vuscular Note B
Contrast agent Imaging Note 7
> (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)
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{14}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
C6F3 Convex Array Mechanically Driven, 3D Transducer for use with: Cor 3 Ourvex Array lagnostic Ultrasound Systems SONOLINE Eblou Diagnostic of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | | | | | | BM | Note 2,3 | |
| Abdominal | | P | P | | | | | | BM | Note 2,3 | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | BM | Note 2,9 | |
| Pediatric | | P | P | | | | | | | | |
| Small Organ<br>(Note 1) | | | | | | | | | | | |
| Neonatal Cephalic | | P | P | | | | | | BM | Note 2,3 | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new Indication; P = previously cleared by FDA with K020353; E = added under Appendix E
For example: breast, testes, thyroid, penls, prostate, etc. Note 1
Ensemble tissus harmonic imaging Note 2
- 3D imaging Note 3
B&W SleScape panoramic imaging Note 4
Power SleScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Contrast agent Imaging Note 7
> (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)
Nancy Brogdon
(Division Sign Division of Reproductive, Abdominal, ana Radiological Devices 510(k) Number ___
{15}------------------------------------------------
510(k) Number (if known):
EV8F5 Mechanical Sector Endovaginal 3D Transducer for use with: Device Name: SONOLINE Ebisu Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows: Intended Use:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | | | | | | BM | Note 3 |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | P | P | | | | | | BM | Note 3 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | | | | | | BM | Note 3 |
| Transvaginal | | P | P | | | | | | BM | Note 3 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = proviously cleared by FDA with K020353; E = added under Appendix E
For example: breast, testes, thyrold, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
- Note 3 3D imaging
.
B&W SieScape panoramic innaging Note 4
Note 5 Power SieScape panoramic imaging
For example; abdominal, vascular Note 8
Note 7 Contrast agent 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)
Manaye Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040502
{16}------------------------------------------------
510(k) Number (if known):
Device Name:
3.5C40S Convex Array Transducer for use with: SONOLINE Ebisu Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | | | | | | BM | Note 2,3 |
| Abdominal | | P | P | | | | | | BM | Note 2,3 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | | | | | | BM | Note 2,3 |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | | | | | | BM | Note 2,3 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA with K946179; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble ilsoue harmonic imaging Note 2
- 30 imaoing Note 3
B&W SieScape panoramic Imaging Note 4
Note 5 Power SleScape panoramic imaging
For example: abdominal, vascular Note B
Note 7 Contrast agent imaging
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDAH, Office of Device Evaluation (ODE)
> > Prescription Use (Per 21 CFR 801.109)
Nancy C Brogdon
(Division Sig Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{17}------------------------------------------------
:::
.
# Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
## 5.0C40S Convex Array Transducer for use with: 5.0C40S Conver Anajanostic Ultrasound Systems
Intended Use:
SONNEINE EBIGG Diagnoeller of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | | | | | | BM | Note 2,3 |
| Abdominal | | P | P | | | | | | BM | Note 2,3 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | | | | | | BM | Note 2,3 |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | BM | Note 2,3 |
| Peripheral vessel | | P | P | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
Other (specify)
N = new indication: P = proviously cleared by FDA with K946179; E = added under Appendix E
For example: breast, testes , thyroid, penis, prostate, atc. Note 1
Ensemble tissua harmonic Imaging Note 2
- 3D imaging Note 3
B&W SleScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Contrast agent Imaging Note 7
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE.ON ANOTHER PAGE IF NEEDED)
> THE CONTINUE CONSULTION Of ODEL Office of Device Evaluation (ODE) Concurrence of CDRH, Office of Device Evaluation (ODE)
> > Prescription Use (Per 21 CFR 801.109)
Nancy C Brogdon
Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 5 10(k) Number ...............................................................................................................................................................
November 24, 2003
14
