SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
Device Facts
| Record ID | K042833 |
|---|---|
| Device Name | SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IYO · Radiology |
| Decision Date | Oct 27, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
The G20 ultrasound imaging system is intended for the following applications: General Radiology, Cardiac, Pelvic, Neonatal/Adult Cephalic, Abdominal, Small Parts, Transcranial, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis 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. Transforms echo data into B-Mode, M-Mode, 3D imaging, or Harmonic Imaging; displays on CRT. Used in clinical settings by physicians/technicians for anatomical measurement and fluid flow analysis. Output assists in clinical diagnosis and decision-making; provides thermal and mechanical indices for bioeffect monitoring. Benefits include non-invasive visualization of internal structures and blood flow.
Clinical Evidence
Bench testing only. The device complies with UL 60601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-2 (1998) for acoustic output, and EMC requirements. No clinical data presented.
Technological Characteristics
Mobile diagnostic ultrasound system; CRT display. Supports multiple transducer types (convex, linear, mechanical sector, biplane). Energy source: ultrasonic pulsed echo/Doppler. Connectivity: on-screen display for thermal/mechanical indices. Software-controlled. Biocompatibility per ISO 10993. Safety standards: UL 60601-1, CSA C22.2 No. 601-1, IEC 1157.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in general radiology, cardiac, pelvic, neonatal/adult cephalic, abdominal, small parts, transcranial, superficial musculoskeletal, and peripheral vascular applications. Patient population includes neonates, pediatric, and adult patients. Contraindications not specified.
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 G20 Diagnostic Ultrasound System (K040502)
- SONOLINE G50 & G60 S Diagnostic Ultrasound Systems (K020353)
- SONOLINE Adara Diagnostic Ultrasound System (K946179)
Submission Summary (Full Text)
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# OCT 2 7 2004
## 510(K) SUMMARY
## G20 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.
#### 1. Submitted By:
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:
September 20, 2004
#### 2. Proprietary Name:
SONOLINE G20™ Diagnostic 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-IYO |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX |
#### 3. Predicate Device:
K040502, 03/09/2004, SONOLINE G20 Diagnostic Ultrasound System K020353, 02/13/2002, SONOLINE G50 & G60 S Diagnostic Ultrasound Systems K946179, 10/03/1995, marketed as SONOLINE Adara Diagnostic Ultrasound System
#### Device Description: 4.
The G20 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 G20, has been designed to meet the following product safety standards:
- 트 UL 60601-1, Safety Requirements for Medical Equipment
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- 마 AIUM/NEMA, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 트 AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 프 93/42/EEC Medical Devices Directive
- 마 Safety and EMC Requirements for Medical Equipment
{1}------------------------------------------------
- l EN 60601-1
- EN 60601-1-1 b
- EN 60601-1-2
- EN 60601-2-37 피
- IEC 1157 Declaration of Acoustic Power .
- ISO 10993 Biocompatibility I
#### Intended Uses: ട.
Intended Uses.
The G20 ultrasound imaging system is intended for the following applications: General Radiology, The G20 ultrasound imaging oyoten is more of the Cardiac, Pelvic, Neonatal/Adult Cephalic, Abdoninal, Sinali Paris, Transonana, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides for the measurement of anatomical structures and for analysis The system also provide ior the n the n that is used for clinical diagnosis purposes.
#### Technological Comparison to Predicate Device: 6.
The G20 is substantially equivalent to the SONOLINE Adara, cleared via K946179, the The G20 is substantially equivality of the SONOLINE G20, cleared via K040502. All SONOLINE ലോഗ Ooo Or dicared into patients, then perform post processing of received systems transmit ultrasonic chorgy into panatomic structures and fluid flow within the body. All echoes to generate on occoon alopiar of antitres and flow, and calculations.
### End of 510(k) Summary
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is an abstract image of an eagle.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 27 2004
Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K042833
Trade Name: SONOLINE G20™ 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: October 11, 2004 Received: October 13, 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 G20™ Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
C5-2 Convex Array L10-5 Linear Array EV9-4 Convex Array 7.5L75S Linear Array
{3}------------------------------------------------
## EC9-4 Convex Array Endocavity C4-2 Convex Array C8-5 Convex Array BE9-4 Biplane Endocavity C6F3 Convex Array Mechanically Driven, 3D EV8F5 Mechanical Sector Endovaginal 3D 3.5C40S Convex Array 5.0C40S Convex Array Endo PII Mechanical Sector Biplane Endo-cavity Endo VII Mechanical Sector Endovaginal
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,
David A. Ayres
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 G20™ 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>Superficial | | P | P | | | | | | BM | Note 2,3 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA with K040502; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 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)
David A. Lynn
(Division Sign 510k
{6}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
C5-2 Convex Array Transducer for use with: SONOLINE G20™ 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 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 = new indication; P = previously cleared by FDA with K040502; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 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)
Daniel A. Lyman
Division Sign-O of Reproductive. Abdor 510k)
{7}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
#### L 10-5 Linear Array Transducer for use with: SONOLINE G20™ Diagnostic Ultrasound Systems Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation Color Clinical Application Combined Other Amplitude Color CWD Velocity B M PWD A Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal BM Note 2,3 P P Abdominal Intraoperative Abdominal Intraoperative Neurological Note 2,3 BM p P Pediatric BM Note 2,3 P P Small Organ BM Note 2,3 N N Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal Transvaginal Transurethral Intravascular BM P P Note 2,3 Peripheral vessel Laparoscopic Musculo-skeletal P P BM Note 2,3 Conventional Musculo-skeletal P P BM Note 2,3 Superficial Other (specify)
N = new indication; P = previously cleared by FDA with K040502; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
3D imaqing Note 3
Note 4 B&W SieScape panoramic imaging
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) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Num
{8}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
EV9-4 Convex Array Transducer for use with: SONOLINE G20™ 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 K040502; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaqing
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
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)
David A. Dymm
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042833
{9}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
7.5L75S Linear Array Transducer for use with: SONOLINE G20™ 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 K040502; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
3D imaging Note 3
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
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)
David h. hyson
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{10}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
EC9-4 Convex Array Endocavity Transducer for use with: SONOLINE G20™ 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 K040502; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 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)
David A. haysen
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
{11}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
C4-2 Convex Array Transducer for use with: SONOLINE G20™ 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 | |
| Abdominal | | P | P | | | | | | BM | Note 2,3 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | | | | | | BM | |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | P | P | | | | | | BM | Note 2,3 |
| Cardiac | | P | P | | | | | | BM | Note 2,3 |
| 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 K040502; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 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)
David A. Lynn
(Division Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number -
{12}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
C8-5 Convex Array Transducer for use with: SONOLINE G20™ 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 K040502; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 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)
David A. Lynn
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number
{13}------------------------------------------------
510(k) Number (if known):
Device Name:
BE9-4 Biplane Endocavity Transducer for use with: SONOLINE G20™ Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
Intended Use:
Mode of Operation Color Clinical Application Color Amplitude Combined Other B CWD PWD A M Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic N N BM Note 3 Fetal Abdominal Intraoperative Abdominal Intraoperative Neurological Pediatric Small Organ (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 Conventional Musculo-skeletal Superficial Other (specify)
N = new indication; P = previously cleared by FDA with K040502; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaqing
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 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)
David R. Lyon
(Division Sign-Off) Division of Reproductive, Abdomina 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: SONOLINE G20™ 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 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 | | 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 K040502; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaginq
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape 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)
David A. Layne
(Division Sign-Off Division of Reproductive. Abdom and Radiological Devices 510(k) Number
{15}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
EV8F5 Mechanical Sector Endovaginal 3D Transducer for use with: SONOLINE G20™ 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 | | 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 = previously cleared by FDA with K040502; 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
Note 4 B&W SieScape panoramic imaging
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) Concurrence of CDRH, Office of Device Evaluation (ODE)
Dan M. Hageman
(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number
{16}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
#### 3.5C40S Convex Array Transducer for use with: SONOLINE G20™ 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 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 K040502; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 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)
David A. Kynn
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number __
{17}------------------------------------------------
510(k) Number (if known):
Device Name:
## 5.0C40S Convex Array Transducer for use with: SONOLINE G20™ 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 K040502; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaqinq
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
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)
David A. heppner
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{18}------------------------------------------------
510(k) Number (if known):
Device Name:
## Endo PII Mechanical Sector Biplane Endo-cavity Transducer for use with: SONOLINE G20™ Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis 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 | | N | N | | | | | | BM | Note 2,3 |
| Abdominal | | N | N | | | | | | BM | Note 2,3 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | N | | | | | | BM | Note 2,3 |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | N | N | | | | | | BM | Note 2,3 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
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)
David A. Hanson
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number
{19}------------------------------------------------
510(k) Number (if known):
Device Name:
## Endo VII Mechanical Sector Endovaginal Transducer for use with: SONOLINE G20™ 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 | | N | N | | | | | | BM | Note 2,3 |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | N | N | | | | | | BM | Note 2,3 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | N | N | | | | | | BM | Note 2,3 |
| Transvaginal | | N | N | | | | | | BM | Note 2,3 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | |…
