SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS

K071314 · Siemens Medical Solutions USA, Inc. · IYO · May 22, 2007 · Radiology

Device Facts

Record IDK071314
Device NameSONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
ApplicantSiemens Medical Solutions USA, Inc.
Product CodeIYO · Radiology
Decision DateMay 22, 2007
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1560
Device ClassClass 2
AttributesPediatric, 3rd-Party Reviewed

Intended Use

The G20 ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial 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; displays in B-Mode, M-Mode, 3D, or Harmonic Imaging on CRT. Used in clinical settings by healthcare professionals for anatomical measurement and analysis. Transmits ultrasonic energy into patients; performs post-processing of received echoes to generate on-screen display of structures and fluid flow. Output assists clinicians in diagnosis; potential patient benefit through non-invasive visualization of internal structures.

Clinical Evidence

Bench testing only. No clinical data provided. Device complies with UL 60601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, and ISO 10993 biocompatibility standards.

Technological Characteristics

Mobile diagnostic ultrasound system; CRT display; supports multiple transducer types (convex, linear, mechanical sector). Energy source: ultrasonic pulsed echo/Doppler. Connectivity: standard ultrasound interface. Software-controlled. Biocompatibility per ISO 10993. Safety standards: UL 60601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-2/UD-3.

Indications for Use

Indicated for diagnostic imaging or fluid flow analysis of the human body in fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K071314 G20 Diagnostic Ultrasound System 510(k) Submission # 510(K) SUMMARY # MAY 2 2 2007 ### 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 1230 Shorebird Way Mountain View, CA 94043 ### Contact Person: Martina Vogt Regulatory Affairs Phone: (425) 557-1434 FAX: (425) 391-9198 #### Date Prepared: May 2, 2007 #### 2. Proprietary Name: SONOLINE G20™ Diagnostic Ultrasound System ### Common/ Usual Name: Diagnostic Ultrasound System with Accessories #### Classification Name: CED 000 4000 | 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: K042833, 10/27/2004, SONOLINE G20 Diagnostic Ultrasound System 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 #### 4. Device Description: 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. lts 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 - 트 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment - 트 AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment - 트 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound - I 93/42/EEC Medical Devices Directive {1}------------------------------------------------ - Safety and EMC Requirements for Medical Equipment - I EN 60601-1 - 트 EN 60601-1-1 - I EN 60601-1-2 - I EN 60601-2-37 - 월 IEC 61157 Declaration of Acoustic Power - 이 ISO 10993 Biocompatibility #### 5. Intended Uses: The G20 ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial 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. #### 6. Technological Comparison to Predicate Device: The G20 is substantially equivalent to the SONOLINE Adara, cleared via K946179, the SONOLINE G50/G60 S, cleared via K020353, the SONOLINE G20, cleared via K040502 and the SONOLINE G20, cleared via K042833. All systems 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 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles a human figure embracing a bird, which is a common representation of health and human services. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Siemens Medical Solutions USA, Inc. Ultrasound Division % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313 MAY 2 2 2007 Re: K071314 Trade Name: SONOLINE G20™ Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging 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: IYN, IYO, and ITX Dated: May 9, 2007 Received: May 10, 2007 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 Systems, as described in your premarket notification: {3}------------------------------------------------ #### Transducer Model Number C5-2 Convex Array L10-5 Linear Array EV9-4 Convex Array 7.5L75S Linear Array EC9-4 Convex Array C4-2 Convex Array C8-5 Convex Array BE9-4 Biplane Endocavity C6-F3 Convex Array Mechanically Driven 3D EV8F5 Mechanical Sector Endocavity 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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: {4}------------------------------------------------ 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. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666. Sincerely yours, 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) {5}------------------------------------------------ | 510(k) Number (if known): | K071314 | Page 1 of 1 | |---------------------------|--------------------------------------------|-------------| | Device Name: | SONOLINE G20™ Diagnostic Ultrasound System | | | Indications for Use: | | | The G20™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial 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. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use<br>(Per 21 CFR 801.109) | ✓ | OR | Over-the-Counter-Use<br>(Optional Format 1-2-96) | |------------------------------------------|---|----|--------------------------------------------------| |------------------------------------------|---|----|--------------------------------------------------| > ante (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 1 : : . . {6}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: # 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>(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 K042833; 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) Nancyc Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number 1207/3/4 {7}------------------------------------------------ 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 K04283; 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) > > Prescription Use (Per 21 CFR 801.109) Nancy C Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number 2071314 {8}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: #### L10-5 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 Clinical Application Color Color Amplitude Combined Other A B M PWD CWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal Abdominal P P Note 2,3 BM Intraoperative Abdominal Intraoperative Neurological Pediatric P b BM Note 2,3 Small Organ P P BM Note 2,3 P Neonatal Cephalic P BM Note 2,3 Adult Cephalic Cardiac Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P P BM Note 2,3 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 K042833; 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 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 801.109) Nancy bragdon (Division Sign-O Division of Reproduct and Radiological Devices 510(k) Number {9}------------------------------------------------ 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: | 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 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 K042833; 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 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 801.109) Nancy C Broadon (Division Sign-Off) Division of Reproductive, Abdor and Radiological Devices 510(k) Number_ {10}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: 7.5L75S Linear Array Transducer for use with: SONOLINE G20™ Diagnostic Uitrasound 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 K042833; 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 B&W SieScape panoramic imaging Note 4 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) > > Prescription Use (Per 21 CFR 801.109) Nancy Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K071314 {11}------------------------------------------------ 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 K042833; 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) Nancy C. Brogdon (Division Sign-Off) Division of Reproduc and Radiological Devices 510(k) Number ___ {12}------------------------------------------------ 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 K04283; 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 - B&W SieScape panoramic imaging Note 4 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) > > Prescription Use (Per 21 CFR 801.109) Nancy C. Brogdon (Division Sign-O Division of Reproductive, Abdor and Radiological Devic 510(k) Number _ {13}------------------------------------------------ 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 K042833; 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 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) Nancy Broadon Division Sign-Off (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices ு ப்ருடு Number _____________________________________________________________________________________________________________________________________________________________ {14}------------------------------------------------ 510(k) Number (if known): Device Name: # BE9-4 Biplane Endocavity 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 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 K042833; 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) > > Prescription Use (Per 21 CFR 801.109) Nancy C. Snowdon (Division Sign-Division of Reproductive, Atic and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ {15}------------------------------------------------ 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 K04283; 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 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) > > Prescription Use (Per 21 CFR 801.109) Nancy C. Brogdon (Division Sign-Off) Division of Reproductive Ahdor and Radiological Devices 510(k) Number _ {16}------------------------------------------------ 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 K042833; 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) Nancy Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K0713/4 {17}------------------------------------------------ 510(k) Number (if known): Device Name: 3.5C40S 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 K04283; 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 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) Nancy Brogdon (Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number _ {18}------------------------------------------------ 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 K04283; 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 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) Nancy C Brogdon (Division Sign-Off) Division of Reproduct tive, Abdon and Radiological Devices 510(k) Number __ {19}------------------------------------------------ 510(k) Number (if known): Device Name: Endo PIt 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: | | 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 | | | | | | | | | | | | Intraoperative<br>Abdominal | | | | | | | | | | | | Intraoperative<br>Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ<br>(Note 1) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | |…
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