SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM

K981528 · Siemens Medical Solutions USA, Inc. · IYO · Oct 28, 1998 · Radiology

Device Facts

• Record ID: K981528
• Device Name: SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYO · Radiology
• Decision Date: Oct 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SONOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications. The addition of contrast agent imaging will not add any new applications or intended uses. 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

The SONOLINE Elegra is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers and displays images in B-Mode, M-Mode, Color Mode, Pulsed (PW) Doppler, and Continuous (CW) Doppler. The system includes a patented Contrast Agent Imaging (CAI) technique (US patent 5,632,277) and harmonic imaging capabilities. It processes signals to enhance imaging of tissues and structures reflecting ultrasound at harmonic frequencies. The system provides on-screen thermal and mechanical indices for bioeffect monitoring. It is operated by clinicians in various clinical settings to perform anatomical measurements and analysis for diagnostic purposes. The output is displayed on a CRT, assisting clinicians in clinical decision-making across multiple specialties.

Clinical Evidence

Bench testing only. The submission relies on technical performance data and compliance with safety standards for diagnostic ultrasound equipment, including acoustic output measurements and adherence to AIUM/NEMA standards for thermal and mechanical indices.

Technological Characteristics

Mobile diagnostic ultrasound system; supports B-mode, M-mode, PW/CW Doppler, Color/Amplitude Doppler, and harmonic imaging. Transducers include phased, curved, and linear arrays. Connectivity includes on-screen display of thermal/mechanical indices. Complies with UL 2601-1, CSA 22.2 No. 601-1, and IEC 60601-1/1-2 safety/EMC standards. Software-controlled operation.

Indications for Use

Indicated for general radiology, abdominal, intraoperative, small parts, transcranial, OB/GYN, pelvic, neonatal/adult cephalic, urology, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Contraindicated for in vitro fertilization and percutaneous umbilical blood sampling.

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

• Acuson Sequoia Ultrasound System and Harmonic Imaging with Contrast Option (K973767)
• SONOLINE Elegra (K945072)

Submission Summary (Full Text)

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#### OCT 28 1998 510(K) SUMMARY

K9815528

# Addition of Contrast Agent Imaging to SONOLINE Elegra 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. Contrast Agent Imaging (CAI) is a patented technique (US patent number 5,632,277).

#### Submitted Bv: 1.

Siemens Medical Systems. Inc., Ultrasound Group 22010 S.E. 51st Street Issaquah, WA 98027-7002

# Contact Person:

Steve Hesler Manager of Regulatory Affairs [phone]

# Date Prepared:

March 31, 1998

#### 2. Proprietary Name:

SONOLINE Elegra Advanced SONOLINE Elegra

# Common/ Usual Name:

Diagnostic Ultrasound System with Accessories

# Classification Name:

| 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:

- . Acuson Sequoia™ Ultrasound System and Harmonic Imaging with Contrast Option (K973767, 12/23/97)
- . SONOLINE Elegra (K945072, 11/21/95).

#### 4. Device Description:

The SONOLINE Elegra 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 ultrasound data and display it in B-Mode, M-Mode, Color Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.

The SONOLINE ® Eleara, has been designed to meet the following product safety standards:

- UL 2601-1. Safety Requirements for Medical Equipment
- CSA 22.2 No. 601-1, Safety Requirements for Medical Equipment
- Standard for Real Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound Equipment, AIUM/NEMA, 1992.

{1}------------------------------------------------

.

- 93/42/EEC Medical Devices Directive EN60601 = (IEC 601-1+ IEC 601-1-2). Safety and EMC Requirements for Medical Equipment
#### 5. Intended Uses:

The SQNOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications. The addition of contrast agent imaging will not add any new applications or intended uses.

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:

Both the SONOLINE Elegra and the predicate device from Acuson are full-featured, highend diagnostic ultrasound systems capable of B-mode, M-mode, CW Doppler, Color Doppler. Amplitude Doppler, and combined imaging modes utilizing a number of transducers with varying center frequencies.

Both systems are modified to optimize images obtained with the use of diagnostic ultrasound and ultrasound contrast agents.

Both systems employ modified transmit/receive functions which allow for enhanced imaging of tissues and structures which reflect the transmitted ultrasound at a harmonic, or multiple, of the transmit frequency.

# End of 510(k) Summary

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing the wings and body. The eagle is facing to the right.

OCT 28 1998

Steve Hesler Manager of Regulatory Affairs Siemens Medical Systems, Inc. Ultrasound Group

22010 S.E. 51st St. Issaquah, WA 98029-7002

Re: K981528 Trade Name: Sonoline Elegra and Elegra Advanced Diagnostic Ultrasound System (with Harmonic Imaging) Regulatory Class: II Product Code: 90 IYO/21 CFR 892.1560 Dated: October 7, 1998 Received: October 9, 1998

Dear Mr. Hesler:

We have reviewed your Section 510(k) 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 probes intended for use with the Sonoline Elegra and Elegra Advanced Diagnostic Ultrasound System, as described in your premarket notification:

Probes Model Number

2.5PL20 Phased Array 3.5PL28 Phased Array 3.5C40 Curved Array 5.0HDPL40 Linear Array 5.0C50 Curved Array 6.5EC10 Curved Array 6.5EV13 Curved Array 7.5C30 Curved Array 7.5L40 Linear Array 7.5PL13 Phased Array

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Steve Hesler

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone] 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 594-1212,

Sincerely yours,

Gerald li. Segman

Lillian Yin, Ph.D. Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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# Attachment 1

Ultrasound Device Indications Statement

510 (k) Number (if known) : Device Name : Intended Use:

K981528 SONOLINE Elegra/Elegra Advanced See below

Mode of Operation

| Mode of Operation | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging |
|-------------------|----------------------------------|---|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|------------------|
| | Ophthalmic | | | | | | | | | | |
| | Fetal | P | P | P | P | P | P | P | | BMDC (P) | N |
| | Abdominal | P | P | P | P | P | P | P | | BMDC (P) | N |
| | Intraoperative<br>(Specify) * | P | P | P | P | P | P | P | | BMDC (P) | |
| | Pediatric | P | P | P | P | P | P | P | | BMDC (P) | N |
| | Small Organ<br>(Specify) ** | P | P | P | P | P | P | P | | BMDC (P) | N |
| | Neonatal<br>Cephalic | P | P | P | P | P | P | P | | BMDC (P) | |
| | Adult Cephalic | P | P | P | P | P | P | P | | BMDC (P) | |
| | Cardiac | P | P | P | P | P | P | P | | BMDC (P) | N |
| | Trans-esophageal | | | | | | | | | | |
| | Transrectal | P | P | P | P | P | P | P | | BMDC (P) | |
| | Transvaginal | P | P | P | P | P | P | P | | BMDC (P) | N |
| | Transurethral | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| | Peripheral<br>vessel | P | P | P | P | P | P | P | | BMDC (P) | N |
| | Laparoscopic | | | | | | | | | | |
| | Musculo-skeletal<br>Conventional | P | P | P | P | P | P | P | | BMDC (P) | N |
| | Musculo-skeletal<br>Superficial | P | P | P | P | P | P | P | | BMDC (P) | N |
| | Other (specify) | | | | | | | | | | |

E = added under Appendix E N = new indication; P = previously cleared by FDA;

Additional Comments:

* = intraoperative (abdominal, neurological)

** = small organs (breast,testes, thryoid, penis,prostate)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Sypem

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi

510(k) Number K981528

{5}------------------------------------------------

510 (k) Number (if known) :

Device Name :

K981528 2.0 CW probe for use with SONOLINE Elegra/Elegra Advanced

Intended Use:

| Device Name: | | 2.5 CW probe for use with Sonoline Glegra & Glegra Advanced | | | | | | | | |
|----------------------------------|---|-------------------------------------------------------------|---|-----|-----|--------------------------------|----------------------|------------------------------|----------------------------|---------------------|
| Intended Use: | | See below | | | | | | | | |
| Mode of Operation | | | | | | | | | | |
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | P | | | | | | |
| Abdominal | | | | P | | | | | | |
| Intraoperative<br>(Specify) | | | | P | | | | | | |
| Pediatric | | | | P | | | | | | |
| Small Organ<br>(Specify) | | | | P | | | | | | |
| Neonatal | | | | P | | | | | | |
| Cephalic | | | | P | | | | | | |
| Adult Cephalic | | | | P | | | | | | |
| Cardiac | | | | P | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Transrectal | | | | P | | | | | | |
| Transvaginal | | | | P | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>vessel | | | | P | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | P | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| N = new indication; | | | | | | P = previously cleared by FDA; | | | E = added under Appendix E | |
| Additional Comments: | | | | | | | | | | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David b. Segner

(Divisio Sign-Off Division of Reproductive, Abdominal, ENT and Radiological Devi

510(k) Number

{6}------------------------------------------------

## 510 (k) Number (if known) :

K981528

| Device Name: 25PL20 Phased Array Transducer for use with SONOLINE Elegra/Elegra Advanced | | | | | | | | | | |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Intended Use: See below. | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | |
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | E | E | E | E | E | E | E | | BMDC (E) | N |
| Abdominal | E | E | E | E | E | E | E | | BMDC (E) | N |
| Intraoperative<br>(Specify) | | | | | | | | | | |
| Pediatric | E | E | E | E | E | E | E | | BMDC (E) | N |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal | E | E | E | E | E | E | E | | BMDC (E) | |
| Cephalic<br>Adult | E | E | E | E | E | E | E | | BMDC (E) | |
| Cephalic<br>Cardiac | E | E | E | E | E | E | E | | BMDC (E) | N |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | N |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>vessel | E | E | E | E | E | E | E | | BMDC (E) | N |
| Laparoscopic | | | | | | | | | | |
| Musculo-<br>skeletal | | | | | | | | | | |
| Conventional<br>Musculo-<br>skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other<br>(Specify) | | | | | | | | | | |
| | N = new indication; Additional Comments:<br>P = previously cleared by FDA; E = added under Appendix E | | | | | | | | | |

2.5PL20 Phased Array Transducer for use with SONOLINE Elegra/Elegra Advanced Device Name : See helow

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Jamil le. Sezmm

(Divis on Sign-Off) Reproductive, Abdominal, El Divisio and Radiological De

510(k) Number K981528

{7}------------------------------------------------

| Device Name: 3.5PL28 Phased Array Transducer for use with SONOLINE Elegra/Elegra Advanced<br>Intended Use: See below. | | | | | | | | | | |
|-----------------------------------------------------------------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Mode of Operation | | | | | | | | | | |
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | BMDC (P) | N |
| Abdominal | P | P | P | P | P | P | P | | BMDC (P) | N |
| Intraoperative<br>(Specify) | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | BMDC (P) | N |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | P | P | P | P | P | P | P | | BMDC (P) | |
| Adult Cephalic | P | P | P | P | P | P | P | | BMDC (P) | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>vessel | P | P | P | P | P | P | P | | BMDC (P) | N |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| N = new indication; P = previously cleared by FDA; E = added under Appendix E | | | | | | | | | | |

510 (k) Number (if known) : K981528

Device Name :

3.5PL28 Phased Array Transducer for use with SONOLINE Elegra/Elegra Advanced

Trans-
esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral
vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (Specify)

| P | P | P | P | P | P | BMDC (P) | N |
|---|---|---|---|---|---|----------|---|
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David li. Leymm

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number

{8}------------------------------------------------

510 (k) Number (if known) : K981528

Device Name :

Intended Use:

3.5C40 Curved Array Transducer for use with SONOLINE Elegra/Elegra Advanced See below

| Mode of Operation | | | | | | | | | | |
|---------------------------------------------|---|---|---|-----|-----|--------------------------------|----------------------|------------------------------|----------------------------|---------------------|
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | E | E | E | | E | E | | BMDC (E) | N |
| Abdominal | | E | E | E | | E | E | | BMDC (E) | N |
| Intraoperative<br>(Specify) | | | | | | | | | | |
| Pediatric | | E | E | E | | E | E | | BMDC (E) | N |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>vessel | | E | E | E | | E | E | | BMDC (E) | N |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | E | E | E | | E | E | | BMDC (E) | N |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| N = new indication;<br>Additional Comments: | | | | | | P = previously cleared by FDA; | | | E = added under Appendix E | |

ﻪ: ﺑ

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymann

Sign-Off Reproductive, Abdominal, EN and Ra

Radiological Devices
510(k) Number K981528

{9}------------------------------------------------

| Ultrasound Device Indications Statement | | | | | | | | | | |
|-----------------------------------------|-----------------------------------------------------------------------|---|---|-----|-----|---------------|----------------------------|------------------------|--------------------|------------------|
| 510 (k) Number (if known) : | K981528 | | | | | | | | | |
| Device Name : | 5.0HDPL40 Linear Array Transducer for use with SONOLINE Elegra/Elegra | | | | | | | | | |
| | Advanced | | | | | | | | | |
| Intended Use: | See below | | | | | | | | | |
| Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC (P) | N |
| Abdominal | | P | P | P | | P | P | | BMDC (P) | N |
| Intraoperative (Specify) | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC (P) | N |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC (P) | N |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | P | P | P | | P | P | | BMDC (P) | N |
| Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| N = new indication; | P = previously cleared by FDA; | | | | | | E = added under Appendix E | | | |
| Additional Comments: | | | | | | | | | | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Elnil A. Syverson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number

{10}------------------------------------------------

K981528

Device Name :

5.0C50 Curved Array Transducer for use with SONOLINE Elegra Elegra Advanced See below

| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
|-----------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC (P) | N |
| Abdominal | | P | P | P | | P | P | | BMDC (P) | N |
| Intraoperative<br>(Specify) | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC (P) | N |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>vessel | | P | P | P | | P | P | | BMDC (P) | N |
| Laparoscopic | | | | | | | | | | |
| Musculo-<br>skeletal | | P | P | P | | P | P | | BMDC (P) | N |
| Conventional | | | | | | | | | | |
| Musculo-<br>skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number

510 (k) Number (if known) : Device Name : Intended Use:

{11}------------------------------------------------

#### 510 (k) Number (if known) : K981528

Device Name : Intended Use: 6.5EC10 Curved Array Transducer for use with SONOLINE Elegra/Elegra Advanced See below

Mode of Operation

| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
|--------------------------------------|---|---|---|-----|-----|--------------------------------|----------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(Specify) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) ** | | E | E | E | | E | E | | BMDC (E) | N |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Transrectal | | E | E | E | | E | E | | BMDC (E) | |
| Transvaginal | | E | E | E | | E | E | | BMDC (E) | N |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-<br>skeletal | | | | | | | | | | |
| Conventional<br>Musculo-<br>skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| N = new indication; | | | | | | P = previously cleared by FDA; | | E = added under Appendix E | | |
| Additional Comments: | | | | | | | | | | |

** =small organ (breast, testes, thyroid, penis, prostate)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Syverson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological 510(k) Number

{12}------------------------------------------------

## K981528

510 (k) Number (if known) : Device Name :

6.5EV13 Curved Array Transducer for use with SONOLINE Elegra/Elegra Advanced Intended Use: See below

| Mode of Operation | | | | | | | | | | | |
|------------------------------------------------------------|---|---|---|-----|-----|--------------------------------|----------------------|------------------------------|----------------------------|---------------------|--|
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(Specify) | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) ** | | P | P | P | | P | P | | BMDC (P) | N | |
| Neonatal | | P | P | P | | P | P | | BMDC (P) | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans- esophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC (P) | | |
| Transvaginal | | P | P | P | | P | P | | BMDC (P) | N | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral<br>vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-<br>skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-<br>skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
| N = new indication; | | | | | | P = previously cleared by FDA; | | | E = added under Appendix E | | |
| Additional Comments: | | | | | | | | | | | |
| ** =small organ (breast, testes, thyroid, penis, prostate) | | | | | | | | | | | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Elmer A. Leyson

(Division Sign-Off) Division of Repreductive, Abdominal, ENT and Radiological De

510(k) Number K981528

{13}------------------------------------------------

## 510 (k) Number (if known) :

Device Name : Intended Use: K981528 7.5C30 Curved Array Transducer for use with SONOLINE Elegra Elegra Advanced See below

of Operatio

| Mode of Operation | | | | | | | | | | |
|--------------------------------------|---|---|---|-----|-----|--------------------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | E | E | E | | E | E | | BMDC (E) | N |
| Abdominal | | E | E | E | | E | E | | BMDC (E) | N |
| Intraoperative<br>(Specify) | | | | | | | | | | |
| Pediatric | | E | E | E | | E | E | | BMDC (E) | N |
| Small Organ<br>(Specify) ** | | E | E | E | | E | E | | BMDC (E) | N |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>vessel | | E | E | E | | E | E | | BMDC (E) | N |
| Laparoscopic | | | | | | | | | | |
| Musculo-<br>skeletal | | E | E | E | | E | E | | BMDC (E) | N |
| Conventional<br>Musculo-<br>skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other<br>(Specify) | | | | | | | | | | |
| N = new indication; | | | | | | P = previously cleared by FDA; | | E = added under Appendix E | | |

Additional Comments:

** =small organ (breast, testes, thyroid, penis)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lynam

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiologic

510(k) Number K981528

{14}------------------------------------------------

#### 510 (k) Number (if known) : K981528

Device Name :

7.5L40 Linear Array Transducer for use with SONOLINE Elegra/Elegra Advanced See below

Intended Use: Ande of Operation

| Mode of Operation | | | | | | | | | | |
|-------------------------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC (P) | N |
| Abdominal | | P | P | P | | P | P | | BMDC (P) | N |
| Intraoperative<br>(Specify) * | | P | P | P | | P | P | | BMDC (P) | |
| Pediatric | | P | P | P | | P | P | | BMDC (P) | N |
| Small Organ<br>(Specify) ** | | P | P | P | | P | P | | BMDC (P) | N |
| Neonatal | | P | P | P | | P | P | | BMDC (P) | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>vessel | | P | P | P | | P | P | | BMDC (P) | N |
| Laparoscopic | | | | | | | | | | |
| Musculo-<br>skeletal<br>Conventional | | P | P | P | | P | P | | BMDC (P) | N |
| Musculo-<br>skeletal<br>Superficial | | P | P | P | | P | P | | BMDC (P) | N |
| Other (Specify) | | | | | | | | | | |
| N = new indication; P = previously cleared by FDA; E = added under Appendix E | | | | | | | | | | |

Additional Comments:

* = intraoper…