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K Number
K981528
Device Name
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC.
Date Cleared
1998-10-28

(182 days)

Product Code
IYO
Regulation Number
892.1560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
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.
More Information

K973767, K945072

Not Found

No
The document describes a standard ultrasound system with various imaging modes and measurement capabilities, with no mention of AI or ML technologies in the device description, intended use, or other sections.

No
The device is described as a "diagnostic ultrasound system" intended for "clinical diagnosis purposes" and for "imaging." It does not mention any therapeutic functions or applications.

Yes
The device description explicitly states, "The SONOLINE Elegra is a general purpose, mobile, software-controlled, diagnostic ultrasound system." Additionally, the intended use/indications for use mentions, "The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes."

No

The device description explicitly states it is a "diagnostic ultrasound system" and describes hardware components like a CRT display and the ability to acquire ultrasound data, indicating it is not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Description: The SONOLINE Elegra is described as a diagnostic ultrasound system. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
  • Intended Use: The intended uses listed are all related to imaging various anatomical sites within the body. While the system provides measurements and analysis for clinical diagnosis, this is based on the ultrasound images, not on the analysis of biological samples.

Therefore, the SONOLINE Elegra is a diagnostic imaging device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for 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.

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

Clinical Application for SONOLINE Elegra/Elegra Advanced:
Fetal, Abdominal, Intraoperative (abdominal, neurological), Pediatric, Small Organ (breast, testes, thyroid, penis, prostate), Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

Clinical Application for 2.0 CW probe:
Fetal, Abdominal, Intraoperative, Pediatric, Small Organ, Neonatal, Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral vessel, Musculo-skeletal Conventional.

Clinical Application for 2.5PL20 Phased Array Transducer:
Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral vessel, Musculo-skeletal Conventional.

Clinical Application for 3.5PL28 Phased Array Transducer:
Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Peripheral vessel.

Clinical Application for 3.5C40 Curved Array Transducer:
Fetal, Abdominal, Pediatric, Peripheral vessel, Musculo-skeletal Conventional.

Clinical Application for 5.0HDPL40 Linear Array Transducer:
Fetal, Abdominal, Pediatric, Peripheral vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

Clinical Application for 5.0C50 Curved Array Transducer:
Fetal, Abdominal, Pediatric, Peripheral vessel, Musculo-skeletal Conventional.

Clinical Application for 6.5EC10 Curved Array Transducer:
Small Organ (breast, testes, thyroid, penis, prostate), Transrectal, Transvaginal.

Clinical Application for 6.5EV13 Curved Array Transducer:
Small Organ (breast, testes, thyroid, penis, prostate), Neonatal, Transrectal, Transvaginal.

Clinical Application for 7.5C30 Curved Array Transducer:
Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid, penis), Peripheral vessel, Musculo-skeletal Conventional.

Clinical Application for 7.5L40 Linear Array Transducer:
Fetal, Abdominal, Intraoperative (abdominal, neurological), Pediatric, Small Organ (breast, testes, thyroid, penis), Neonatal, Peripheral vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

Clinical Application for 7.5PL13 Phased Array Transducer:
Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid, penis), Neonatal, Peripheral vessel, Musculo-skeletal Conventional.

Product codes

90-IYN, 90-IYO, 90-ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic Pulsed Doppler Imaging, Ultrasonic Pulsed Echo Imaging

Anatomical Site

Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular.

Indicated Patient Age Range

Neonatal, Adult. No other specific age ranges mentioned.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K973767, K945072

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

0

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 (425) 557-1629

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 SystemFR # 892.1550 Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging SystemFR # 892.1560 Product Code 90-IYO
Diagnostic Ultrasound TransducerFR # 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

2

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

3

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 (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 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 (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 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

4

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 OperationClinical ApplicationABMPWDCWDColor DopplerAmplitude DopplerColor Velocity ImagingCombined (Specify)Harmonic Imaging
Ophthalmic
FetalPPPPPPPBMDC (P)N
AbdominalPPPPPPPBMDC (P)N
Intraoperative
(Specify) *PPPPPPPBMDC (P)
PediatricPPPPPPPBMDC (P)N
Small Organ
(Specify) **PPPPPPPBMDC (P)N
Neonatal
CephalicPPPPPPPBMDC (P)
Adult CephalicPPPPPPPBMDC (P)
CardiacPPPPPPPBMDC (P)N
Trans-esophageal
TransrectalPPPPPPPBMDC (P)
TransvaginalPPPPPPPBMDC (P)N
Transurethral
Intravascular
Peripheral
vesselPPPPPPPBMDC (P)N
Laparoscopic
Musculo-skeletal
ConventionalPPPPPPPBMDC (P)N
Musculo-skeletal
SuperficialPPPPPPPBMDC (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
ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Harmonic
Imaging
Ophthalmic
FetalP
AbdominalP
Intraoperative
(Specify)P
PediatricP
Small Organ
(Specify)P
NeonatalP
CephalicP
Adult CephalicP
CardiacP
Trans-
esophageal
TransrectalP
TransvaginalP
Transurethral
Intravascular
Peripheral
vesselP
Laparoscopic
Musculo-skeletal
ConventionalP
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)

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
ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Harmonic
Imaging
Ophthalmic
FetalEEEEEEEBMDC (E)N
AbdominalEEEEEEEBMDC (E)N
Intraoperative
(Specify)
PediatricEEEEEEEBMDC (E)N
Small Organ
(Specify)
NeonatalEEEEEEEBMDC (E)
Cephalic
AdultEEEEEEEBMDC (E)
Cephalic
CardiacEEEEEEEBMDC (E)N
Transesophageal
Transrectal
TransvaginalN
Transurethral
Intravascular
Peripheral
vesselEEEEEEEBMDC (E)N
Laparoscopic
Musculo-
skeletal
Conventional
Musculo-
skeletal
Superficial
Other
(Specify)
N = new indication; Additional Comments:
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

Intended Use: See below.
Mode of Operation
Clinical
ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Harmonic
Imaging
Ophthalmic
FetalPPPPPPPBMDC (P)N
AbdominalPPPPPPPBMDC (P)N
Intraoperative
(Specify)
PediatricPPPPPPPBMDC (P)N
Small Organ
(Specify)
Neonatal
CephalicPPPPPPPBMDC (P)
Adult CephalicPPPPPPPBMDC (P)
Cardiac
Trans-
esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral
vesselPPPPPPPBMDC (P)N
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
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)

PPPPPPBMDC (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
ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Harmonic
Imaging
Ophthalmic
FetalEEEEEBMDC (E)N
AbdominalEEEEEBMDC (E)N
Intraoperative
(Specify)
PediatricEEEEEBMDC (E)N
Small Organ
(Specify)
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-
esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral
vesselEEEEEBMDC (E)N
Laparoscopic
Musculo-skeletal
ConventionalEEEEEBMDC (E)N
Musculo-skeletal
Superficial
Other (Specify)
N = new indication;
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 ApplicationABMPWDCWDColor DopplerAmplitude DopplerColor Velocity ImagingCombined (Specify)Harmonic Imaging
Ophthalmic
FetalPPPPPBMDC (P)N
AbdominalPPPPPBMDC (P)N
Intraoperative (Specify)
PediatricPPPPPBMDC (P)N
Small Organ (Specify)
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMDC (P)N
Laparoscopic
Musculo-skeletalPPPPPBMDC (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
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) | | | | | | | | | | |

(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
Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|--------------------------------------|---|---|---|-----|-----|--------------------------------|----------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
(Specify) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) ** | | E | E | E | | E | E | | BMDC (E) | N |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-
esophageal | | | | | | | | | | |
| Transrectal | | E | E | E | | E | E | | BMDC (E) | |
| Transvaginal | | E | E | E | | E | E | | BMDC (E) | N |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral
vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-
skeletal | | | | | | | | | | |
| Conventional
Musculo-
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
ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Harmonic
Imaging
Ophthalmic
Fetal
Abdominal
Intraoperative
(Specify)
Pediatric
Small Organ
(Specify) **PPPPPBMDC (P)N
NeonatalPPPPPBMDC (P)
Cephalic
Adult Cephalic
Cardiac
Trans- esophageal
TransrectalPPPPPBMDC (P)
TransvaginalPPPPPBMDC (P)N
Transurethral
Intravascular
Peripheral
vessel
Laparoscopic
Musculo-
skeletal
Conventional
Musculo-
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
ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Harmonic
Imaging
Ophthalmic
FetalEEEEEBMDC (E)N
AbdominalEEEEEBMDC (E)N
Intraoperative
(Specify)
PediatricEEEEEBMDC (E)N
Small Organ
(Specify) **EEEEEBMDC (E)N
Neonatal
Cephalic
Adult
Cephalic
Cardiac
Trans-
esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral
vesselEEEEEBMDC (E)N
Laparoscopic
Musculo-
skeletalEEEEEBMDC (E)N
Conventional
Musculo-
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)

(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
ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Harmonic
Imaging
Ophthalmic
FetalPPPPPBMDC (P)N
AbdominalPPPPPBMDC (P)N
Intraoperative
(Specify) *PPPPPBMDC (P)
PediatricPPPPPBMDC (P)N
Small Organ
(Specify) **PPPPPBMDC (P)N
NeonatalPPPPPBMDC (P)
Cephalic
Adult Cephalic
Cardiac
Trans-
esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral
vesselPPPPPBMDC (P)N
Laparoscopic
Musculo-
skeletal
ConventionalPPPPPBMDC (P)N
Musculo-
skeletal
SuperficialPPPPPBMDC (P)N
Other (Specify)
N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

  • = intraoperative (abdominal, neurological)

** =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 le Symm

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

15

510 (k) Number (if known) :

Device Name : Intended Use:

K981528 7.5PL13 Phased Array Transducer for use with SONOLINE Elegra/Elegra Advanced 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 | | E | E | E | E | E | E | | BMDC (E) | N |
| Abdominal | | E | E | E | E | E | E | | BMDC (E) | N |
| Intraoperative
(Specify) | | | | | | | | | | |
| Pediatric | | E | E | E | E | E | E | | BMDC (E) | N |
| Small Organ
(Specify) ** | | E | E | E | E | E | E | | BMDC (E) | N |
| Neonatal | | E | E | E | E | E | E | | BMDC (E) | |
| Cephalic | | | | | | | | | | |
| Adult | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-
esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral
vessel | | E | E | E | E | E | E | | BMDC (E) | N |
| Laparoscopic
Musculo-
skeletal | | E | E | E | E | E | E | | BMDC (E) | N |
| Conventional
Musculo-
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)

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

Gavid G. Sigman
(Division Sign Off)

eproductive, Abdominal, EN and R 510(k) Number