LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM

K960527 · GE Medical Systems · IYN · Sep 8, 1997 · Radiology

Device Facts

• Record ID: K960527
• Device Name: LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM
• Applicant: GE Medical Systems
• Product Code: IYN · Radiology
• Decision Date: Sep 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The modified GE LOGIQ 700 is a general purpose ultrasound imaging system intended for use by or under the direction of a qualified physician for Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and urological, Musculoskeletal, Abdominal, Pediatric, Small Organ including breast, testes and thyroid, Neonatal Cephalic, Cardiac Adult, Cardic Pediatric, Trans-rectal, Trans-vaginal, and Peripheral vessel.

Device Story

Mobile ultrasound console (128-channel) with adjustable keyboard, display panel, and color monitor; utilizes assorted transducers to acquire ultrasound signals. System processes signals for B-mode, M-mode, PWD, Color Doppler, and Power Doppler imaging. Used in clinical settings by physicians or under physician direction. Output displayed on integrated monitor for real-time diagnostic visualization of internal anatomy and blood flow. Assists clinicians in diagnostic assessment of various body systems; supports clinical decision-making through visual analysis of ultrasound data.

Clinical Evidence

Bench testing only. Device evaluated for acoustic output, biocompatibility, and thermal, electrical, and mechanical safety. Conforms to applicable medical device safety standards.

Technological Characteristics

Mobile console (70x120x120 cm); 128-channel architecture; adjustable keyboard/display interface. Supports multiple transducer types. Operates via ultrasound pulse-echo principle. Complies with GMP standards and medical device safety standards.

Indications for Use

Indicated for diagnostic ultrasound imaging and Doppler analysis of fetal, urological, musculoskeletal, abdominal, pediatric, small organ (breast, testes, thyroid), neonatal cephalic, adult/pediatric cardiac, trans-rectal, trans-vaginal, and peripheral vessel applications. Prescription use only.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• GE Medical Systems LOGIQ 700 diagnostic ultrasound system (K930768)

Submission Summary (Full Text)

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027 - 0 00
K960527

# 510(k) Summary of Safety and Effectiveness

Modified GE LOGIQ 700 Premarket Notification K960527

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

**Identification of Submitter:**
GE Medical Systems
PO Box 414
Milwaukee, WI 53201

**Contact:**
D. Duersteler, Safety/Regulatory Projekt Engineer
414-548-4839

**Date Prepared:**
January 30, 1996; Revised July 1, 1997

**Product Identification:** Modified GE LOGIQ 700 Diagnostic Ultrasound System

**Marketed Devices:** The modified GE LOGIQ 700 is of a comparable type and substantially equivalent to the GE Medical Systems LOGIQ 700 diagnostic ultrasound system, 510(k) Number K930768, currently in commercial distribution:

**Device Description:** The modified GE LOGIQ 700 diagnostic ultrasound system consists of a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability, and assorted transducers. The user interface is an adjustable height keyboard, small A/N display panel and a color video display monitor. Optional image storage or hard-copy devices are integrated into the design.

**Indications for Use:** The modified GE LOGIQ 700 is a general purpose ultrasound imaging system intended for use by or under the direction of a qualified physician for Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and urological, Musculoskeletal, Abdominal, Pediatric, Small Organ including breast, testes and thyroid, Neonatal Cephalic, Cardiac Adult, Cardic Pediatric, Trans-rectal, Trans-vaginal, and Peripheral vessel.

**Comparison with Predicate Device:** The modified GE LOGIQ 700 is comparable in key safety and effectiveness features, uses similar design, construction, and materials, and has the same intended uses and operating modes as the predicate device.

**Summary of Studies:** The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.

**Conclusion:** Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with GMP standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the modified GE LOGIQ 700 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP - 8 1997

D. Duersteler
Safety/Regulatory Project Engineer
General Electric Medical Systems
P.O. Box 414
Milwaukee, WI 53201

Re: K960527
GE LOGIQ 700 Diagnostic Ultrasound System
Dated: July 1, 1997
Received: July 2, 1997
Regulatory class: II
21 CFR 892.1550/Procode: 90 IYN

Dear Mr. Duersteler:

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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the modified GE LOGIQ 700 Diagnostic Ultrasound System, as described in your premarket notification:

| Transducer Model Number | | | |
| --- | --- | --- | --- |
| 326s | 618E | 348C | LA39 |
| 547L | 618C | 227s | M3C |
| 739L | 548C | 546L | M12L |

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 Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through

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Page 2 - D. Duersteler

periodic GMP 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.

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 provision of 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 February 17, 1993 “Revised 510(k) Diagnostic Ultrasound Guidance for 1993.” 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

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Page 3 - D Duesteler

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 at [phone].

Sincerely yours,


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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Ultrasound Device Indications Statement
Page 1 of 1

510(k) Number (if known): K960527
Device Name: LOGIQ 700 326s Transducer

Fill out one form for each ultrasound system or transducer

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Opthalmic | | | | | | | | | | |
| Fetal and other | | X | X | X | | X | X | | X | |
| Abdominal | | X | X | X | | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | X | | X | X | | X | |
| Cardic Pediatric | | X | X | X | | X | X | | X | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

(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)


(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K960527

{5}

Ultrasound Device Indications Statement
Page 1 of 1

510(k) Number (if known): K960527
Device Name: LOGIQ 700 547L Transducer

Fill out one form for each ultrasound system or transducer

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Opthalmic | | | | | | | | | | |
| Fetal and other | | X | X | X | | X | X | | X | |
| Abdominal | | | | | | | | | | |
| Musculoskeletal | | X | X | X | | X | X | | X | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | X | X | X | | X | X | | X | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardic Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | X | X | X | | X | X | | X | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

(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 A. Seyman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K960527

{6}

Ultrasound Device Indications Statement
Page 1 of 1

510(k) Number (if known): K960527
Device Name: LOGIQ 700 739L Transducer

Fill out one form for each ultrasound system or transducer

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Opthalmic | | | | | | | | | | |
| Fetal and other | | X | X | X | | X | X | | X | |
| Abdominal | | | | | | | | | | |
| Musculoskeletal | | X | X | X | | X | X | | X | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | X | X | X | | X | X | | X | |
| Small Organ (Specify) | | X | X | X | | X | X | | X | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | X | X | X | | X | X | | X | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

(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)


{7}

Ultrasound Device Indications Statement
Page 1 of 1

510(k) Number (if known): K964886
Device Name: LOGIQ 700 618E Transducer

Fill out one form for each ultrasound system or transducer

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Opthalmic | | | | | | | | | | |
| Fetal and other | | X | X | X | | X | X | | X | |
| Abdominal | | | | | | | | | | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | X | X | X | | X | X | | X | |
| Trans-vaginal | | X | X | X | | X | X | | X | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

(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)


{8}

Ultrasound Device Indications Statement
Page 1 of 1

510(k) Number (if known): K964886
Device Name: LOGIQ 700 618C Transducer

Fill out one form for each ultrasound system or transducer

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Opthalmic | | | | | | | | | | |
| Fetal and other | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | X | X | X | | X | X | | X | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | X | X | X | | X | X | | X | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | X | X | X | | X | X | | X | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

(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 A. Seymon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K960527

{9}

Ultrasound Device Indications Statement
Page 1 of 1

510(k) Number (if known): K960527
Device Name: LOGIQ 700 548C Transducer

Fill out one form for each ultrasound system or transducer

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Opthalmic | | | | | | | | | | |
| Fetal and other | | X | X | X | | X | X | | X | |
| Abdominal | | X | X | X | | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | X | X | X | | X | X | | X | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardic Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

(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)


{10}

Ultrasound Device Indications Statement
Page 1 of 1

510(k) Number (if known): K960527
Device Name: LOGIQ 700 348C Transducer

Fill out one form for each ultrasound system or transducer

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Opthalmic | | | | | | | | | | |
| Fetal and other | | X | X | X | | X | X | | X | |
| Abdominal | | X | X | X | | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | X | X | X | | X | X | | X | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardic Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

(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)


(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K960527

{11}

Ultrasound Device Indications Statement
Page 1 of 1

510(k) Number (if known): K960527
Device Name: LOGIQ 700 227s Transducer

Fill out one form for each ultrasound system or transducer

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Opthalmic | | | | | | | | | | |
| Fetal and other | | X | X | X | | X | X | | X | |
| Abdominal | | X | X | X | | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | X | X | X | | X | X | | X | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardic Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

(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 G. Seyman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K960527

{12}

Ultrasound Device Indications Statement
Page 1 of 1

510(k) Number (if known): K960527
Device Name: LOGIQ 700 546L Transducer

Fill out one form for each ultrasound system or transducer

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Opthalmic | | | | | | | | | | |
| Fetal and other | | X | X | X | | X | X | | X | |
| Abdominal | | | | | | | | | | |
| Musculoskeletal | | X | X | X | | X | X | | X | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | X | X | X | | X | X | | X | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardic Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | X | X | X | | X | X | | X | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

(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 H. Seymm
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K960527

{13}

Ultrasound Device Indications Statement
Page 1 of 1

510(k) Number (if known): K964886
Device Name: LOGIQ 700 LA39 Transducer

Fill out one form for each ultrasound system or transducer

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Opthalmic | | | | | | | | | | |
| Fetal and other | | X | X | X | | X | X | | X | |
| Abdominal | | | | | | | | | | |
| Musculoskeletal | | X | X | X | | X | X | | X | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | X | X | X | | X | X | | X | |
| Small Organ (Specify) | | X | X | X | | X | X | | X | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | X | X | X | | X | X | | X | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

(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 A. Deyrom
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Society
510(k) Number K960527

{14}

Ultrasound Device Indications Statement
Page 1 of 1

510(k) Number (if known): K960527
Device Name: LOGIQ 700 M3C Transducer

Fill out one form for each ultrasound system or transducer

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Opthalmic | | | | | | | | | | |
| Fetal and other | | X | X | X | | X | X | | X | |
| Abdominal | | X | X | X | | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | X | X | X | | X | X | | X | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardic Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

(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)


{15}

Ultrasound Device Indications Statement
Page 1 of 1

510(k) Number (if known): K960527
Device Name: LOGIQ 700 M12L Transducer

Fill out one form for each ultrasound system or transducer

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Opthalmic | | | | | | | | | | |
| Fetal and other | | X | X | X | | X | X | | X | |
| Abdominal | | | | | | | | | | |
| Musculoskeletal | | X | X | X | | X | X | | X | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | X | X | X | | X | X | | X | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardic Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | X | X | X | | X | X | | X | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and Other includes urological. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

(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 L. Lippman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K960527