GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM

K964886 · GE Medical Systems · IYN · Jul 29, 1997 · Radiology

Device Facts

• Record ID: K964886
• Device Name: GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: GE Medical Systems
• Product Code: IYN · Radiology
• Decision Date: Jul 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GE LOGIQ 700 including intra-operative and neurosurgical uses 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, Abdominal, Intra-operative of abdominal organs, Neurosurgical, Pediatric, Small Organ including breast, testes, thyroid, Neonatal Cephalic, Cardiac Adult, Cardic Pediatric, Trans-rectal, Trans-vaginal, and Peripheral vessel.

Device Story

GE LOGIQ 700 is a mobile diagnostic ultrasound console (128-channel) used in clinical settings by physicians. It processes acoustic signals from transducers to generate real-time images and Doppler analysis. System includes adjustable keyboard, display panel, and color monitor; supports integrated image storage/hard-copy devices. Operates in B, M, PWD, Color Doppler, Power Doppler, and combined modes (B/M, B/Color, B/PWD, B/Color/PWD). Provides diagnostic visualization for fetal, abdominal, neurosurgical, pediatric, small organ, neonatal, cardiac, and vascular applications. Output assists clinicians in diagnostic decision-making and patient assessment.

Clinical Evidence

Bench testing only. Device evaluated for acoustic output, biocompatibility, and thermal, electrical, and mechanical safety. Conformance to applicable medical device safety standards verified through independent evaluation.

Technological Characteristics

Mobile console (70x120x120 cm); 128-channel architecture; ultrasound transducer-based imaging; supports B, M, PWD, Color Doppler, and Power Doppler modes. Integrated keyboard, A/N display, and color video monitor. Compliance with GMP and medical device safety standards.

Indications for Use

Indicated for diagnostic ultrasound imaging or Doppler analysis of human body including fetal, abdominal, intra-operative (abdominal organs), neurosurgical, pediatric, small organ (breast, testes, thyroid), neonatal cephalic, cardiac (adult/pediatric), 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

D. Duersteler
Technology Product Assurance
GE Medical Systems
General Electric Company
P.O. Box 414
Milwaukee, WI 53201

Re: K964886
GE LOGIQ 700 Diagnostic Ultrasound System
Dated: June 18, 1997
Received: June 19, 1997
Regulatory class: II
21 CFR 892.1550/Procode: 90 IYN
21 CFR 892.1570/Procode: 90 ITX

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 GE LOGIQ 700 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number
618C 739I
LA39 739L
739T

JUL 29 1997

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Page 2 - D. Duersteler

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 regulation (CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (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.

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.

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Page 3 - D. Duersteler

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 at [phone].


Enclosure

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K964886
JUL 29 1997
GE Medical Systems

# 510(k) Summary of Safety and Effectiveness: GE LOGIQ 700

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 Project Engineer
414-647-4385

**Date Prepared:**
June 18, 1997

**Product Identification:** GE LOGIQ 700 diagnostic ultrasound system including intra-operative and neurosurgical uses.

**Marketed Devices:** The LOGIQ 700 with intra-operative and neurosurgical uses 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 LOGIQ 700 including intra-operative and neurosurgical uses is the same in all other aspects as the currently marketed LOGIQ 700, consisting 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 GE LOGIQ 700 including intra-operative and neurosurgical uses 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, Abdominal, Intra-operative of abdominal organs, Neurosurgical, Pediatric, Small Organ including breast, testes, thyroid, Neonatal Cephalic, Cardiac Adult, Cardic Pediatric, Trans-rectal, Trans-vaginal, and Peripheral vessel.

**Comparison with Predicate Device:** The LOGIQ 700 including intra-operative and neurosurgical uses is comparable in key safety and effectiveness features, uses the same design, construction, and materials, and has the same operating modes as the predicate device. The intended uses are the same except for the addition of intra-operative use.

**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.

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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 LOGIQ 700 including intra-operative uses is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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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 | | | | | | | | | | |
| Intra-operative | | X | X | X | | X | X | | X | |
| Neurosurgical | | X | X | X | | X | X | | X | |
| 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. Intra-operative includes abdominal organs. 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)