GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM

K970901 · GE Medical Systems · IYO · Dec 22, 1997 · Radiology

Device Facts

• Record ID: K970901
• Device Name: GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: GE Medical Systems
• Product Code: IYO · Radiology
• Decision Date: Dec 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

LOGIQ 500 is a general purpose ultrasound imaging system intended for use by, or under the direction of, a qualified physician in the evaluation of soft tissue and vascular disease of the head, neck chest, abdomen pelvis, male and female reproductive organs, limbs and pregnant uterus of the adult, pediatric or neonatal patient. Specific intended uses include Abdominal, Peripheral Vascular, OB/Gyn, Small Parts, Musculoskeletal, Urology, Neonatal, Cardiac, Fetal Doppler, Biopsy, Transrectal/transvaginal, Transesophageal, Intra-operative, and Neurosurgical

Device Story

GE LOGIQ 500 is a mobile diagnostic ultrasound system consisting of a console, keyboard, display monitor, and various transducers. It captures ultrasound signals to produce real-time images for clinical evaluation. Operated by physicians or under their direction in clinical settings, the device supports multiple imaging modes including B-mode, M-mode, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), Color Doppler, and Power Doppler. It provides visual and analytical data to assist in diagnosing soft tissue and vascular conditions. The system integrates optional image storage or hard-copy devices. Clinical benefits include non-invasive visualization of internal structures and blood flow, aiding in diagnostic decision-making across various medical specialties.

Clinical Evidence

Bench testing only. The device was evaluated for acoustic output, biocompatibility, and thermal, electrical, and mechanical safety. It was found to conform with applicable medical device safety standards. No clinical study data was required or provided.

Technological Characteristics

Mobile ultrasound console with adjustable keyboard and color display. Supports multiple transducers (e.g., 546L, C364, C386, C551, C721, CWD2, E772, 1739, 739L, L764, T739, CWD5, S220, S316, S317, S611, B510). Imaging modes: B, M, PWD, CWD, Color Doppler, Power Doppler, Color Velocity Imaging. Connectivity includes optional integrated image storage/hard-copy devices. Conforms to GMP and medical device safety standards.

Indications for Use

Indicated for diagnostic ultrasound imaging or Doppler analysis of adult, pediatric, and neonatal patients for evaluation of soft tissue and vascular disease in head, neck, chest, abdomen, pelvis, reproductive organs, limbs, and pregnant uterus. Specific applications include abdominal, peripheral vascular, OB/Gyn, small parts (breast, testes, thyroid), musculoskeletal, urology, neonatal, cardiac, fetal Doppler, biopsy, transrectal/transvaginal, transesophageal, intra-operative, and neurosurgical procedures.

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

• ATL HDI 3000
• GE Medical Systems LOGIQ 500 (K933202)

Submission Summary (Full Text)

{0}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997
DEC 22 1997
K970901

# 510(k) Summary of Safety and Effectiveness: GE LOGIQ 500

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 and Regulatory Programs
414-647-4385

**Date Prepared:**
March 10, 1997

**Product Identification:** GE LOGIQ 500 Diagnostic Ultrasound System with 3D and with neurosurgical intended use.

**Marketed Devices:** The GE LOGIQ 500 Diagnostic Ultrasound System with the described modifications is of a comparable type and substantially equivalent to the ATL HDI 3000 and GE Medical Systems LOGIQ 500 diagnostic ultrasound systems, 510(k) Number K933202, currently in commercial distribution:

**Device Description:** The LOGIQ 500 diagnostic ultrasound system with the described modifications is intended for general radiological and cardiac use and consists of a mobile console 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:** LOGIQ 500 is a general purpose ultrasound imaging system intended for use by, or under the direction of, a qualified physician in the evaluation of soft tissue and vascular disease of the head, neck chest, abdomen pelvis, male and female reproductive organs, limbs and pregnant uterus of the adult, pediatric or neonatal patient. Specific intended uses include Abdominal, Peripheral Vascular, OB/Gyn, Small Parts, Musculoskeletal, Urology, Neonatal, Cardiac, Fetal Doppler, Biopsy, Transrectal/transvaginal, Transesophageal, Intra-operative, and Neurosurgical

**Comparison with Predicate Device:** The GE LOGIQ 500 with 3D is comparable in key safety and effectiveness features, uses the same design, construction, and materials, and has the same features, 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 GE LOGIQ 500 with the described modifications 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

DEC 22 1997

David Duersteler
Safety/Regulatory Project Engineer
GE Medical Systems
P. O. Box 414
Milwaukee, WI 53201

Re: K970901
LOGIQ 500 Ultrasound System
Dated: November 18, 1997
Received: November 19, 1997
Regulatory Class: II
21 CFR 892.1550/Procode 90 IYO

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 LOGIQ 500 Ultrasound System, as described in your premarket notification:

| Transducer Model Number | | | | | |
| --- | --- | --- | --- | --- | --- |
| 546L | C364 | C386 | C551 | C721 | CWD2 |
| E772 | 1739 | 739L | L764 | T739 | CWD5 |
| S220 | S316 | S317 | S611 | B510 | |

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, FDA may publish further announcements concerning your device in the Federal Register.

{2}

Page - 2 - Mr. David Duersteler

*Please note:* this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 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 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 Maureen Butler 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

Enclosure

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GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 C364 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 | | X | |
| Abdominal | | X | X | X | X | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | X | X | X | X | X | X | | X | |
| Small Organ | | X | X | X | X | X | X | | X | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | X | X | X | X | X | X | | X | |
| 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. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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)


{4}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 C386 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 | | X | |
| Abdominal | | X | X | X | X | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | X | X | X | X | X | X | | X | |
| Small Organ | | X | 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. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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 K970901

{5}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 C551 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 | | X | |
| Abdominal | | X | X | X | X | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | X | X | X | X | X | X | | X | |
| Small Organ | | X | X | X | X | X | X | | X | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | X | X | X | X | X | X | | X | |
| Cardiac Adult | | | | | | | | | | |
| Cardic Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | X | X | X | X | X | X | | X | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and other includes urological. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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 K970901

{6}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 C721 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 | | X | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | X | X | X | X | X | X | | X | |
| 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. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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 and Radiological Devices

510(k) Number K970901

{7}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 E721 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 | | X | |
| Abdominal | | | | | | | | | | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardic Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | X | X | X | X | X | X | | X | |
| Trans-vaginal | | X | 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. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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 K970901

{8}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 I739 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 | | X | X | X | X | X | X | | X | |
| Neurosurgical | | X | X | X | X | X | X | | X | |
| Pediatric | | | | | | | | | | |
| Small Organ | | X | 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. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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)


{9}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 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 | | X | |
| Abdominal | | X | X | X | X | X | X | | X | |
| Musculoskeletal | | X | X | X | X | X | X | | X | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | X | 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 | | X | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and other includes urological. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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 K933202

{10}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 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 | | X | |
| Abdominal | | | | | | | | | | |
| Musculoskeletal | | X | X | X | X | X | X | | X | |
| Intra-operative | | X | X | X | X | X | X | | X | |
| Neurosurgical | | X | X | X | X | X | X | | X | |
| Pediatric | | X | X | X | X | X | X | | X | |
| Small Organ | | X | 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 | | X | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and other includes urological. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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)


{11}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 L764 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 | | X | X | X | X | X | X | | X | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | X | 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 | | X | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and other includes urological. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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 K970901

{12}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 T739 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 | | X | X | X | X | X | X | | X | |
| Neurosurgical | | X | X | X | X | X | X | | X | |
| Pediatric | | | | | | | | | | |
| Small Organ | | X | 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. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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 K970901

{13}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 S220 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 | | X | X | X | X | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | X | X | X | X | | X | |
| Cardic Pediatric | | X | 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. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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)


{14}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 S316 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 | | X | X | X | X | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | X | X | X | X | | X | |
| Cardic Pediatric | | X | 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. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 S317 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 | | X | X | X | X | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | X | X | X | X | | X | |
| Cardic Pediatric | | X | 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. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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)


{16}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 S611 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 | | X | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | X | X | X | X | X | X | | X | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | X | X | X | X | | X | |
| Cardic Pediatric | | X | 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. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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)


{17}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Ultrasound Device Indications Statement

510(k) Number (if known): K933202

Device Name: LOGIQ 500 B510 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 | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardic Pediatric | | | | | | | | | | |
| Trans-esophageal | | X | X | X | X | X | X | | X | |
| 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. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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 K97090

{18}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 CWD2 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 | | X | X | X | X | X | X | | X | |
| Musculoskeletal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | X | X | X | X | | X | |
| Cardic Pediatric | | X | 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. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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)


{19}

GE LOGIQ 500 3D Premarket Notification - March 10, 1997

Page 1 of 1

510(k) Number (if known): K933202

Device Name: LOGIQ 500 CWD5 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 | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| 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 | | X | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes: Small organ includes breast, testes, thyroid. Fetal and other includes urological. Intra-operative includes internal abdominal organs.

Combined modes are B/M, B/PWD, B/Color, B/Color /PWD, Color/M.

(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)