Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard diagnostic ultrasound system and does not mention any AI or ML capabilities, training data, or performance metrics typically associated with such technologies.

Therapeutic

No
The provided text indicates that the device is intended for "Diagnostic ultrasound imaging or Doppler analysis," which is a diagnostic use, not therapeutic.

Diagnostic

Yes

The "Intended Use / Indications for Use" directly states "Diagnostic ultrasound imaging or Doppler analysis of the human body". The "Device Description" also refers to it as a "diagnostic ultrasound system".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "mobile console" with physical components like a keyboard, display panel, and monitor, indicating it is a hardware system, not software-only.

IVD (In Vitro Diagnostic)

No, 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 Function: The provided description clearly states that this device is a diagnostic ultrasound system. Ultrasound imaging is a non-invasive technique 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 use describes imaging and Doppler analysis of various anatomical sites within the human body, which is consistent with the function of an ultrasound system, not an IVD.

Therefore, based on the provided information, this device is a diagnostic imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

For transducer 326s: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and other (includes urological), Abdominal, Cardiac Adult, Cardiac Pediatric. Small organ (includes breast, testes, thyroid). Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

For transducer 547L: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and other (includes urological), Musculoskeletal, Small Organ (includes breast, testes, thyroid), Peripheral vessel. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

For transducer 739L: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and other (includes urological), Musculoskeletal, Pediatric, Small Organ (includes breast, testes, thyroid), Peripheral vessel. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

For transducer 618E: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and other (includes urological), Trans-rectal, Trans-vaginal. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

For transducer 618C: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Pediatric, Neonatal Cephalic, Peripheral vessel. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

For transducer 548C: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and other (includes urological), Abdominal, Small Organ (includes breast, testes, thyroid). Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

For transducer 348C: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and other (includes urological), Abdominal, Small Organ (includes breast, thyroid). Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

For transducer 227s: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and other (includes urological), Abdominal, Small Organ (includes breast, testes, thyroid). Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

For transducer 546L: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and other (includes urological), Musculoskeletal, Small Organ (includes breast, testes, thyroid), Peripheral vessel. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

For transducer LA39: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and other (includes urological), Musculoskeletal, Pediatric, Small Organ (includes breast, testes, thyroid), Peripheral vessel. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

For transducer M3C: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and other (includes urological), Abdominal, Small Organ (includes breast, testes, thyroid). Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

For transducer M12L: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and other (includes urological), Musculoskeletal, Small Organ (includes breast, testes, thyroid), Peripheral vessel. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

Product codes (comma separated list FDA assigned to the subject device)

90 IYN

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound imaging

Anatomical Site

Fetal and urological, Musculoskeletal, Abdominal, Pediatric, Small Organ including breast, testes and thyroid, Neonatal Cephalic, Cardiac Adult, Cardiac Pediatric, Trans-rectal, Trans-vaginal, and Peripheral vessel. Specific applications also include: Fetal and other, Musculoskeletal, Pediatric, Small Organ, Neonatal Cephalic, Cardiac Adult, Cardic Pediatric, Trans-rectal, Trans-vaginal, Peripheral vessel.

Transducers and their specific clinical applications:

326s: Fetal and other (urological), Abdominal, Cardiac Adult, Cardiac Pediatric, Small Organ (breast, testes, thyroid).
547L: Fetal and other (urological), Musculoskeletal, Small Organ (breast, testes, thyroid), Peripheral vessel.
739L: Fetal and other (urological), Musculoskeletal, Pediatric, Small Organ (breast, testes, thyroid), Peripheral vessel.
618E: Fetal and other (urological), Trans-rectal, Trans-vaginal.
618C: Pediatric, Neonatal Cephalic, Peripheral vessel.
548C: Fetal and other (urological), Abdominal, Small Organ (breast, testes, thyroid).
348C: Fetal and other (urological), Abdominal, Small Organ (breast, thyroid).
227s: Fetal and other (urological), Abdominal, Small Organ (breast, testes, thyroid).
546L: Fetal and other (urological), Musculoskeletal, Small Organ (breast, testes, thyroid), Peripheral vessel.
LA39: Fetal and other (urological), Musculoskeletal, Pediatric, Small Organ (breast, testes, thyroid), Peripheral vessel.
M3C: Fetal and other (urological), Abdominal, Small Organ (breast, testes, thyroid).
M12L: Fetal and other (urological), Musculoskeletal, Small Organ (breast, testes, thyroid), Peripheral vessel.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Qualified physician

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)

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.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K930768

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

Summary

0

O=i - O - 33

K. Wood

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 Projebt 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 quidelines, 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.

1

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K960527 GE LOGIO 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

618E 348C LA39 326s 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through

Image /page/1/Picture/11 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion. The text is in all caps and is written in a simple, sans-serif font.

SEP - 8 1997

2

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 (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

3

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 (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 at (301) 594-1212.

Sincerely yours,

Elwind h. Segerson

for

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

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:

| 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 | |
| Cardiac Pediatric | | X | X | X | | X | X | | X | |
| Trans-
esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Mode of Operation

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)

David In. Ingram

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

510(k) Number K960527

5

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

Mode of Operation

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. Seysson

(Divis Reproductive, Abdominal, EN Division and Rad 210

6

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	X
Abdominal
Musculoskeletal	X	X	X	X		X	X	X
Intra-operative
Neurosurgical
Pediatric	X	X	X	X		X	X	X
Small Organ
(Specify)	X	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	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)

Daniel Ch. Seymour

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

7

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

Mode of Operation

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)

David A. Segmon

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiolog 510(k) Numb

8

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:

| 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 | | X | X | X | | X | X | | X | |
| 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 | | | | | | | | | | |

Mode of Operation

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. Severson

(Division Reproductive, Abdominal, El Division and Rad 510(k) Number

9

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)

David A. Seymour

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

10

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:

| Clinical
Application | A | B | M | PWD Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|--------------------------|---|---|---| | Opthalmic | | | | | Fetal and other | | X | X | X | | Abdominal | | X | X | X | | Musculoskeletal | | | | | Intra-operative | | | | | Neurosurgical | | | | | Pediatric | | | | | Small Organ
(Specify) | | 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 | | | | | CWD | Color
-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| | | | | | |
| X | X | | X | |
| X | X | | X | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| X | | X | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |

Mode of Operation

Other Indications or Modes: Small organ includes breast, 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)

David A. Seymon

Division on- Off f Reproductive, Abdominal, EN Division and Radiological 510(k) Number

11

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:

| Clinical

Application	A	B	M	PWD	Mode of Operation
					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)

David A. Lyman

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

12

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:

| 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 | | | | | | | | | | |

Mode of Operation

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)

David b. Seymann

(Division Sign-Off) Division Reproductive, Abdominal, EN and F 510(k)

13

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)

David A. Heyman

(Divisio') Reprenuetive, Abdominal, E Division and Radi

510(k) Number K960627

14

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:

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

Mode of Operation

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)

David C. Seymann

(Division Six a- Off) Repreductive, Abdominal, E Division of and Radiolo 510(k) Nu

15

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	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)

Howard W. Diamond

(Division Si Dif) & Representive. Abdominal. Division and Radiological i 510(k) Number