LOGIQ F SERIES
Device Facts
| Record ID | K133034 |
|---|---|
| Device Name | LOGIQ F SERIES |
| Applicant | GE Healthcare |
| Product Code | IYN · Radiology |
| Decision Date | Jan 31, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The LOGIQ F SERIES are general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability, clinical applications including: Abdominal, Obstetrical, Gynecological, Small parts, Vascular/Peripheral Vascular, Transcranial, Pediatric, Musculoskeletal, Urological, Cardiac, Transvaginal
Device Story
LOGIQ F Series is a mobile, general-purpose diagnostic ultrasound system; provides digital acquisition, processing, and display of ultrasound images. System includes console with keyboard, color LCD, and touch panel. Operates via various transducers to capture acoustic signals; processes data for B-mode, M-mode, Doppler (PW/CW/Color/Power), and 3D/4D imaging. Used by clinicians in clinical settings for diagnostic imaging and interventional guidance (e.g., biopsy). Output displayed on integrated monitor; assists physicians in clinical decision-making by providing anatomical and physiological visualization. Benefits include non-invasive diagnostic assessment and procedural guidance.
Clinical Evidence
Bench testing only. Evaluation included acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety. System conforms to AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, and ISO 10993-1 standards. No clinical studies were required to support substantial equivalence.
Technological Characteristics
Mobile console with LCD display. Supports multiple transducers (4C-RS, 8C-RS, 3Sc-RS, L6-12-RS, E8C-RS, RAB2-6-RS). Imaging modes: B, M, PW/CW Doppler, Color/Power Doppler, 3D/4D, Elastography, Tissue Velocity Imaging (TVI)/Doppler (TVD), Auto IMT. Connectivity: DICOM. Biocompatible patient-contact materials per ISO 10993-1. Acoustic output compliant with NEMA UD 2/UD 3.
Indications for Use
Indicated for diagnostic ultrasound imaging, measurement, and analysis of human anatomy including abdominal (inc. GYN/Urological), obstetrical, gynecological, small parts (breast, testes, thyroid), vascular/peripheral vascular, transcranial, pediatric, musculoskeletal, urological, and cardiac (adult/pediatric) applications. Includes interventional guidance for tissue biopsy/fluid drainage.
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
Submission Summary (Full Text)
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K133034
Page 1 of 4
# GE Healthcare 510(k) Premarket Notification Submission
#### 510(k) Summary
JAN 3 1 2014
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: December 5, 2013 GE Healthcare Submitter: 9900 Innovation Dr Wauwatosa, WI 53226 Primary Contact Person: Brvan Behn Regulatory Affairs Manager GE Healthcare T:(414)721-4214 F:(414)918-8275 Secondary Contact Person: Jiawei ZHANG Regulatory Affairs GE Healthcare T: +86 510 8527 8259 F: +86 510 8522 7347 Device: Trade Name: LOGIQ F SERIES Common/Usual Name: LOGIQ F8. LOGIQ F6. LOGIQ F5, LOGIQ F3 Classification Names: Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-Product Code: IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-11TX Predicate Device(s): K122387 GE Voluson P8 K131527 GE LOGIQ S8 K113690 LOGIQ e/i, Vivid e Device Description: The LOGIQ F Series is the full featured general purpose diagnostic ultrasound system which consists of a mobile console (Approximately 72 cm wide. 80 cm deep and 145 cm high) that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, color LCD image display and touch panel.
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# GE Healthcare
510(k) Premarket Notification Submission
| Product name | LOGIQ F8 | LOGIQ F6 | LOGIQ F5 | LOGIQ F3 |
|--------------|----------|---------------------|------------------|---------------|
| Imaging | Color | Color | Color | Black & White |
| LCD | 19'LCD | 17'LCD or<br>19'LCD | 17'LCD or 19'LCD | 17'LCD |
#### Main Differences Between Models
The LOGIQ F SERIES is a general purposed ultrasound imaging Intended Use: and analysis systems providing digital acquisition, processing and display capability, clinical applications including: Abdominal, Obstetrical, Gynecological, Small parts, Vascular/Peripheral Vascular, Transcranial, Pediatric, Musculoskeletal, Urological, Cardiac, Transvaginal
The LOGIO F SERIES employs the same fundamental scientific Technology: technology as its predicate devices.
Determination of Substantial Equivalence:
#### Comparison to Predicate Devices
The LOGIQ F Series system is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
- The systems are all intended for diagnostic ultrasound . imaging and fluid flow analysis.
- The LOGIQ F Series and predicate systems have similar . clinical intended use and similar imaging modes.
- . All the transducers used on LOGIO F Series have been cleared on Voluson P8 (K122387) except 8C-RS and L6-12-RS.
- 8C-RS has been cleared on LOGIQ e/i, Vivid e . (K113690).
- . L6-12-RS is a new transducer equivalent to the predicate L8-18-RS on the LOGIQ e/i. Vivide (K113690):
- The systems are manufactured with materials which have . been evaluated and found to be safe for the intended use of the device.
- The systems have acoustic power levels which are below . the applicable FDA limits.
- Elastography. Tissue Velocity Imaging (TVI)/Tissue . Velocity Doppler (TVD), Auto IMT and Quantitative
{2}------------------------------------------------
# GE Healthcare
#### 510(k) Premarket Notification Submission
Analysis have been previously cleared on the LOGIQ S8 (K131527).
The LOGIQ F Series and predicate systems have been designed in compliance with approved electrical and physical safety standards.
#### Summary of Non-Clinical Tests:
The LOGIQ F SERIES has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety. and have been found to conform with applicable medical device safety standards. The LOGIQ F SERIES complies with voluntary standards:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment -. Part 1: General Requirements for Safety
- IEC60601-1-2, Medical Electrical Equipment -. Part l-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- IEC60601-2-37. Medical Electrical Equipment -- Part 2-. 37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- NEMA UD 3, Standard for Real Time Display of Thermal . and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- ISO10993-1, Biological Evaluation of Medical Devices-● Part 1: Evaluation and Testing- Third Edition
- . NEMA UD 2. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- . ISO14971. Application of risk management to medical devices
- NEMA, Digital Imaging and Communications in . Medicine (DICOM) Set. (Radiology)
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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a circular design. The letters are stylized and have a vintage or classic appearance. The logo is black and white.
K133034
Page 4 of 4
# GE Healthcare 510(k) Premarket Notification Submission
The following quality assurance measures were applied to the development of the system:
- Risk Analysis .
- . Requirements Reviews
- . Design Reviews
- Testing on unit level (Module verification) .
- Integration testing (System verification) ●
- Performance testing (Verification)
- . Safety testing (Verification)
- . Simulated use testing (Validation)
Transducer material and other patient contact materials such as needle guidance kits are biocompatible.
#### Summary of Clinical Tests:
The subject of this premarket submission, LOGIQ F Scries, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the LOGIQ F Series to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).
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Page 3—Mr. Behn
# ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
# 510(k) Number: K133034/S002 - GE Healthcare
| Digital Signature Concurrence Table | |
|-------------------------------------|---------------------------------------------------|
| Reviewer Sign-Off | Shahram Vaezy<br>January 30, 2014 |
| Branch Chief Sign-Off | Robert Ochs<br>January 30, 2014 |
| Division Sign-Off | Sean M. Boyd -S<br>2014.01.31<br>15:52:42 -05'00' |
QC: FMEba:fme:1/30/2014
Template Name: OIR Letter Generator v1.10 - Letter type: SE
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2014
GE Healthcare % Mr. Bryan Behn Regulatory Affairs Manager 9900 Innovation Drive WAUWATOSA WI 53226
Re: K133034
Trade/Device Name: LOGIQ F Series Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 22, 2014 Received: January 23, 2014
#### Dear Mr. Behn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the LOGIQ F Series, as described in your premarket notification:
#### Transducer Model Number
| 4C-RS | | . 8C-RS |
|--------|--|-----------|
| 3Sc-RS | | L6-12-RS |
| E8C-RS | | RAB2-6-RS |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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#### Page 2-Mr. Behn
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sm.h.f)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# GE Healthcare 510(k) Premarket Notification Submission
510(k) Number (if known): K133034
Device Name: LOGIQ F Series
Indications for Use:
The LOGIQ F SERIES are general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability, clinical applications including: Abdominal. Obstetrical. Gynecological, Small parts, Vascular/Peripheral Vascular, Transcranial. Pediatric, Musculoskeletal. Urological, Cardiac, Transvaginal
AND/OR
ﺎ
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use N/A (Part 21 CFR 801 Subpart C)
### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Page I of 9
Sm.h.7)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K133034
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# Diagnostic Ultrasound Indications for Use Form LOGIQ F8, F6, F5 Ultrasound Systems
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|------------------------------------|-------------------|---|---------------|----|-------|------------|-------|-------------------|---------------------|----------------|-------|
| | B | M | Doppler Modes | | | | | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| Anatomy/Region of Interest | | | PW | CW | Color | Color<br>M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | N | N | N | N | N | N | N | N | N | N | [5] |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | [5] |
| Pediatric | N | N | N | N | N | N | N | N | N | N | |
| Small Organ (specify)[2] | N | N | N | N | N | N | N | N | N | N | [6] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | N | N | N | N | N | N | N | N | N | N | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | |
| Thoracic/Pleural (specify) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | N | N | | | N | | N | N | N | | |
| Transorbital | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | N | N | | | N | | N | N | N | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[4] | N | N | N | N | N | N | N | N | N | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
| Nonvascular (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA
[1] Abdominal includes GYN and Urological: Notes:
[2] Small Organ includes breast, testes, thyroid:
[3] Cardiac is Adult and Pediatric:
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide:
[5] 3D/4D Imaging Mode
[6] Elastography imaging- Elasticity
[*] Combined modes are color/power Doppler with B-mode
(PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 2 of 9
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# Diagnostic Ultrasound Indications for Use Form
## LOGIQ F3 Ultrasound System
#### Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|---------------------------------|-------------------|---|---------------|----|-------|---------|----------------|------------------|-------------|-------|--|
| Anatomy/Region of Interest | B | M | Doppler Modes | | | | Combined Modes | Harmonic Imaging | Coded Pulse | Other | |
| | | | PW | CW | Color | Color M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | N | N | N | | | | | N | N | | |
| Abdominal[1] | N | | N | | | | | N | N | | |
| Pediatric | N | N | N | N | | | | N | N | | |
| Small Organ (specify)[2] | N | | N | | | | | N | N | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | N | N | N | N | | | | N | N | | |
| Peripheral Vascular | N | | N | | | | | N | N | | |
| Musculo-skeletal Conventional | N | | N | | | | | N | N | | |
| Musculo-skeletal Superficial | N | | N | | | | | N | N | | |
| Thoracic/Pleural (specify) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | N | N | | | | | | N | N | | |
| Transorbital | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | N | N | | | | | | N | N | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage[4] | N | N | N | N | | | | N | N | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
| Nonvascular (specify) | | | | | | | | | | | |
N = new indication: P = previously cleared by FDA
[I] Abdominal includes GYN and Urological: Noles:
[2] Small Organ includes breast. testes, thyroid:
[3] Cardiac is Adult and Pediatric:
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide:
[*] Combined modes are color/power Doppler with B-mode
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 3 of 9
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#### Diagnostic Ultrasound Indications for Use Form
#### LOGIQ F Series with 4C-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|---------------------------------|-------------------|---|----|----|---------------|------------|-------|-------|------------------------------|----------------|-------|
| | B | | | | Doppler Modes | | | Modes | Combined Harmonic<br>lmaging | Coded<br>Pulse | Other |
| Anatomy/Region of Interest | | M | PW | CW | Color | Color<br>M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | P | P | P | | P | P | P | p | P | P | |
| Abdominal 11 | P | | p | | P | | P | P | P | P | |
| Pediatric | P | | P | | P | | P | P | P | P | |
| Small Organ (specify) 21 | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiacli | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-sketctal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural (specify) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage141 | N | N | | | N | | N | N | N | N | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
| Nonvascular (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K 122387)
[1] Abdominal includes GYN and Urological: Notes:
[2] Small Organ includes breast, testes. thyroid:
[3] Cardiac is Adult and Pediatric:
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[*] Combined modes are B/M. B/Color M. B/PWD. B/Color/PWD. B/PWD
(PLEASE DO NOT WATTE: BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 4 of 9
{11}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form LOGIQ F Series with 8C-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|-------------------------------|-------------------|---|---------------|----|-------|---------|-------|----------------|------------------|-------------|-------|
| | | | Doppler Modes | | | | | | | | |
| Anatomy/Region of Interest | B | M | PW | CW | Color | Color M | Power | Combined Modes | Harmonic Imaging | Coded Pulse | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | | | | | | | | | | | |
| Abdominal¹¹ | P | | P | | P | | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Small Organ (specify)²¹ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural (specify) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
| Nonvascular (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA(K113690)
Notes: [1] Abdominal includes GYN and Urological;
[2] Small Organ includes breast, testes, thyroid
[3] Cardiac is Adult and Pediatric;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801,109)
Page 5 of 9
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#### LOGIQ F Series with 3Sc-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---------------|----|-------|------------|--------------------|---------------------|-----------------|-------|
| Anatomy/Region of Interest | B | M | Doppler Modes | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other |
| | | | PW | CW | Color | Color<br>M | | | | |
| Ophthalmic | | | | | | | | | | |
| Fetal/OB | | | | | | | | | | |
| Abdominal1 | P | P | P | | P | P | P | P | P | P |
| Pediatric | P | P | P | | P | P | P | P | P | P |
| Small Organ (specify)2 | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac3 | P | P | P | | P | P | P | P | P | P |
| Peripheral Vascular | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Thoracic/Pleural (specify) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transcranial | P | P | P | | P | P | P | P | P | P |
| Transorbital | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intracardiac | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage4 | N | N | N | | N | N | N | N | N | N |
| Vascular Access (IV, PICC) | | | | | | | | | | |
| Nonvascular (specify) | | | | | | | | | | |
N = new indication: P = previously cleared by FDA(K122387)
Notes: |1| Abdominal includes GYN and Urological
[2] Small Organ includes breast. testes. thyroid
[3] Cardiac is Adult and Pediatric
. ···
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide;
[*] Combined modes are B/M. B/Color M. B/PWD. B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - ('ONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
Prescription Use (Per 21 CFR 801.109)
Page 6 of 9
{13}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form LOGIQ F Series with L6-12-RS Transducer
# Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|-------------------------------|-------------------|---|----|----|---------------|------------|-------|-------------------|---------------------|----------------|-------|
| | | | | | Doppler Modes | | | | Harmonic<br>Imaging | Coded<br>Pulse | |
| Anatomy/Region of Interest | B | M | PW | CW | Color | Color<br>M | Power | Combined<br>Modes | | | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | | | | | | | | | | | |
| Abdominal1 | | | | | | | | | | | |
| Pediatric | N | | N | | N | | N | N | N | N | |
| Small Organ (specify)2 | N | N | N | N | N | N | N | N | N | [6] | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac3 | | | | | | | | | | | |
| Peripheral Vascular | N | | N | | N | | N | N | N | N | |
| Musculo-skeletal Conventional | N | | N | | N | | N | N | N | N | |
| Musculo-skeletal Superficial | N | | N | | N | | N | N | N | N | |
| Thoracic/Pleural (specify) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage4 | N | | N | | N | | N | N | N | N | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
| Nonvascular (specify) | | | | | | | | | | | |
N = new indication: P = previously cleared by FDA
[1] Abdominal includes GYN and Urological: Notes:
[2] Small Organ includes breast, testes, thyroid:
[3] Cardiac is Adult and Pediatric:
[4] Interventional Guidance Tissue Biopsy is 21) biopsy guide
[5] 3D/4D Imaging Mode
[6] Elastography imaging- Elasticity
1* ] Combined modes are B/M. B/Color M. B/PWD. B/Color/PWD. B/PWD
(PLEASE DO NOT WRITE: BELOW THIS I.INE - CONTINUE ON ANOTHER PAGE IF NEEDEDI
Concurrence of CDRH, Office of In Vitro Dlagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 7 of 9
{14}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form LOGIQ F Series with E8C-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|-----------------------------------|-------------------|---|----|----|---------------|---------|-------|-----------------|------------------|--------------|-------|
| | | | | | Doppler Modes | | | | | | |
| <i>Anatomy/Region of Interest</i> | B | M | PW | CW | Color | Color M | Power | Combined Modes* | Harmonic Imaging | Coded Pulse* | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | P | P | P | | P | | P | P | | P | |
| Abdominal11 | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify)12 | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural (specify) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | P | P | P | | P | | P | P | | P | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage[4] | N | N | N | | N | | N | N | | N | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
| Nonvascular (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA(K122387)
Notes: [1] Abdominal includes GYN and Urological:
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
:
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide;
[*] Combined modes are B/M, B/Color M. B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 8 of 9
{15}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form LOGIQ F Series with RAB2-6-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|-------------------------------|-------------------|---|----|----|---------------|------------|-------|-------------------|---------------------|----------------|-------|
| | B | M | PW | CW | Doppler Modes | | | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| Anatomy/Region of Interest | | | | | Color | Color<br>M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal/OB | P | P | P | | P | P | P | P | P | P | [5] |
| Abdominal1 | P | P | P | | P | P | P | P | P | P | [5] |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify)2 | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac3 | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural (specify) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transorbital | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage4 | N | N | N | | N | N | N | N | N | N | [5] |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
| Nonvascular (specify) | | | | | | | | | | | |
N = new indication: P = previously cleared by FDA (K 122387)
|1| Abdominal includes GYN and Urological Noles:
12] Small Organ includes breast, testes: thyroid
[3] Cardiac is Adult and Pediatric
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide:
[5] 3D/4D Imaging Mode
[6] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD. B/Color/PWD, B/PWD
<Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
Prescription Use (Per 21 CFR 801.109)
Page 9 of 9
