LOGIQ E
Device Facts
| Record ID | K133533 |
|---|---|
| Device Name | LOGIQ E |
| Applicant | GE Healthcare |
| Product Code | IYN · Radiology |
| Decision Date | Feb 12, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The LOGIQ e is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transrectal; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve Block; Vascular Access).
Device Story
LOGIQ e is a portable, laptop-style diagnostic ultrasound console (approx. 70mm x 295mm x 346mm) with integrated keyboard, LCD display, and interchangeable electronic-array transducers. It performs digital acquisition, processing, and display of ultrasound signals. Operated by clinicians in clinical settings, it supports multiple imaging modes (B, M, PW, CW, Color, PDI, Harmonic, Coded Pulse). The device provides real-time imaging, fluid flow analysis, and measurements to assist in diagnostic assessment and interventional guidance (e.g., nerve blocks, vascular access). Output is displayed on the integrated screen for physician review, facilitating clinical decision-making and procedural guidance. It operates via battery or external power supply.
Clinical Evidence
No clinical studies were required to support substantial equivalence. The device relies on bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing in compliance with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, and NEMA UD 2/UD 3 standards.
Technological Characteristics
Laptop-style ultrasound console; electronic-array transducers; digital acquisition/processing; battery or AC power. Materials are biocompatible. Imaging modes: B, M, PW, CW, Color, PDI, Harmonic, Coded Pulse. Connectivity: DICOM. Safety standards: AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 2, NEMA UD 3, ISO 10993-1, ISO 14971.
Indications for Use
Indicated for ultrasound imaging, measurement, and analysis of human anatomy across various clinical applications including Ophthalmic, Fetal/OB, Abdominal, Pediatric, Small Organ, Neonatal/Adult Cephalic, Cardiac, Peripheral Vascular, Musculoskeletal, and interventional guidance (e.g., nerve block, vascular access).
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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KB35533
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#### 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: November 15, 2013 Date: Submitter: GE Healthcare 9900 Innovation Drive Wauwatosa, WI 53226 Primary Contact Person: Bryan 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 LOGIQ e Diagnostic Ultrasound System Device: Trade Name: Common/Usual Name: LOGIO e Class II Classification Names: Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN Product Code: Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-1YO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX LOGIQ i/e, Vivide - K113690 Predicate Device(s): LOGIQ S8 -- K131527 SonoSite Edge - K113156 Voluson S6/S8 - K120741 Device Description: The LOGIQ e device is a laptop ultrasound console approximately 70mm in height, 295mm in width and 346mm in
length with integrated keyboard, a color video LCD type display and several interchangeable electronic-array transducers. It has digital acquisition. processing and display capability and operates from an integrated battery or a separate power supply/charger.
Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Intended Use: Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transrectal; Transvaginal; Intraoperative (abdominal, thoracic and
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular shape, and there are decorative swirls or flourishes around the outer edge of the circle.
peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve Block; Vascular Access).
The LOGIO e employs the same fundamental scientific Technology: technology as its predicate devices.
Determination of Substantial Equivalence:
Comparison to Predicate Devices
The LOGIQ e 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 e and predicate LOGIQ e systems have the same clinical intended use with the exception of Ophthalmic which is substantially equivalent to Ophthalmic on the SonoSite Edge (K113156) and the transesophageal application has been removed from the new version of the LOGIQ e.
- . The LOGIO e and predicate LOGIO e systems have the same imaging modes.
- The LOGIQ e and predicate LOGIO e systems . transducers are identical accept for the C1-5-RS and 3Sc-RS which are the same transducers on predicate Voluson S6/S8 (K120741), and the L4-12t-RS and L10-22-RS. which are linear transducers similar to the L8-18i-RS.
- 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.
- . The LOGIQ e and predicate LOGIQ e systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. TVD and High-Res PDI are similar to predicate LOGIQ S8 (K131527).
- The LOGIQ e and predicate systems have been designed . in compliance with approved electrical and physical safety standards.
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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, which has a slightly textured or shaded appearance.
### Summary of Non-Clinical Tests:
been evaluated for acoustic output. The device has biocompatibility. cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to comply with applicable medical device safety standards. The LOGIQ e and its applications comply with voluntary standards:
- 1. AAMI/ANSI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety
- 2. JEC60601-1-2. Medical Electrical Equipment -Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- 3. IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- 4. NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 5. ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
- 6. NEMA UD 2. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- 7. ISO14971. Application of risk management to medical devices
- 8. NEMA. Digital Imaging and Communications in Medicine (DICOM) Sct. (Radiology)
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)
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K1335533
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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 e, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the LOGIQ e to be as safe, as effective, Conclusion: and performance is substantially equivalent to the predicate device(s).
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2014
GE Healthcare % Mr. Bryan Behn Regulatory Affairs Manager 9900 Innovation Drive WAUWATOSA WI 53226
Re: K133533
Trade/Device Name: GE LOGIQ e Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 3, 2014 Received: January 6, 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, listing 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 e Diagnostic Ultrasound System, as described in your premarket notification:
| Transducer Model Number | |
|-------------------------|-----------|
| C1-5-RS | 8C-RS |
| E8C-RS | 9L-RS |
| 12L-RS | L4-12t-RS |
| L8-18i-RS | L10-22-RS |
| 3Sc-RS | 6S-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
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Page 2-Mr. Bryan Behn
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.
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/Resources/or You/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/Reportal?rgblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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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K133533 510(k) Number (if known):
Device Name: LOGIQ e
Indications for Use:
The LOGIQ e is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast. testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve Block; Vascular Access).
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
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)
Janningh. Marge
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(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health K133533 510(k)
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## Diagnostic Ultrasound Indications for Use Form GE LOGIQ e Ultrasound
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|----|----|-------|------------|-----|-------------------|---------------------|----------------|-------|--|
| Clinical Application | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | N | N | N | N | N | N | N | N | N | N | N | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P | |
| Abdominal1 | P | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P | |
| Small Organ [2] | P | P | P | P | P | P | P | P | P | P | P | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | P | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | P | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | P | |
| Thoracic/Pleural(specify)[4] | P | P | P | P | P | P | P | P | P | P | P | |
| Other[5] | P | P | P | P | P | P | P | P | P | P | P | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | P | P | P | P | P | P | P | P | P | P | | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | | |
| Intraoperative(specify)[4] | P | P | P | P | P | P | P | P | P | P | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | P | P | P | P | P | P | P | P | P | P | P | |
| Vascular Access (IV, PICC) | P | P | P | P | P | P | P | P | P | P | P | |
| Nerve Block | P | P | P | P | P | P | P | P | P | P | P | |
N = new indication: P = previously cleared by FDA KI13690
Notes: [1] Abdominal includes GYN and Urological:
2 ] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
[6] Intraoperative includes abdominal, thoracic and peripheral;
[ * ] Combined modes are B/M. B/PWD. B/Color/PWD, B/Power/PWD
['] Coded Pulse is for digitally encoded harmonics.
(PLEASE DU NOT WRITE BELOW THIS LINE - CONTINUE ON ANDTHER 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 12
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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white.
#### Diagnostic Ultrasound Indications for Use Form
#### GE LOGIQ e with C1-5-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-----------------------------------|-------------------|---|----|----|-------|------------|-----|-------------------|---------------------|----------------|-------|--|
| Clinical Application | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other | |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | P | P | | |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | | |
| Pediatric | P | P | P | | P | | P | P | P | P | | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | P | | |
| Musculo-skeletal Superficial | N | N | N | | N | | N | N | N | N | | |
| Thoracic/Pleural(specify)[4] | | | | | | | | | | | | |
| Other[5] | | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative(specify)[6] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | N | N | N | | N | | N | N | N | N | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |
| Nerve Block | N | N | N | | N | | N | N | N | N | | |
N = new indication: P = previously cleared by FDA (K120741)
[ I ] Abdominal includes GYN and Urological: Notes:
[2] Small Organ includes breast, testes, thyroid:
[3] Cardiac is Adult and Pediatric:
[4] For detection of Nuid and pleural motion/sliding:
[5] Other use includes Urology/Prostate
(6) Intraoperative includes abdominal, thoracic and peripheral;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
['] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW TISIS 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 12
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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined in a stylized monogram. The monogram is enclosed within a circular border. The logo is presented in black and white, with the monogram and border appearing in black against a white background.
### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ e with 8C-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-----------------------------------|-------------------|---|----|----|-------|------------|-----|-------------------|---------------------|----------------|-------|--|
| Clinical Application | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other | |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | | |
| Ophthalmic | N | N | N | | N | | N | N | N | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | P | P | P | | P | | P | P | P | | | |
| Pediatric | P | P | P | | P | | P | P | P | | | |
| Small Organ [2] | P | P | P | | P | | P | P | P | | | |
| Neonatal Cephalic | P | P | P | | P | | P | P | P | | | |
| Adult Cephalic | N | N | N | | N | | N | N | N | | | |
| Cardiac[3] | P | P | P | | P | | P | P | P | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | | | |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | P | | | |
| Thoracic/Pleural(specify)[4] | P | P | P | | P | | P | P | P | | | |
| Other[5] | | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative(specify)[6] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | P | P | P | | P | | P | P | P | | | |
| Nerve Block | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (KI 13690)
[1] Abdominal includes GYN and Urological: Notes:
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] For detection of fluid and pleural motion/sliding:
[5] Other use includes Urology/Prostate
[6] Intraoperative includes abdominal, thoracic and peripheral;
[*]Combined modes are B/M, B/PWD, B/Color/PWD. B/Power/PWD
" ] Coded Pulse is for digitally encoded harmonics.
(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 4 of 12
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Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.
### Diagnostic Ultrasound Indications for Use Form
#### GE LOGIO e with E8C-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|----|----|-------|------------|-----|-------------------|---------------------|----------------|-------|--|
| Clinical Application | B | M | PW | CW | Color | Color<br>િ | PDI | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | P | | | |
| Abdominal("I | P | P | P | | P | | P | P | P | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ 121 | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiacli | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Thoracic/Pleural(specify) 4) | | | | | | | | | | | | |
| Other 15 | P | P | P | | P | | P | P | P | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | P | | | |
| Transvaginal | P | P | P | | P | | P | P | P | | | |
| Intraoperative(specify)[6] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | P | P | P | | P | | P | P | P | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |
| Maria Rinak | | | | | | | | | | | | |
N = new indication: P = previously cleared by FDA(K113690)
[I] Abdominal includes GYN and Urological: Notes:
[2] Small Organ includes breast, testes, thyroid;
|3| Cardiac is Adult and Pediatric:
[4] For detection of fluid and pleural motion/sliding:
|5} Other use includes Urology/Prostate
[6] Intraoperative includes abdominal, thoracic and peripheral:
[0] : muuoperative modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
*] Coded Pulse is for digitally encoded harmonics.
(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 12
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines, giving the logo a classic and recognizable appearance.
### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ e with 9L-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|----|----|-------|------------|-----|-------------------|---------------------|----------------|-------|--|
| Clinical Application | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | | |
| Pediatric | P | P | P | | P | | P | P | P | P | | |
| Small Organ[2] | P | P | P | | P | | P | P | P | P | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[1] | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | P | P | | |
| Thoracic/Pleural(specify)[4] | P | P | P | | P | | P | P | P | P | | |
| Other[5] | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative(specify)[6] | P | P | P | | P | | P | P | P | P | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | P | P | P | | P | | P | P | P | | | |
| Vascular Access (IV, PICC) | P | P | P | | P | | P | P | P | | | |
| Nenio Alack | P | P | P | | P | | P | P | P | | | |
N = new indication: P = previously cleared by FDA(K | 13690)
Notes: [1] Abdominal includes GYN and Urological:
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric:
[4] For detection of tluid and pleural motion/sliding:
[5] Other use includes Urology/Prostate
[6] Intraoperative includes abdominal, thoracic and peripheral;
[*]Combined modes are B/M, B/PWD. B/Color/PWD. B/Power/PWD
(') Coded Pulse is for digitally encoded harmonics.
IPLEASE DO NOT WRITE BELOW THIS I.INE - CONTINUI: ON ANOTHER PAGE IF NEEDED I
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 6 of 12
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines, giving the logo a classic and recognizable appearance. The image is simple and clear, focusing on the iconic GE brand symbol.
### Diagnostic Ultrasound Indications for Use Form
### GE LOGIO e with 12L-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|----|----|-------|------------|-----|-------------------|---------------------|----------------|-------|--|
| | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other | |
| Anatomy Region of Interest | | | | | | | | | | | | |
| Ophthalmic | N | N | N | | N | | N | N | N | N | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | | |
| Pediatric | P | P | P | | P | | P | P | P | P | | |
| Small Organ [2] | P | P | P | | P | | P | P | P | P | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | P | P | | |
| Thoracic/Pleural(specify)[4] | P | P | P | | P | | P | P | P | P | | |
| Other[5] | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative(specify)[4] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | P | P | P | | P | | P | P | P | P | | |
| Vascular Access (IV, PICC) | P | P | P | | P | | P | P | P | P | | |
| Nerve Block | P | P | P | | P | | P | P | P | P | | |
N = new indication: P = previously cleared by FDA (K113690)
| | | Abdominal includes (iYN and Urological: Noles:
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric:
[4] For detection of fluid and pleural motion/sliding:
[5] Other use includes Urology/Prostate
[6] Intraoperative includes abdominal. thoracic and peripheral;
[*]Combined modes are B/M, B/PWD, B/Color/PWD. B/Power/l'WD
['] Coded Pulse is for digitally encoded harmonics.
(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 7 of 12
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white and appears to be a vintage or classic version of the GE logo.
#### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ e with L4-12t-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | Other |
|-----------------------------------|-------------------|---|----|----|-------|------------|-----|-------------------|---------------------|-------|
| | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes | Harmonic<br>Imaging | |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | |
| Ophthalmic | N | N | N | | N | | N | N | N | |
| Fetal / Obstetrics | | | | | | | | | | |
| Abdominal1 | | | | | | | | | | |
| Pediatric | N | N | N | | N | | N | N | N | |
| Small Organ l2l | N | N | N | | N | | N | N | N | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiacl3l | | | | | | | | | | |
| 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)l4l | N | N | N | | N | | N | N | N | |
| Othersl5l | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Intraoperative(specify) l6 | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | N | N | N | | N | | N | N | N | |
| Vascular Access (IV, PICC) | N | N | N | | N | | N | N | N | |
| Nerve Block | N | N | N | | N | | N | N | N | |
N = new indication
[1] Abdominal includes GYN and Urological: Notes:
[2] Small Organ includes breast. testes. thyroid:
[3] Cardiac is Adult and Pediatric:
[4] For detection of fluid and pleural motion/sliding:
[5] Other use includes Urology/Prostate
[6] Intraoperative includes abdominal, thoracic and peripheral:
* |Combined modes are B/M, R/PWD, B/Color/PWD, B/Power/PWD
* | Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDEDI
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 8 of 12
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' in a stylized, cursive font. The letters are intertwined and surrounded by a circular border. The logo appears to be a vintage or classic design.
### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ e with L8-18i-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|----|----|-------|------------|-----|-------------------|---------------------|----------------|-------|--|
| | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | | |
| Pediatric | P | P | P | | P | | P | P | P | P | | |
| Small Organ [2] | P | P | P | | P | | P | P | P | P | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | P | P | | |
| Thoracic/Pleural(specify)[4] | P | P | P | | P | | P | P | P | P | | |
| Other[5] | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative(specify)[4] | N | N | N | | N | | N | N | N | N | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | P | P | P | | P | | P | P | P | P | | |
| Vascular Access (IV, PICC) | P | P | P | | P | | P | P | P | P | | |
| Nerve Block | P | P | P | | P | | P | P | P | P | | |
N = new indication; P = previously cleared by FDA (KI 13690)
Notes: [1] Abdominal includes GYN and Urological:
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] For detection of fluid and pleural motion/sliding:
[5] Other use includes Urology/Prostate
[6] Intraoperative includes abdominal, thoracic and peripheral;
* JCombined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
* | Coded Pulse is for digitally encoded harmonics.
(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 9 of 12
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The design is simple and recognizable, representing the company's brand identity.
## Diagnostic Ultrasound Indications for Use Form
## GE LOGIQ e with L10-22-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|----|----|-------|------------|-----|--------------------|---------------------|-----------------|-------|--|
| | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ[2] | N | N | N | | N | | N | N | N | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| 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)[4] | | | | | | | | | | | | |
| Other[5] | | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative(specify)[4] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | N | N | N | | N | | N | N | N | | | |
| Vascular Access (IV, PICC) | N | N | N | | N | | N | N | N | | | |
| Nerve Block | N | N | N | | N | | N | N | N | | | |
N = new indication
[ ] ] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
[6] Intraoperative includes abdominal, thoracic and peripheral:
* | Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
* | Coded Pulse is for digitally encoded harmonics.
(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 10 of 12
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a circular design with the letters "GE" intertwined in the center. The logo is black and white and has a vintage look.
#### Diagnostic Ultrasound Indications for Use Form
# GE LOGIQ e with 3Sc-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|------------------------------------|-------------------|---|----|----|-------|------------|-----|-------------------|---------------------|----------------|-------|
| | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| <i>Anatomy: Region of Interest</i> | | | | | | | | | | | |
| Ophthalmic | N | N | N | N | N | N | N | N | N | N | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural(specify)[4] | N | N | N | N | N | N | N | N | N | N | |
| Other[5] | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative(specify)[6] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | N | N | N | N | N | N | N | N | N | N | |
| Vascular Access (IV, PICC) | N | N | N | N | N | N | N | N | N | N | |
| Nerve Block | | | | | | | | | | | |
N = new indication: P = previously cleared by FDA(K120741)
[1] Abdominal includes GYN and Urological: Notes:
[2] Small Organ includes breast, testes. thyroid;
[3] Cardiac is Adult and Pediatric;
[4] For detection of fluid and pleural motion/sliding:
[5] Other use includes Urology/Prostate
[6] Intraoperative includes abdominal, thoracic and peripheral:
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
(') Coded Pulse is for digitally encoded harmonics.
(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 11 of 12
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The logo is in black and white, with the letters and border appearing in black against a white background.
#### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ e with 6S-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|----|----|-------|------------|-----|-------------------|---------------------|-----------------|--------|--|
| | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse* | Other* | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal1 | P | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | | |
| Cardiac1 | P | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Thoracic/Pleural(specify)[4] | P | P | P | P | P | P | P | P | P | P | | |
| Other[5] | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative(specify)[4] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | P | P | P | P | P | P | P | P | P | P | | |
N = new indication: P = previously cleared by FDA (KI 13690)
[1] Abdominal includes GYN and Urological: Notes:
[3] Cardiac is Adult and Pediatric;
Prescription Use (Per 21 CFR 801.109)
[4] For detection of fluid and pleural motion/sliding:
(*)Combined modes are B/M. B/PWD, B/Color/PWD. B/Power/PWD. B/Power/PW/D
[4] Coded Pulse is for digitally encoded harmonics.
(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 12 of 12
(Division Sign-Off)
1
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number
Janning H. Morse
27
