Ultrasound imaging, measurement and analysis of the human body as follows: Abdominal/GYN; Urology; Fetal/OB; Small Organ (breast, testes, thyroid); Pediatric; Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal (conventional & superficial); Transesophageal; Intraoperative (abdominal, thoracic and PV); Transvaginal and Transrectal, Intra-cardiac and intra-luminal applications.

Device Description

The Vivid-i and Vivid-q are compact and portable diagnostic ultrasound systems with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. They have an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm high in transport configuration and provide digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

AI/ML Overview

The provided text is a 510(k) Summary for the GE Healthcare Vivid i/q Diagnostic Ultrasound System. It is primarily focused on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance criteria and a study to prove those criteria.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" is largely not present in the provided document. The 510(k) summary explicitly states:

"The subject of this premarket submission, the modified Vivid i/q, did not require clinical studies to support substantial equivalence." (Page 3)

However, I can extract the following relevant details from the document:

1. A table of acceptance criteria and the reported device performance:

Since no clinical studies were performed to establish new acceptance criteria and performance metrics for the modified Vivid i/q, a table of specific clinical performance acceptance criteria and reported device performance cannot be generated from this document. The document instead relies on substantial equivalence to predicate devices, implying that their performance characteristics are maintained.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No clinical test sets were used for this 510(k) submission, as explicitly stated above. Therefore, details regarding sample size and data provenance are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable, as no clinical test sets requiring expert-established ground truth were used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical test sets requiring adjudication were used.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This submission is for an ultrasound system, not an AI-assisted diagnostic tool. No MRMC studies were conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This submission is for an ultrasound system, which inherently involves human operation and interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable, as no clinical studies requiring new ground truth establishment were performed for this submission. The ground truth for the predicate devices would have been established through clinical validation relevant to diagnostic ultrasound.

8. The sample size for the training set:

Not applicable, as this submission is for a medical device (ultrasound system), not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as this submission is for a medical device (ultrasound system), not a machine learning algorithm.

Summary of Non-Clinical Tests (from Page 3 of the document for completeness, as this is the closest to "performance"):

The document highlights the following non-clinical evaluations to ensure safety and effectiveness:

Acoustic output
Biocompatibility
Cleaning and disinfection effectiveness
Thermal, electrical, electromagnetic, and mechanical safety

These tests comply with applicable medical device safety standards and voluntary standards. 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)
Final Acceptance Testing (Validation)
Performance testing (Verification)
Safety testing (Verification)

The biocompatibility of transducer materials and other patient contact materials was also confirmed.

Summary

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K102388 NOV - 4 2010

ું ﻨﻪ

Section 5 — 510(k) Summary

Vivid i/q

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GE Healthcare

Image /page/1/Picture/1 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 and connected, creating a unique and recognizable design.

510(k) Premarket Notification Submission Vivid i/q Ultrasound System August 18, 2010

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	18th August 2010
Submitter:	GE Healthcare [GE Medical Systems Ultrasound and Primary CareDiagnostics, LLC]
	9900 Innovation DrWauwatosa, WI 53226
Primary Contact Person:	Bryan BehnRegulatory Affairs ManagerGE Healthcare, [GE Medical Systems Ultrasound and Primary CareDiagnostics, LLC]T:(414)721-4214F:(414)918-8275GE Healthcare
Secondary Contact Person:	Jim TurnerRegulatory Affairs Manager America's ServiceGE Healthcare, [GE Medical Systems Ultrasound and Primary CareDiagnostics, LLC]T:(262) 544-3359F:(414)908-9225
Device:Trade Name:	Vivid i and Vivid q Diagnostic Ultrasound System
Common/Usual Name:	Vivid i, Vivid q
Classification Names:	Class II
Product Code:	Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN
	Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYODiagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):	Vivid i and Vivid q Diagnostic Ultrasound Systems K092140 andVivid S5 and Vivid S6 Diagnostic Ultrasound Systems K092079,currently in commercial distribution.
Device Description:	The Vivid-i and Vivid-q are compact and portable diagnosticultrasound systems with integrated keyboard, fold-up LCD typedisplay and interchangeable electronic-array transducers. They havean overall size approximately 36 cm wide, 31.5 cm deep and 6 cmhigh in transport configuration and provide digital acquisition,processing and display capability. The user interface includes acomputer keyboard, an intuitive layout of specialized controls, color

GUI display and Doppler audio.

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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 within a circular border. The letters and the border are black, creating a strong contrast against the white background.

The current modifications do not change the indications for use. Intended Use: As previously reported and cleared, the Vivid i/q ultrasound systems are intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdominal/GYN; Urology; Fetal/OB; Small Organ (breast, testes, thyroid); Pediatric; Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal (conventional & superficial); Transesophageal; Intraoperative (abdominal, thoracic and PV); Transvaginal and Transrectal, Intra-cardiac and intra-luminal applications.

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Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circular border. The letters and the border are in black, contrasting with the white background.

Technology: The modified Vivid i/q employs the same fundamental scientific technology as its predicate devices.

Comparison with the predicate device shows the modified Vivid i/q is of a comparable type and substantially equivalent to the current Vivid i/q. It has the same overall characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and operating modes as the predicate device.

Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards. The modified Vivid i/q and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket 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) .
Final Acceptance Testing (Validation) .
Performance testing (Verification) �
Safety testing (Verification) .

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, the modified Vivid i/q, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the modified Vivid i/q to be as safe, and effective as the predicate device(s). The performance of the modified Vivid i/q is substantially equivalent to the predicate device(s). Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21

CFR 820, and ISO13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the Vivid i/q Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

Determination of Substantial Equivalence:

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

NOV - 4 2010 Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare (GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC) 9900 Innovation Dr. WAUWATOSA W1 53226

Re: K102388

Trade/Device Name: Vivid i and Vivid q Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: October 4, 2010 Received: October 5, 2010

Dear Mr. Behn:

We have reviewed your Section 510(k) premarket 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 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the Vivid i and Vivid q Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

9L-RS
E8C-RS
6Tc-RS
6T-RS

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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. 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); 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.

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), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

If you have any questions regarding the content of this letter, please contact Jana Delfino at (301) 796-6503.

Sincerely yours,

David G. Brown, Ph.D.

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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K102387

NOV - 4 2010

510(k) Number (if known):

Device Name: Vivid i/q

Indications for Use:

The current modifications do not change the indications for use. As previously reported and cleared, the Vivid i/q ultrasound systems are intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdominal/GYN; Urology; Fetal/OB; Small Organ (breast, testes, thyroid); Pediatric; Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal (conventional & superficial); Transesophageal; Intraoperative (abdominal, thoracic and PV); Transvaginal and Transrectal, Intra-cardiac and intra-luminal applications.

Prescription Use	X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use	____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________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____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ and the other one. (Part 21 CFR 801 Subpart C)	(Part 21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K102388

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular shape. The letters and the circle are in black, contrasting with the white background.

Diagnostic Ultrasound Indications for Use Form

Vivid i and Vivid a Diagnostic Ultrasound System

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse†	Other
Ophthalmic
Fetal/Obstetrics	P	P	P	P	P	P	P	P	P	P	P
Abdominal[1]	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 (specify)[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
Other[4]	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	N
Transrectal
Transvaginal	P	P	P	P	P	N	P	P	P	N
Transuretheral
Intraoperative (specify)[5]	P	P	P	P	P	P	P	P	P	P
Intraoperative Neurological
Intracardiac and Intraluminal	P	P	P	P	P	P	P	P	P	P
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.
[2] Small organ includes breast, testes, thyroid.

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

[2] Small organ includes breast, testes, etc.
[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

[t] Coded Pulse includes Coded Octave Imaging (COI), and Coded Phase Inversion (CPI),

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

510K

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription User (Per 21 CFR 801.109)

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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 frame. The frame has a decorative, swirling pattern around the letters.

GE Healthcare

510(k) Premarket Notification Submission Vivid i/q Ultrasound System August 18, 2010

Diagnostic Ultrasound Indications for Use Form

Vivid i/q with 9L-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse†	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	P	P	P		P	P	P	P	P	P
Pediatric	P	P	P		P	P	P	P	P	P
Small Organ[2]	P	P	P		P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P	P	P	P	P	P
Musculo-skeletalConventional	P	P	P		P	P	P	P	P	P
Musculo-skeletalSuperficial	P	P	P		P	P	P	P	P	P
Other (specify)
Exam Type, Means ofAccess
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
IntraoperativeNeurological
Intravascular
Laparoscopic

E = added under Appendix E

Notes: [1] Abdominal includes GYN/Pelvic and Renal.
- [2] Small organ includes breast, testes, thyroid.
- [*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.

[T] Coded Pulse is for digitally encoded harmonics.

(Division Sign-Off) (Division of Radiological Devices

510K. K102388

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white.

Diagnostic Ultrasound Indications for Use Form

Vivid i/a with E8C-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation									Other
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging		CodedPulse†
Ophthalmic
Fetal / Obstetrics	P	P	P		P*	N	P	P	P	P*
Abdominal[1]	P	P	P		P*	N	P	P	P	P*
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other[4]	P	P	P		P	P*	P	P	P	P*
Exam Type, Means ofAccess
Transesophageal
Transrectal
Transvaginal	P	P	P		P	P*	P	P	P	P*
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

= previously cleared by FDA on Vivid i/q (K033139) P = previously cleared by FDA on Vivid S5/S6 (K092079)); E = added under Appendix E

Notes: [1] Abdominal includes GYN/Pelvic and Renal.

[4] Other use includes Urology.

(Division Sign-Off) Division of Radiological Devices

4] Other use includes Urology.

Office of In Vitro Diagnostic Devicess
Office of In Vitro Diagnostic Device Evaluation and ! (*) Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.

510K

[T] Coded Pulse is for digitally encoded harmonics.

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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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.

510(k) Premarket Notification Submission Vivid i/q Ultrasound System August 18, 2010

Diagnostic Ultrasound Indications for Use Form

Vivid i/a with 6Tc-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [3]	P	P	P	P	P	P	P	P	P	P*
Peripheral Vascular
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other
Exam Type, Means ofAccess
Transesophageal	P	P	P	P	P	P	P	P	P	P*
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication;

P = previously cleared by FDA, P* = previously cleared by FDA on Vivid S5/S6 (K092079))

E = added under Appendix E

Notes:

[3] Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.

[T] Coded Pulse is for digitally encoded harmonics.

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safe

510K K102388

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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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 circle. The letters and the circle are black, and the background is white.

Diagnostic Ultrasound Indications for Use Form ·

Vivid i/q -with 6T-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes *	HarmonicImaging	CodedPulse
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [3]	P	P	P	P	P	P	P	P	P	P*
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P*
Transrectal
Transvaginal
Transurethral
Intraoperative (specify) [5]
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication;

P = previously cleared by FDA, P* = previously cleared by FDA on Vivid S5/S6 (K092079));

E = added under Appendix E

Notes:

[3] Cardiac is Adult and Pediatric.

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.

[T]Coded Pulse is for digitally encoded harmonics.

(Division Sign-Off)
Division of Radiological Devices
Office of in Vitro Diagnostic Device Evaluation and Safety
K102388
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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.