HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac) - Adult/Pediatric, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.

The modes of operation of the HI VISION Ascendus are B mode, M mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Dual Doppler mode, CFI mode (Color Flow Image), Amplitude Dopper (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real-time Virtual Sonography, Real-time Tissue Elastography and Shear Wave Measurement.

Device Description

An ultrasound diagnostic system with the following features:

Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes O
O Ultrasound transducer accessories (standard and optional) - to maximize functional usage of transducer(s) in various modes of operation
O A computer system - to control the transducer and analyze the signals resulting from the reflected echoes
o A video monitor with optional image recorder - to display the computed image or derived Doppler data

AI/ML Overview

The provided document is a 510(k) premarket notification for the Hitachi HI VISION Ascendus ultrasonic pulsed doppler imaging system. It establishes substantial equivalence to legally marketed predicate devices. The document does not contain acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical trial evaluating performance against a predefined metric. Instead, it demonstrates substantial equivalence by comparing the device's features, intended use, and adherence to safety standards with those of predicate devices.

Here's a breakdown of the requested information based on the provided text:

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

The document does not specify quantitative acceptance criteria or a "reported device performance" in terms of clinical accuracy metrics (e.g., sensitivity, specificity, AUC) for the HI VISION Ascendus itself. Instead, the "performance" described is the system's array of features and its substantial equivalence to previously cleared devices.

Here’s a table summarizing the comparison to predicate devices, which serves as the basis for asserting safety and effectiveness:

Feature/Criterion	Predicate Device (HI VISION ASCENDUS (K110673))	Predicate Device (Noblus (K142368))	Predicate Device (Siemens ACUSON S2000/S3000 (K130881))	Subject Device (HI VISION ASCENDUS)
Intended Use	Diagnostic ultrasound evaluation for Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-Vaginal, Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel. Modes: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Harmonic Imaging, Superficial musculoskeletal imaging, 3D Imaging.	Diagnostic ultrasound evaluation for Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Neonatal Cephalic, Adult Cephalic, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications. Modes: B, M, PW, CW, CFI, TDI, Real-time Tissue Elastography.	Applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular.	Diagnostic ultrasound evaluation for Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac) - Adult/Pediatric, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications. Modes: B, M, PWD, CWD, Dual Doppler, CFI, Amplitude Doppler, TDI, 3D Imaging, Real-time Virtual Sonography, Real-time Tissue Elastography and Shear Wave Measurement.
FDA Track	3	3	3	3
Probes	Convex, Linear, Sector, 4D, Other	Convex, Linear, Sector, 4D, Other, EUS	Convex, Linear, Sector, Other	Convex, Linear, Sector, 4D, Other
Display Modes	Combinations of B, M, PW, CW	Combinations of B, M, PW, CW	Unknown	Combinations of B, M, PW, CW
Real-time Tissue Elastography (RTTE) with STRAIN RATIO/STRAIN HISTOGRAM	RTTE only	Real-time Tissue Elastography (RTTE) with STRAIN RATIO/STRAIN HISTOGRAM	Applicable	Real-time Tissue Elastography (RTTE) with STRAIN RATIO/STRAIN HISTOGRAM
SHEAR WAVE ELASTOGRAPHY MEASUREMENT (SWM)	N/A	N/A	Applicable	SHEAR WAVE ELASTOGRAPHY MEASUREMENT

The acceptance criteria for substantial equivalence are implied through the comparison: the subject device must demonstrate equivalent intended use, technological characteristics, safety, and effectiveness to its predicate devices. The document asserts that "The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging and fluid flow analysis" and "The subject and predicate device(s) have the same gray scale and Doppler capabilities."

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

The document explicitly states: "Clinical testing: None required". This indicates that no clinical "test set" in the sense of patient data was used to prove performance against acceptance criteria for this 510(k) submission. The submission relies on non-clinical testing and substantial equivalence to predicate devices already on the market.

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)

Since no clinical testing was performed for this submission, there is no information provided regarding experts establishing ground truth for a test set.

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

As no clinical testing was performed, there is no adjudication method described for a test set.

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

The document does not mention any MRMC comparative effectiveness studies or any AI assistance. The device in question is an ultrasound imaging system, not an AI-based diagnostic tool.

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

This pertains to AI-based algorithms. The document does not describe the device as an AI-based algorithm, but rather an ultrasound imaging system. Therefore, no standalone algorithm performance study was reported.

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

Since no clinical testing data was reported as part of this submission, no type of ground truth for a test set is specified.

8. The sample size for the training set

This is relevant for machine learning models. The document does not indicate the use of such models or discuss a training set.

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

As no training set is discussed, the method for establishing its ground truth is not mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and three human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 21, 2016

Hitachi Aloka Medical America, Inc. % Ms. Angela Van Arsdale RA/QA Manager 10 Fairfield Blvd. WALLINGFORD CT 06492

Re: K153421

Trade/Device Name: HI VISION Ascendus Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: December 10, 2015 Received: December 11, 2015

Dear Ms. Van Arsdale:

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.

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.

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.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K153421

Device Name HI VISION Ascendus

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
----------------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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HI VISION Ascendus System:

Transducer: All connectable probes

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
General(Track 1 only)	Ophthalmic
Ophthalmic	Fetal	P	P	P	P	P	P	P
	Abdominal	Pa	Pa	Pa	Pa	Pa	Pa	Pa
	Intra-operative (Spec.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic	P	P	P		P	P	P
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd	Pc	Pd	Pd	Pd
	Neonatal Cephalic	P	P	P	P	P	P	P
Fetal Imaging &Other	Adult Cephalic	P	P	P	P	P	P	P
	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (Spec.)
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (Card.)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Other (Spec.)

Peripheral Vessel	Peripheral Vessel	P	P	P	P	P	P	P
	Other (Spec.)
N= new indication P= previously cleared in K110673
*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW,TDI-B/B, TDI-B/M, TDI-B/PW, TDI-PW/PW
**Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, 4D Imaging, Omni Directional M mode, Wide View, Real Time Biplane,Contrast Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography, Shear Wave Measurement.
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy.
Subscript "f": Includes managing for guidance of trans-vaginal biopsy.

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: __

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System: HI VISION Ascendus

Transducer: EUP-B512

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General(Track 1 only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW

	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Contrast Imaging, Real Time Virtual Sonography.


Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{5}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-B514

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*(Spec.)	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Virtual Sonography.


Additional Comments:

Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{6}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-B712

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	* Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW

	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Contrast Imaging, Real Time Virtual Sonography.


Additional Comments:
Subscript "a":Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{7}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-B715

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW

	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Contrast Imaging, Real Time Virtual Sonography.


Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{8}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-C511

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult	P	P	P		P	P	P
Cardiac	Cardiac Pediatric	P	P	P		P	P	P
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel	P	P	P		P	P	P
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	* Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/CFM-B/PW

	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane,
	Contrast Imaging, Real Time Virtual Sonography.

Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{9}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-C514

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW

	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane,
	Contrast Imaging, Real Time Virtual Sonography.

Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{10}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-C524

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pc	Pc	Pc		Pc	Pc	Pc
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	* Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW

	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane,


Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{11}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-C532

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General(Track 1 only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
Fetal Imaging &Other	Intra-operative (Spec.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic	P	P	P		P	P	P
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel	P	P	P		P	P	P
	Other (Spec.)
N= new indication P= previously cleared in K110673
*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW
**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Real Time Tissue Elastography, Real Time Virtual Sonography.
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy.
Subscript "f": Includes managing for guidance of trans-vaginal biopsy.
Subscript "g": For Adults and Pediatric patients

Prescription Use Only (per 21 CFR 801.109)

(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)

{12}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-C715

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	* Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW

	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane,
	Contrast Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography, Shear Wave Measurement.

Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{13}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-CC531

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW

	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Real Time Biplane,
	Contrast Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography,

Additional Comments:
Subscript "a":Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{14}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-CC531S

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
(Track 1 only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	* Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/CFM-B/PW

	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Real Time Biplane,
	Contrast Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography.

Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ________________

{15}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-CV524

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General(Track 1 only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	P	P	P		P	P	P
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW

	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging, Omni Directional M mode


Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: __

{16}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-CV714

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General(Track 1 only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	P	P	P		P	P	P
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.

	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging, Omni Directional M mode.
Additional Comments:


Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{17}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-CV724

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General(Track 1 only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	P	P	P		P	P	P
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.

	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging, Omni Directional M mode.


Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: _______________

{18}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-ES52E

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)	P	P	P	P	P	P	P
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.

	**Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode.


Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ________________

{19}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-ES52M

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
General(Track 1 only)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Card.)	P	P	P	P	P	P	P
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673
	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.
	**Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode.
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{20}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-F334

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

CombinedGeneralSpecificColorOther * (Spec.)BMPWDCWD(Track 1 only)(Tracks I & III)Doppler(Spec.)OphthalmicOphthalmicFetalAbdominalPbPbPbPbPbPbIntra-operative (Spec.)Intra-operative (Neuro.)LaparoscopicPPPPbPPediatricPcРсРсРсРсРсSmall Organ (Spec.)PPPPbNeonatal CephalicbFetal Imaging &Adult CephalicOtherPPPPPPTrans-rectalPPPPPPTrans-vaginalTrans-urethralTrans-esoph. (non-Card.)Musculo-skel. (Convent.)Musculo-skel. (Superfic.)Intra-luminalOther (Spec.)Cardiac AdultCardiacCardiac PediatricTrans-esophageal (Card.)Other (Spec.)PPeripheral VesselPPPPPPeripheral VesselOther (Spec.)N= new indication P= previously cleared in K110673* Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane.Additional Comments:Subscript "a":Includes imaging tor guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis).Subscript "b":Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures).Subscript "c":Includes thyroid, parathyroid, breast, scrotum, penis.Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.Subscript "d":Subscript "e":Includes imaging for guidance of trans-rectal biopsy.Subscript "f":Includes managing for guidance of trans-vaginal biopsy.Subscript "g":For Adults and Pediatric patients.	Clinical Application

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ________________

{21}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-F531

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application	Specific(Tracks I & III)	B	M	PWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
General(Track 1 only)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P
	Intra-operative (Spec.)	Pb	Pb	Pb	Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P
	Small Organ (Spec.)	Pc	Pc	Pc	Pc	Pc	Pc
	Neonatal Cephalic	P	P	P	P	P	P
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal	P	P	P	P	P	P
	Trans-vaginal	P	P	P	P	P	P
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel	P	P	P	P	P	P
	Other (Spec.)
	N= new indication P= previously cleared in K110673
	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane.

Additional Comments:
Subscript "a":Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{22}------------------------------------------------

HI VISION Ascendus System:

Transducer: EUP-L52

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General(Track 1 only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel	P	P	P		P	P	P
	Other (Spec.)
	N= new indication P= previously cleared in K110673
	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.
	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane,Contrast Imaging, Real Time Tissue Elastography.
	Additional Comments:
	Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
	Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
	Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
	Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
	Subscript "e": Includes imaging for guidance of trans-rectal biopsy.
	Subscript "f": Includes managing for guidance of trans-vaginal biopsy.
	Subscript "g": For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ________________

{23}------------------------------------------------

HI VISION Ascendus System:

Transducer: EUP-L53

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*(Spec.)	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)	Other** (Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel	P	P	P		P	P	P
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	* Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.

	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Tissue Elastography


Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).Subscript "b":
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: __

{24}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-L53L

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Other** (Spec.)SpecificCombinedGeneralColorBMPWDCWD(Tracks I & III)(Track 1 only)Doppler(Spec.)OphthalmicOphthalmicFetalPPPPPPAbdominalIntra-operative (Spec.)Intra-operative (Neuro.)LaparoscopicPPPbbPPediatricSmall Organ (Spec.)РсРсРсPcPcPcNeonatal CephalicFetal Imaging &Adult CephalicOtherTrans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card.)PPPPPPMusculo-skel. (Convent.)PPPPPPMusculo-skel. (Superfic.)Intra-luminalOther (Spec.)Cardiac AdultCardiacCardiac PediatricTrans-esophageal (Card.)Other (Spec.)Peripheral VesselPPPPPeripheral VesselPbOther (Spec.)N= new indication P= previously cleared in K110673 Combination of each operating mode, B, M, PWD, and Color Dopler, B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW.**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Tissue ElastographyAdditional Comments:Subscript "a":Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis).Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures).Subscript "b":Subscript "c":Includes thyroid, parathyroid, breast, scrotum, penis.Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.Subscript "d":Subscript "e":Includes imaging for guidance of trans-rectal biopsy.Includes managing for guidance of trans-vaginal biopsy.Subscript "f":Subscript "g":For Adults and Pediatric patients.	Clinical Application

Prescription Use Only (per 21 CFR 801.109)

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)

{25}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-L54MA

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application	Specific(Tracks I & III)	B	M	PWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
General(Track 1 only)	Ophthalmic
	Fetal
	Abdominal	Pa	Pa	Pa	Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd	Pd	Pd	Pd
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P	P	P	P
	Musculo-skel. (Superfic.)	P	P	P	P	P	P
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel	P	P	P	P	P	P
	Other (Spec.)
	N= new indication P= previously cleared in K110673
	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.
	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, Real Time Tissue Elastography.
Additional Comments:
	Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
	Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
	Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
	Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
	Subscript "e": Includes imaging for guidance of trans-rectal biopsy.
	Subscript "f": Includes managing for guidance of trans-vaginal biopsy.
	Subscript "g": For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: _______________

{26}------------------------------------------------

HI VISION Ascendus System:

Transducer: EUP-L65

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General(Track 1 only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pc	Pc	Pc		Pc	Pc	Pc
Fetal Imaging &Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (Spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel	P	P	P		P	P	P
	Other (Spec.)
N= new indication P= previously cleared in K110673
*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.
**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, Real Time Tissue ElastographyReal Time Virtual Sonography.
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ________________

{27}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-L73S

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General(Track 1 only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
Fetal Imaging &Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)

Peripheral Vessel	Peripheral Vessel	P	P	P		P	P	P
	Other (Spec.)
	N= new indication P= previously cleared in K110673
	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.

	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, Contrast Imaging, Real Time TissueElastography, Real Time Virtual Sonography.
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ___

{28}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-L74M

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application	Specific(Tracks I & III)	B	M	PWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
General(Track 1 only)	Ophthalmic
Ophthalmic	Fetal
	Abdominal	Pa	Pa	Pa	Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd	Pd	Pd	Pd
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P	P	P	P
	Musculo-skel. (Superfic.)	P	P	P	P	P	P
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel	P	P	P	P	P	P
	Other (Spec.)
	N= new indication P= previously cleared in K110673
	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.
	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, Contrast Imaging, Real Time TissueElastography, Real Time Virtual Sonography.
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{29}------------------------------------------------

HI VISION Ascendus System:

Transducer: EUP-L75

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel	P	P	P		P	P
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.

	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane,
	Real Time Tissue Elastography, Real Time Virtual Sonography.

Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{30}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-LV74

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General(Track 1 only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pc	Pc	Pc		Pc	Pc	Pc
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)

Peripheral Vessel	Peripheral Vessel	P	P	P		P	P	P
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.


	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging, Omni Directional M mode, Real Time Tissue Elastography

Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{31}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-053T

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	* Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.

	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Contrast Imaging, Real Time Tissue Elastography.


Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{32}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-054J

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application	Specific(Tracks I & III)	B	M	PWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
General(Track 1 only)	Ophthalmic
Ophthalmic	Fetal
	Abdominal
	Intra-operative (Spec.)	Pb	Pb	Pb	Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P	P	P	P
	Musculo-skel. (Superfic.)	P	P	P	P	P	P
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)

Peripheral Vessel	Peripheral Vessel	P	P	P	P	P	P
	Other (Spec.)
	N= new indication P= previously cleared in K110673
	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.
	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, Real Time Tissue Elastography.
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ________________

{33}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-0732T

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General(Track 1 only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)	P	P	P		P	P	P
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.

	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane,
	Contrast Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography.

Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{34}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-OL334

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General(Track 1 only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic	P	P	P		P	P	P
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.

	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Contrast Imaging, Real Time Tissue Elastography.


Additional Comments:
Subscript "a":Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{35}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-R54AW-19, -33

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application		B	M	PWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
General(Track 1 only)	Specific(Tracks I & III)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	P
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.

	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Real Time Tissue Elastography.


Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{36}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-S50A

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P
	Abdominal	Pa	Pa	Pa	Pa	Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic	P	P	P	P	P	P	P
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel	P	P	P	P	P	P	P
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	* Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW,		TDI-B/B, TDI-B/M, TDI-B/PW, TDI-PW/PW.

	** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode, Contrast Imaging.


Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{37}------------------------------------------------

HI VISION Ascendus System:

Transducer: EUP-S52

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)	Pc	Pc	Pc	Pc	Pc	Pc	Pc
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	* Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW,
			TDI-B/B, TDI-B/M, TDI-B/PW, TDI-PW/PW

	** Amplitude Doppler (Color Flow Angiography), Tisue Doppler Imaging, Omni Directional M mode, Real Time Biplane.

Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: _______________

{38}------------------------------------------------

HI VISION Ascendus System:

Transducer: EUP-S70

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic	P	P	P	P	P	P	P
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel	P	P	P	P	P	P	P
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	* Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW,
	TDI-B/B, TDI-B/M, TDI-B/PW, TDI-PW/PW
	** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode, Real Time Biplane, Contrast Imaging.


Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ________________

{39}------------------------------------------------

HI VISION Ascendus System:

Transducer: EUP-S72

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)
	Neonatal Cephalic	P	P	P	P	P	P	P
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW,
	TDI-B/B, TDI-B/M, TDI-B/PW, TDI-PW/PW
	**Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane.


Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: _______________

{40}------------------------------------------------

HI VISION Ascendus System:

Transducer: EUP-S80

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
General(Track 1 only)	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P	P	P	P	P
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
Cardiac	Cardiac Adult	P	P	P	P	P	P	P
	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel	P	P	P	P	P	P	P
	Other (Spec.)
	N= new indication P= previously cleared in K110673
	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW,TDI-B/B, TDI-B/M, TDI-B/PW, TDI-PW/PW
	**Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode, Real Time Biplane, Contrast Imaging.
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: _______________

{41}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-U533

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	* Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.

	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Real Time Tissue Elastography, Real Time Virtual Sonography,


Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{42}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-V53W

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	* Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Contrast Imaging, Real Time Tissue Elastography,
		Real Time Virtual Sonography.


Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{43}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-V73W

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application
General	Specific					Color	Combined*	Other** (Spec.)
(Track 1 only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673

	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.

	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane,Contrast Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography.


Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":	For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

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System: HI VISION Ascendus

Transducer: EUP-VV531

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical Application	Specific(Tracks I & III)	B	M	PWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
General(Track 1 only)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal	P	P	P	P	P	P
	Trans-vaginal	P	P	P	P	P	P
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)
	N= new indication P= previously cleared in K110673
	*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.
	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging.
	Additional Comments:
	Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
	Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
	Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
	Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
	Subscript "e": Includes imaging for guidance of trans-rectal biopsy.
	Subscript "f": Includes managing for guidance of trans-vaginal biopsy.
	Subscript "g": For Adults and Pediatric patients.

Prescription Use Only (per 21 CFR 801.109)

(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)

{45}------------------------------------------------

System: HI VISION Ascendus

Transducer: EUP-VV731

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

Clinical ApplicationGeneral(Track 1 only)	Specific(Tracks I & III)	B	M	PWD	ColorDoppler	Combined*(Spec.)	Other** (Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P
Fetal Imaging &Other	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	P
	Trans-vaginal	P	P	P	P	P	P
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Card.)
	Other (Spec.)
Peripheral Vessel	Peripheral Vessel
	Other (Spec.)

N= new indication P= previously cleared in K110673
*Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.
**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging.
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy.
Subscript "f": Includes managing for guidance of trans-vaginal biopsy.
Subscript "g": For Adults and Pediatric patients

Prescription Use Only (per 21 CFR 801.109)

(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)

{46}------------------------------------------------

510(k) Summary of Safety and Effectiveness in accordance with 21 CFR Part 807, Subpart E, Section 807.92.

21 CFR 807.92, Subsection a

1. Submitter's Information

Hitachi Aloka Medical America, Inc. 10 Fairfield Boulevard Wallingford, CT 06492-5903 On behalf of HITACHI MEDICAL CORPORATION 4-14-1, Soto-Kanda, Chivoda-Ku, Tokyo, JAPAN

Primary Contact Person: Angela Van Arsdale R.A. / O.A. Manager Telephone: (203) 269-5088 Ext: 346 Fax Number: (203) 269-6075

Secondary Contact Person: Lisa DelMonte Regulatory Affairs Product Specialist Telephone: (203) 269-5088 Ext: 348 Fax Number: (203) 269-6075

Date Prepared: November 23, 2015

Device / Common / Classification Name / Classification / Product Code:

Device Proprietary Name - HI VISION Ascendus Common name - Diagnostic Ultrasound System and Transducers Classification name - System, Imaging, Pulsed Doppler, Ultrasonic Classification: Class II 90-IYN 892.1550 Ultrasonic Pulsed Imaging System Product Code: 90-IYO 892.1560 Ultrasonic Pulsed Echo Imaging System 90-ITX 892.1570 Diagnostic Ultrasound Transducer

1. Legally Marketed Predicate Device(s):
  HI VISION Ascendus (K110673) Noblus (K142368) Siemens Acuson S2000/S3000 (K130881)

4. Device Description:

An ultrasound diagnostic system with the following features:

Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes O
O Ultrasound transducer accessories (standard and optional) - to maximize functional usage of transducer(s) in various modes of operation
O A computer system - to control the transducer and analyze the signals resulting from the reflected echoes
o A video monitor with optional image recorder - to display the computed image or derived Doppler data

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5. Indication for Use:

HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac) -Adult/Pediatric, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.

The modes of operation of the HI VISION Ascendus are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Dual Doppler mode, CFI mode (Color Flow Image), Amplitude Dopper (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real-time Virtual Sonography, Realtime Tissue Elastography and Shear Wave Measurement.

6. Comparison to predicate device:

The Hitachi HI VISION Ascendus Ultrasound Electronic Scanner is equivalent to the predicate devices the Hitachi HI VISION Ascendus (K110673). The HI VISION Ascendus has been modified to include features from both the Noblus (K142368) and Siemens S2000/S3000( K130881). The subject and predicate devices are Track III systems.

	Predicate Device	Predicate Device	Predicate Device	Subject Device
	HI VISION ASCENDUS	Noblus	Siemens ACUSON	HI VISION ASCENDUS
	(K110673)	(K142368)	S2000/S3000 (K130881)
Intended Use:	Intended for use for Fetal,Abdominal, Intr-operative(Spec.), Intra-operative(Neuro.), Laparoscopic,Pediatric, Small Organ(Spec.), Neonatal Cephalic,Adult Cephalic, Trans-rectal, Trans-Vaginal,Musculo-skel. (Convent.),Musculol-skel. (Superfic.),Cardiac Adult, CardiacPediatric, Trans-esophageal(card.), Peripheral vessel.The modes of operation areB mode, M mode, PWD(Pulsed Wave Doppler)mode, CWD (ContinuousWave Doppler) mode,Color Doppler, AmplitudeDoppler, HarmonicImaging, Superficialmusculoskeletal imaging,and 3D Imaging	Intended for use by trainedpersonnel (doctor,sonographer, etx.) for thediagnostic ultrasoundevaluation of Abdominal,Cardiac, Intra-operative,Fetal, Pediatric, SmallOrgan, Peripheral vessel,Biopsy, Trans-rectal, Trans-vaginal, Neonatal Cephalic,Adult Cephalic, Intra-luminal, Gynecology,Urology and Laparoscopicclinical applications.The main features onNoblus are B mode, Mmode, PW mode (PulsedWave Doppler), CW mode(Continuous WaveDoppler), CFI mode (ColorFlow Image), TDI (TissueDoppler Imaging) and Real-time Tissue Elastography	Iintended for the followingapplications: Fetal,Abdominal,Intraoperative, Pediatric,Small Parts, Transcranial,OB/GYN, Cardiac, Pelvic,Neonatal/Adult Cephalic,Vascular,Musculoskeletal,SuperficialMusculoskeletal, andPeripheral Vascularapplications.	Intended for use for Fetal,Abdominal, Intr-operative(Spec.), Laparoscopic,Pediatric, Small Organ(Spec.), Neonatal Cephalic,Adult Cephalic, Trans-rectal, Trans-Vaginal,Musculo-skel. (Convent.),Musculol-skel. (Superfic.),Cardiac Adult, CardiacPediatric, Trans-esophageal (card.),Peripheral vessel.The modes of operation areB mode, M mode, PWD(Pulsed Wave Doppler)mode, CWD (ContinuousWave Doppler) mode,Color Doppler, AmplitudeDoppler, HarmonicImaging, Superficialmusculoskeletal imaging,and 3D Imaging.
FDA Track:	3	3	3	3
*Probes:	Convex, Linear, Sector, 4D,Other	Convex, Linear, Sector, 4D,Other, EUS	Convex, Linear, Sector,Other	Convex, Linear, Sector,4D, Other
Display Modes:	Combinations ofB, M, PW, CW	Combinations ofB, M, PW, CW	Unknown	Combinations ofB, M, PW, CW
Real-time TissueElastography(RTTE) withSTRAINRATIO/STRAINHISTOGRAM*	RTTE only	Real-time TissueElastography (RTTE) withSTRAIN RATIO/STRAINHISTOGRAM	Applicable	Real-time TissueElastography (RTTE) withSTRAIN RATIO/STRAINHISTOGRAM
SHEAR WAVEELASTOGRAPHYMEASUREMENT(SWM)*	N/A	N?A	Applicable	SHEAR WAVEELASTOGRAPHYMEASUREMENT

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21 CFR Part 807.92, Section b

1. Non-clinical Testing
  No new hazards were identified with the subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.
1. Clinical testing:
  None required
1. Conclusions:
  The HI VISION Ascendus Diagnostic Ultrasound scanner is substantially equivalent in safety and effectiveness to the predicate device(s);
. The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging and fluid flow analysis.
. The subject and predicate device(s) have the same gray scale and Doppler capabilities.
The subject and predicate device(s) have the same essential technology for imaging, Doppler functions, and signal processing.
. The subject and predicate device(s) have acoustic level below the Track 3 FDA limits.
트 The subject and predicate device(s) are manufactured in accordance to FDA 21 CFR 820 Quality System Regulations.
. The subject and predicate device(s) are designed and manufactured to the same electrical and physical safety standards.
. The subject and predicate device(s) are manufactured with materials that have been tested in accordance to ISO 10993-1; all biocompatibility testing has been conducted in accordance to each component material characterization, type of body contact, and duration contact risk profile.
. The subject and predicate device(s) are designed to be re-usable and provide instructions for cleaning. disinfection, and sterilization in the Ultrasound system and transducer manuals.

END OF SUMMARY

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.