The Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative (Spec.), Trans-esophageal (Cardiac, Non-Cardiac) - Adult/Pediatric, Wound (Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biospy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intraluminal, Gynecology, Urology, and Laparoscopic clinical applications.

The modes of operation of the Hitachi Noblus™ Ultrasound Diagnostic System are B mode, M mode, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging and Real Time Tissue Elastography.

Device Description

An ultrasound diagnostic system with the following features:

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

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Hitachi Noblus™ Ultrasound Diagnostic System. This document asserts the substantial equivalence of the Noblus™ to legally marketed predicate devices, rather than detailing a specific study to prove acceptance criteria for novel functionalities.

Therefore, the acceptance criteria and details of a proving study as typically applied to new or significantly modified aspects requiring such validation are not fully present in the provided text. The document instead focuses on demonstrating that the new combined features and transducers of the Noblus™ are substantially equivalent to existing cleared devices, implying that the acceptance criteria for those existing devices are met.

However, I can extract the relevant information regarding the device's claimed performance based on its stated equivalence and the non-clinical testing performed.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission asserting substantial equivalence, formal acceptance criteria as a quantitative threshold for novel performance claims are not explicitly stated for new features. Instead, the "acceptance criteria" here implicitly refer to the device performing comparably to the predicate devices for their respective indications. The "reported device performance" is essentially that it functions in the specified modes and applications similar to the already cleared predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance (Claimed Substantial Equivalence)
Diagnostic Ultrasound System functionality (general imaging, Doppler, signal processing) for indicated clinical applications.	The Noblus™ has the "same gray scale and Doppler capabilities" and "same essential technology for imaging, Doppler functions, and signal processing" as the predicate K130308. It is intended for a broad range of diagnostic ultrasound evaluations (Abdominal, Cardiac, Fetal, Small Organ, etc.).
Acoustic output within FDA limits.	Acoustic level is "below the Track 3 FDA limits."
Biocompatibility of materials.	Manufactured with materials "tested in accordance to ISO 10993-1" and all biocompatibility testing "conducted in accordance to each component material characterization, type of body contact, and duration contact risk profile."
Electrical and mechanical safety standards compliance.	Designed and manufactured to "the same electrical and physical safety standards."
Cleaning and disinfection effectiveness for re-usable components.	Designed to be re-usable and "provide instructions for cleaning, disinfection, and sterilization in the Ultrasound system and transducer manuals."
Effective wound scanning capabilities.	Capable of scanning wounds "in the same manner as the predicate Hudson 2020/2040/2060 scanner [K022928]" without additional risk.
Effective free-hand scanning for 3D visualization.	Employs free-hand scanning for 3D visualization "the same as the Hitachi HI VISION ASCENDUS Diagnostic Ultrasound Scanner cleared via K110673."
Effective Real Time Tissue Elastography (RTTE) with Strain Ratio for tissue characterization comparable to predicate elastography features.	The RTTE feature incorporates a Strain Ratio, which is "substantially equivalent to the Siemen Acuson S2000 [K130881] Supersonic Image Shearwave Elastography feature." It provides a color graph of tissue strain to assist in visualization and perimeter of a tumor, lump or mass, without additional risk.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states "Non-clinical Testing" and "Clinical testing: None required." This indicates that no new clinical test set with a specific sample size was collected or analyzed for the purpose of this specific 510(k) submission to prove the device meets acceptance criteria for novel claims. The primary basis for equivalence is comparison to previously cleared devices. If any non-clinical testing involved datasets (e.g., for algorithm validation if there were any, which isn't explicitly detailed as a novel algorithm here), the details are not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Given that "Clinical testing: None required" and the submission relies on substantial equivalence to existing devices, there is no mention of a new test set requiring new ground truth established by experts specifically for this submission. The ground truth for the predicate devices would have been established during their respective clearance processes.

4. Adjudication Method for the Test Set:

Not applicable, as no new clinical test set (with specific ground truth requiring adjudication) was explicitly described for this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study is not mentioned as having been done for this submission. The submission is based on substantial equivalence, comparing the device to existing cleared devices rather than assessing performance improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The document describes an ultrasound system with various imaging modes and features, including "Real Time Tissue Elastography" with a "strain ratio feature." While Elastography involves algorithms, the submission doesn't detail a standalone algorithmic performance study independent of human interpretation. The claim is that the feature itself is substantially equivalent to a predicate device's feature, implying that its standalone performance would be comparable, but no specific study is described.

7. The Type of Ground Truth Used:

For the features deemed substantially equivalent to predicate devices, the presumed "ground truth" would have been established during the clearance of those predicate devices. This could include various types of clinical data, expert consensus, and in some cases, pathology or outcome data, depending on the specific application addressed by each predicate. For the Real Time Tissue Elastography, the comparison is functionally qualitative ("provides color graph of tissue strain... to assist in visualization and perimeter of a tumor, lump or mass in liver, breast, thyroid, etc. for biopsy purposes") rather than being tied to definitive pathology for this specific submission's evaluation.

8. The Sample Size for the Training Set:

Not applicable. This is a 510(k) demonstrating substantial equivalence for an ultrasound system, not a submission for a de novo AI/ML algorithm that would undergo specific training and validation studies with disclosed training set sizes. The "training" for the device's various imaging modes is inherent in its engineering and design based on established ultrasound physics and technologies, and comparison to predicate devices, not typically in the sense of an AI/ML training dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there's no mention of an AI/ML training set in the context of this 510(k) summary. The development of the Noblus™ system relies on established medical device development practices and comparisons to already cleared technologies.

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 features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

January 14, 2015

Hitachi Aloka Medical, Ltd. % Ms. Angela Van Arsdale Regulatory Affairs /Ouality Assurance Manager 10 Fairfield Blvd. WALLINGFORD CT 06492

Re: K142368

Trade/Device Name: Noblus™ Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: December 29, 2014 Received: December 30, 2014

Dear Ms. Van Arsdale:

EG-3270UK

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Transducer Model Number
C22K	C22P	C25	C251	C35
C41	C41B	C41L47RP	C41V	C41V1
C42	C42K	CC41R	EUP-B512	EUP-B715
EUP-C715	EUP-CC531S	EUP-L53L	EUP-L74M	EUP-O53T
EUP-O54J	EUP-O732T	EUP-OL334	L34	L44
L441	L55	L64	R41R	S21
S211	S31	VC34A	UST-2265-2	EB-1970UK

EG-3870UTK

S3ESS / S3ESL

EG-3670URK

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

EUP-R54AW-19 / EUP-R54AW-33

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 mav publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Robert A Ochs

Robert Ochs, Ph.D. Acting 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) K142368

Device Name Noblus TM Ultrasound Diagnostic System

Indications for Use (Describe)

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

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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System: Noblus

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
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		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.)	Ng	Ng	Ng	Ng	Ng	Ng	Ng
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.) - Wound	Nh	Nh	Nh		Nh	Nh	Nh
	Other (spec.) - Gynecologic	P	P	P		P	P	P
	Endoscopy	P	P	P		P	P	P
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (card.)	Ng	Ng	Ng	Ng	Ng	Ng	Ng
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.)
N = new indication. P = previously cleared in K130308Combination of each operating mode, B, M, PWD, CWD and Color Doppler.*Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, 4D 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. For Adult and Pediatric patients.

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy. Subscript "g":

Subscript "h": Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 2 of 42

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Noblus System:

C22K Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I 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.)	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.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
N = new indication. P = previously cleared in K130308
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), 3D 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 imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and Pediatric patients. Subscript "h": Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 3 of 42

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System:	Noblus
Transducer:	C22P

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application	Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	Color Doppler	Combined*(Spec.)	Other**(Spec.)
	Ophthalmic	P	P	P		P	P	P
	Fetal
	AbdominalIntra-operative (Spec.)	Pa	Pa	Pa		Pa	Pa	Pa
	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.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in K134016 & K140443

*Combination of each operating mode, B, M, PWD, and Color Doppler.

**Amplitude Doppler (Color Flow Angiography), 3D 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 4 of 42

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System: Noblus

C25 Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I 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	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.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in K130308

*Combination of each operating mode, B, M, PWD and Color Doppler.

**Amplitude Doppler (Color Flow Angiography), 3D Imaging

Additional Comments:

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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 5 of 42

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Noblus System:

C251 Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

SpecificPWDCWDCombinedOtherGeneralBMColor(Track I only)Doppler(Tracks I & III)(Spec.)(Spec.)OphthalmicOphthalmicFetalPPPPPPAbdominalPaPaPaPaPaPaIntra-operative (Spec.)Intra-operative (Neuro.)LaparoscopicPPPPPPPediatricSmall Organ (Spec.)PdPdPdPdPdPdNeonatal CephalicAdult CephalicFetal Imaging& OtherTrans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card.)Musculo-skel. (Convent.)Musculo-skel. (Superfic.)Intra-luminalOther (spec.) - WoundCardiac AdultCardiac PediatricCardiacTrans-esophageal (card.)Other (spec.)PeripheralPeripheral vesselVesselOther (spec.)N = new indication. P = previously cleared in K134016 & K140443Combination of each operating mode, B, M, PWD and Color Doppler.	Clinical Application		Mode of Operation




























** Amplitude Doppler (Color Flow Angiography), 3D Imaging
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.
Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.Subscript "d":Subcorint "all.Includes imaging for midance of trans ractal hioney.

Includes imaging for guidance of trans-rectal biopsy. Subscript "e"

Subscript "f": Includes imaging for guidance of trans-vaginal biopsy. For Adult and Pediatric patients.

Subscript "g": Subscript "h": Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 6 of 42

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System: Noblus

Transducer: C35

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I 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	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.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
N = new indication. P = previously cleared in K134016
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), 3D 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 7 of 42

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System: Noblus

Transducer: C41

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(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
	Small Organ (Spec.)	Pc	Pc	Pc		Рс	Рс	Рс
	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.)
	Intra-luminal
	Other (spec.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (spec.)
N = new indication. P = previously cleared in K130308 & K134016

*Combination of each operating mode, B, M, PWD and Color Doppler.

** Amplitude Doppler (Color Flow Angiography), 3D 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 8 of 42

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

System: Noblus

C41B Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal	Ne	Ne	Ne	Ne	Ne	Ne	Ne
	Trans-vaginal	Nf	Nf	Nf	Nf	Nf	Nf	Nf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
N = new see Appendix 1. P = previously cleared in K130308*Combination of each operating mode, B, M, PWD and Color Doppler.

** 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 9 of 42

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

System: Noblus

Transducer: C41L47RP

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	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.) - Wound
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
N = new indication. P = previously cleared in K134016 & K140443

Combination of each operating mode, B, M, PWD, CWD and Color Doppler.

** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 4D 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

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

Page 10 of 42

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

System: Noblus

Transducer: C41V

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(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& Other	Adult Cephalic
	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.) - Gynecological	P	P	P		P	P	P
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
	N = new indication. P = previously cleared in K130308
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Real Time Tissue Elastography
Additional Comments:
Includes imaging for guidance of percutaneous biopsies of abdominal organs and structures (including amniocentesis)

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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 11 of 42

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

System: Noblus

Transducer: C41V1

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(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& Other	Adult Cephalic
	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.) - Gynecological	P	P	P		P	P	P
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
N = new indication. P = previously cleared in K134016 & K140443Combination of each operating mode, B, M, PWD and Color Doppler.*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 imaging for guidance of trans-vaginal biopsy.

Subscript "h": Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 12 of 42

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

System: Noblus

C42 Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical ApplicationMode of Operation
General	Specific	B	M	PWD	CWD	Color	Combined*	Other**
(Track I only)	(Tracks I & III)					Doppler	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	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	b
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.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P		P	P	p
Vessel	Other (spec.)
	N = new indication. P = previously cleared in K130308
	*Combination of each operating mode, B, M, PWD and Color Doppler.

	** 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 imaging for guidance of trans-vaginal biopsy.

Prescription Use Only (per 21 CFR 801.109)

For Adult and Pediatric patients.

Includes imaging for Cavernous/Non-Cavernous wounds.

Subscript "g":

Subscript "h":

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 13 of 42

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

System: Noblus

C42K Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	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.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
	N = new indication. P = previously cleared in K130308 & K134016
	*Combination of each operating mode, B, M, PWD and Color Doppler.
	** Amplitude Doppler (Color Flow Angiography), 3D 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 laparosopic 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 14 of 42

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

System: Noblus

Transducer: CC41R

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(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& Other	Adult Cephalic
	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.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

	N = new indication. P = previously cleared in K134016 & K140443
	*Combination of each operating mode, B, M, PWD and Color Doppler.
	** 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 imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and Pediatric patients.

Subscript "h": Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 15 of 42

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

System: Noblus

Transducer: EUP-B512

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application	Mode of Operation
General(Track I 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.) - Wound
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
	N = new indication. P = previously cleared in K093466, K102901 & K110673
	*Combination of each operating mode, B, M, PWD, and Color Doppler.
	**Amplitude Doppler (Color Flow Angiography), 3D 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 imaging for guidance of trans-vaginal biopsy.

Prescription Use Only (per 21 CFR 801.109)

For Adult and Pediatric patients.

Includes imaging for Cavernous/Non-Cavernous wounds.

Subscript "g":

Subscript "h":

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

Page 16 of 42

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

System: Noblus

EUP-B715 Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application				Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
(Track I only)	(Tracks I & III)
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.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
	N = new indication. P = previously cleared in K110673
	*Combination of each operating mode, B, M, PWD and Color Doppler.
	** Amplitude Doppler (Color Flow Angiography), 3D 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 17 of 42

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

System: Noblus

Transducer: EUP-C715

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I 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	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.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
	N = new indication. P = previously cleared in K093466, K102901 & K110673
	*Combination of each operating mode, B, M, PWD and Color Doppler.
	**Amplitude Doppler (Color Flow Angiography), 3D 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 imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and Pediatric patients.

Subscript "h": Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 18 of 42

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

System: Noblus

EUP-CC531S Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
		B	M	PWD	CWD	Color Doppler	Combined*(Spec.)	Other**(Spec.)
General(Track I only)	Specific(Tracks I & III)
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	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.) - Wound
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

Additional Comments:

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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 19 of 42

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

System: Noblus

Transducer: EUP-L53L

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application					Mode of Operation
General(Track I 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.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)

PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)
	N = new indication. P = previously cleared in K093466, K102901 & K110673
	*Combination of each operating mode, B, M, PWD, and Color Doppler.
	** 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 imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and Pediatric patients.

Includes imaging for Cavernous/Non-Cavernous wounds. Subscript "h":

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 20 of 42

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

System: Noblus

Transducer: EUP-L74M

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application	Mode of Operation
General(Track I 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.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)
	N = new indication. P = previously cleared in K093466, K102901 & K110673
	*Combination of each operating mode, B, M, PWD, and Color Doppler.
	**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.

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 imaging for guidance of trans-vaginal biopsy.

Subscript "f": Subscript "g": For Adult and Pediatric patients.

Subscript "h": Includes imaging for Cavernous/Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 21 of 42

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

System: Noblus

Transducer: EUP-053T

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

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

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 imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and Pediatric patients. Subscript "h": Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 22 of 42

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

System:	Noblus
Transducer:	EUP-054J
	Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other*(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& 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.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)
	N = new indication. P = previously cleared in K130308

	*Combination of each operating mode, B, M, PWD and Color Doppler.
	**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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous / Non-Cavernous wounds.
Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(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& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
	N = new indication. P = previously cleared in K110673
*Combination of each operating mode, B, M, PWD and Color Doppler.
**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).

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 23 of 42

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

System: Noblus

Transducer: EUP-0732T

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

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 imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and Pediatric patients. Subscript "h": Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 24 of 42

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

System: Noblus

EUP-OL334 Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I 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.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)
N = new indication. P = previously cleared in K130308
*Combination of each operating mode, B, M, PWD and Color Doppler.
**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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous / Non-Cavernous wounds

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 25 of 42

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

System:

EUP-R54AW-19 / EUP-R54AW-33 Transducer:

Noblus

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
		General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	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.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 26 of 42

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

System: Noblus

Transducer: L34

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I 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.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)

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

Additional Comments:

Additional Conditions:
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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 27 of 42

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

System: Noblus

Transducer: L44

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I 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.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)
	N = new indication. P = previously cleared in K130308

*Combination of each operating mode, B, M, PWD, and Color Doppler.

** 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 28 of 42

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

System: Noblus

Transducer: L441

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I 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		bd	Pd	Pd
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	b		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	b		P	P	P
Vessel	Other (spec.)
	N = new indication. P = previously cleared in K134016 & K140443

*Combination of each operating mode, B, M, PWD and Color Doppler.

** Amplitude Doppler (Color Flow Angiography), Tissue Doppler 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 29 of 42

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

System:	Noblus
Transducer:	L55
	Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I 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.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.) - Wound	Nh	Nh	Nh		Nh	Nh	Nh
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (spec.)
	N = new indication. P = previously cleared in K130308
	*Combination of each operating mode, B, M, PWD and Color Doppler.
	**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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.

(Division Sign – Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

510(k) Number:_

Page 30 of 42

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

System: Noblus

Transducer: L64

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I 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.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.) - Wound	Nh	Nh	Nh		Nh	Nh	Nh
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)
	N = new indication. P = previously cleared in K130308

*Combination of each operating mode, B, M, PWD and Color Doppler.

** 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Page 31 of 42

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

System: Noblus

Transducer: R41R

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application	Mode of Operation
General	Specific	B	M	PWD	CWD	Color	Combined*(Spec.)	Other**(Spec.)
(Track I only)	(Tracks I & III)					Doppler
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	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.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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 imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and Pediatric patients. Subscript "h": Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

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Page 32 of 42

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System:	Noblus
Transducer:	S21
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Clinical Application	Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(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& Other	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.) - Wound
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.)

N = new indication. P = previously cleared in K130308

*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.

**Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D 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 imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and Pediatric patients.

Subscript "h": Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

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Page 33 of 42

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System: Noblus

Transducer: S211

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(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& Other	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.) - Wound
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.)

Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

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Page 34 of 42

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System: Noblus

Transducer: S31

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(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& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
Cardiac	Cardiac Adult	P	P	P	P	P	P	P
	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

Additional Comments:

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 imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and Pediatric patients.
Subscript "h": Includes imaging for Cavernous / Non-Cavernous wounds

Prescription Use Only (per 21 CFR 801.109)

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Page 35 of 42

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System: Noblus

S3ESS / S3ESL Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I 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
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)	Ng	Ng	Ng	Ng	Ng	Ng	Ng
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)	Ng	Ng	Ng	Ng	Ng	Ng	Ng
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
N = new indication. P = previously cleared
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D 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 imaging for guidance of trans-vaginal biopsy.

Subscript "g": For Adult and Pediatric patients.

Subscript "h": Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

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Page 36 of 42

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System: Noblus

VC34A Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I 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	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.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
N = new indication. P = previously cleared in K130308

Combination of each operating mode, B, M, PWD and Color Doppler.

** Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging

Additional Comments:

Additional Conditions:
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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

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Page 37 of 42

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System: Noblus

UST-2265-2 Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	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.) - Wound
	Cardiac Adult				P
Cardiac	Cardiac Pediatric				P
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel				P
	Other (spec.)
N = new indication. P = previously cleared in K033311, K032875, K040719, K122537, K134016, K140443 & K140639
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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

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Page 38 of 42

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System: Noblus

EB-1970UK Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I 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
	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.) - Wound
	Endoscopy	P	P	P		P	P	P
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
	N = new indication. P = previously cleared in K131946 & K130308

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 laparosopic 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

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Page 39 of 42

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System: Noblus

EG-3270UK Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
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.) - Wound
	Endoscopy	P	P	P		P	P	P
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
	N = new indication. P = previously cleared in K130247 & K130308

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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

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Page 40 of 42

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System: Noblus

EG-3670URK Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined*(Spec.)	Other**(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	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.) - Wound
	Endoscopy	P	P	P		P	P	P
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)
	N = new indication. P = previously cleared in K130206 & K130308

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 imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous / Non-Cavernous wounds.

Prescription Use Only (per 21 CFR 801.109)

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Page 41 of 42

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System: Noblus

EG-3870UTK Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	Color	Combined*	Other**
(Track I only)	(Tracks I & III)					Doppler	(Spec.)	(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.) - Wound
	Endoscopy	P	P	P		P	P	P
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)
	N = new indication. P = previously cleared in K130247 & K130308

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 imaging for Cavernous / Non-Cavernous wounds.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for guidance of trans-vaginal biopsy.

Prescription Use Only (per 21 CFR 801.109)

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Page 42 of 42

{44}------------------------------------------------

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

Submitter's Information

Hitachi Aloka Medical America, Inc 10 Fairfield Boulevard Wallingford, CT 06492-5903

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

Manufacturer: Hitachi Medical Corporation 4-14-1, Soto-Kanda, Chiyoda-Ku, Tokyo, Japan

Date Prepared: August 7, 2014

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

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

3. Legally Marketed Predicate Device(s):

Hitachi Noblus™ Diagnostic Ultrasound System [K130308] HI VISION ASCENDUS Diagnostic Ultrasound Scanner [K110673] Siemens Medical Solutions USA, Inc. [K130881] Hudson 2060 Ultrasound Scanner [K022928]

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
Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in O various modes of operation
A computer system to control the transducer and analyze the signals resulting from the reflected echoes o
A standard Lithium ion computer battery to allow for system portability O
A video monitor with optional image recorder to display the computed image or derived Doppler data O

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

5. Indication for Use:

The Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative (Spec.), Trans-esophageal (Cardiac/Non-Cardiac) - Adult/Pediatric, Wound (Cavernous/Non-Cavernous),, 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 Hitachi Noblus™ Ultrasound Diagnostic System are B mode, M mode, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, and Real Time Tissue Elastography.

6. Comparison to predicate device:

The subject device Hitachi Noblus™ Diagnostic Ultrasound device is technically comparable and substantially equivalent to the predicate Hitachi Noblus™ Diagnostic Ultrasound device [K130308]. Both are track 3systems that incorporate the same fundamental and scientific technologies. The subject system has expanded indications intended use and additional transducers than the predicate system.

The Noblus™ is capable of scanning wounds in the same manner as the predicate Hudson 2020/2040/2060 scanner [K022928]. Wound scanning with the Noblus™ system does not add any additional risk while providing the same supportive evidence in medical diagnosis of disease state as the currently cleared predicate device [K022928].

The Noblus™ free-hand scanning method used for 3D visualization is the same as the Hitachi HI VISION ASCENDUS Diagnostic Ultrasound Scanner cleared via K110673.

The Noblus™ Real Time Tissue Elastography feature incorporates a strain ratio feature, which is substantially equivalent to the Siemen Acuson S2000 [K130881] Supersonic Image Shearwave Elastography feature. Both Strain Ratio and Supersonic Image Shearwave provides color graph of tissue strain (hardness of tissue) to assist in visualization and perimeter of a tumor, lump or mass in liver, breast, thyroid, etc. for biopsy purposes. The addition of strain ratio to the Noblus™ Real Time Tissue Elastography feature does not additional risk. The Elastography Strain Ratio feature provides Physicians additional empirical data that may be used in conjunction with other medical data to assist in clinical diagnosis.

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21 CFR Part 807.92, Section b

1. Non-clinical Testing

No new hazards were identified with the subject device. 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.

2. Clinical testing:

None required

3. Conclusions:

The Hitachi Aloka Medical, Ltd. Noblus™ Diagnostic Ultrasound scanner is substantially equivalent in safety and effectiveness to the predicate devices;

I The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging and fluid flow analysis.
I 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.
. 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.
I 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.
. The subject and the predicate K022928 are both safe and effective for wound scanning.
I The subject and the predicate K110673 are both safe and effective for a free-hand scanning method used for 3D visualization
. The subject device is safe and effective with the use of a fully featured Real Time Tissue Elastography (RTTE) inclusive of Strain Ratio. Strain Ratio component of the Noblus™ RTTE is equivalent to the Supersonic Image Shearwave Elastography predicate K130881.

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.