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, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, 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, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color 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 document is a 510(k) summary for the Hitachi Noblus™ Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than novel performance claims requiring extensive clinical studies with specific acceptance criteria.

The document explicitly states: "Clinical testing: None required" [Section 1.1b, Page 1]. This indicates that the device's performance was not evaluated against specific acceptance criteria in a dedicated clinical study for this 510(k) submission. Instead, substantial equivalence was demonstrated through non-clinical testing and comparison to a predicate device already cleared by the FDA.

Therefore, many of the requested details about acceptance criteria and clinical study methodology are not applicable or available in this document.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/available. This submission does not provide specific performance metrics or acceptance criteria for a new clinical study. The device's performance is implicitly accepted as equivalent to the predicate device (Hitachi HI VISION Avius Diagnostic Ultrasound Scanner [K102901]) based on technical comparisons and adherence to safety standards.

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

Not applicable/available. As no clinical testing was required or conducted for this 510(k) submission to establish acceptance criteria, there is no test set sample size or data provenance to report. The evaluation was based on non-clinical testing and comparison to a predicate device.

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

Not applicable/available. Since no new clinical testing was performed to establish performance against acceptance criteria, there was no need for experts to establish ground truth for a test set in this submission.

4. Adjudication Method for the Test Set

Not applicable/available. No clinical test set was used to assess performance against acceptance criteria.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, as explicitly stated "Clinical testing: None required." The submission focuses on demonstrating substantial equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable/available. This device is an ultrasound system with various imaging modes, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply in this context. The operational modes (B mode, PW mode, CW mode, Color Doppler, etc.) are integrated features of the ultrasound system and are inherently used with human operators.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable/available. No new clinical data requiring ground truth establishment was generated for this 510(k) submission.

8. The Sample Size for the Training Set

Not applicable/available. The Hitachi Noblus™ Diagnostic Ultrasound System is a medical imaging device, not an AI/ML model that requires a training set in the conventional sense. The "training" for such devices typically involves engineering and optimizing hardware and software components based on known physics, signal processing principles, and image quality standards, rather than specific clinical image datasets.

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

Not applicable/available. As the device is not an AI/ML model requiring a training set, the concept of establishing ground truth for a training set does not apply.

Summary of Device Substantiation:

The Hitachi Noblus™ Diagnostic Ultrasound System gained FDA clearance (K130308) by demonstrating substantial equivalence to an existing legally marketed predicate device, the Hitachi HI VISION Avius Diagnostic Ultrasound Scanner [K102901].

The substantiation was based on:

Non-clinical Testing: The device and its transducers were evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, electrical safety, and mechanical safety, conforming to applicable medical device safety standards [Section 1.1b, Page 1].
Technical Comparison: The subject device was shown to be technically comparable to the predicate device, sharing the same fundamental and scientific technologies, intended use, indications for use, gray scale and Doppler capabilities, essential technology for imaging, Doppler functions, signal processing, and acoustic levels below FDA limits [Section 1.1b, Page 1].
Quality System Compliance: Both subject and predicate devices are manufactured in accordance with FDA 21 CFR 820 Quality System Regulations and designed/manufactured to the same electrical and physical safety standards [Section 1.1b, Page 1].
Biocompatibility: Materials used were tested according to tripartite biocompatibility guidance and ISO 10993-1 [Section 1.1b, Page 1].
Cleaning and Disinfection: Instructions for cleaning, disinfection, and sterilization are provided [Section 1.1b, Page 1].

The clearance process for such a device relies on these comparisons to ensure the new device is as safe and effective as a previously cleared device, without the need for new clinical trials if substantial equivalence can be adequately demonstrated through other means.

Summary

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K 130308

APR

5 2013

Section 1.1a - 510(k) Summary in accordance with 21 CFR Part 807.92, Section a

Submitter's contact name, address, telephone/fax number, date prepared:

Angela Van Arsdale RA/QA Manager Hitachi Aloka Medical, Ltd. 10 Fairfield Blvd Wallingford CT 06492 Telephone: (203) 269-5088 Ext: 346 Fax Number: (203) 269-6075

Date Prepared: February 4, 2013

Device / Common / Classification Name:

Hitachi Noblus™ Diagnostic Ultrasound System Common name - Diagnostic Ultrasound System and Transducers Classification name - System, Imaging, Pulsed Doppler, Ultrasonic

1. Substantially Equivalent Device(s):
  Hitachi Hi VISION Avius Diagnostic Ultrasound Scanner [K102901]
1. Device Description:
  An ultrasound diagnostic system with the following features:
Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected 0 echoes
Ultrasound transducer accessories (standard and optional) to maximize functional usage of o transducer(s) in various modes of operation
A computer system to control the transducer and analyze the signals resulting from the O reflected echoes
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 O data
1. Indication for Use:

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

Comparison to predicate device:

The Hitachi Noblus™ Diagnostic Ultrasound device is technically comparable and substantially equivalent to the Hitachi HI VISION Avius Diagnostic Ultrasound Scanner [K102901]. Both systems are track 3 systems that incorporate the same fundamental and scientific technologies with the exception of the following features:

STIC (Spatio Temporal Image) which is a new feature when compared to predicate [K102901]. . The STIC feature is not new to the Hitachi Ultrasound systems; it has been previously cleared in the HI VISION Ascendus system via K110673.
. Standard Lithium ion Computer battery for use in the "portable" option
. The accessories; a Biopsy Adapter [EZU-PA7L1] and a Coupler [EZU-TEATC2] which are similar in intended use and function as the accessories for the predicate device HI VISION Avius [K102901]; has historical utilization on Hitachi Ultrasound transducers and have been previously cleared on the HI VISION Ascendus via K110673.

Both the subject device and predicate device systems have the same intended use/ indications for use.

Section 1.1b - 510(k) Summary in accordance with 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.
1. Clinical testing:
  None required
1. Conclusions:
  The Hitachi Aloka Medical, Ltd. Noblus™ Diagnostic is substantially equivalent in safety and effectiveness to the predicate device;
트 The predicate and subject devices are both indicated for diagnostic ultrasound imaging and fluid flow analysis.
. The predicate and subject devices have the same gray scale and Doppler capabilities.
. The predicate and subject devices have the same essential technology for imaging. Doppler functions, and signal processing.
. The predicate and subject devices have acoustic level below the Track 3 FDA limits.
트 The predicate and subject devices are manufactured in accordance to FDA 21 CFR 820 Quality System Requlations.
트 The predicate and subject devices are designed and manufactured to the same electrical and physical safety standards.
트 The predicate and subject devices are manufactured with materials that have been tested in accordance to tripartite biocompatibility quidance and 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 predicate and subject devices are designed to be re-usable and provide instructions for cleaning, disinfection, and sterilization in the Ultrasound system and transducer manuals.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of an eagle or bird-like figure with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

April 5, 2013

HITACHI ALOKA MEDICAL LTD c/o Angela Van Arsdale Regulatory Affairs/Quality Assurance Manager 10 Fairfield Blvd Wallingford. CT 06492

Re: K130308

Trade/Device Name: Noblus TM Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, ITX, IYO Dated: February 4, 2013 Received: February 7, 2013

Dear Angela Van Arsdale:

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

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

Transducer Model Number

C22	EUP-CC531S	L34
C25	EUP-OL334	L44
C41	EUP-R54AW-19,-33	L55
C41V	VC34A	L64
C42	EUP-054J	S21
C42K		S31

{3}------------------------------------------------

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of 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/cdrh/industry/support/index.html.

Sincerely yours.

Smh

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications For Use

510(k) Number (if known): K130308

Noblus TM Ultrasound Diagnostic System Device Name:

Indications for Use:

The Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-raginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology, and Laparoscopic clinical applications.

The Modes of Operation of the 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, and Real Time Tissue Elastography,

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K130308

Page 1 of 19

Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System

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Device Name: Noblus™ Ultrasound Diagnostic System

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
Fetal Imaging& Other	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
	Adult Cephalic	P	P	P	P	P	P	P
	Trans-rectal	Ph	Ph	Ph		Ph	Ph	Ph
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.)
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.)

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

N = new indication. P = previously cleared in K102901

*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 amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery(excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, and 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 guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130308 510(k)

Page 2 of 19

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Noblus™ System: Transducer: C22K

Intended use: Diagnostic uttrasound imaging or fluid flow analysis of 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
Fetal Imaging& Other	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
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in K102901

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

** Amplitude Doppler (Color Flow Angiography)

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, and 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 guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K130308

Page 3 of 19

Special 510(K)Premarket Notification – Noblus™ Ultrasound Diagnostic System

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Noblus™ System: Transducer: C25

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of 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
Fetal Imaging& Other	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
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in K102901

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

**Amplitude Doppler (Color Flow Angiography)

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(excludes neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, and 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 guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130308 510(k) -

Page 4 of 19

Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System

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Noblus™ System: Transducer C41

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of 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.)	Pc	Pc	Pc		Pc	Pc	Pc
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P

N = new indication. P = previously cleared in K102901

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

**Amplitude Doppler (Color Flow Angiography)

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(excludes neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, and 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 guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130308 510(k)

Page 5 of 19

Special 510(K)Premarket Notification – Noblus™ Ultrasound Diagnostic System

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

System: Noblus™ Transducer: C41V

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of 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
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.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N = new indication. P = previously cleared in K102901

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

**Amplitude Doppler (Color Flow Angiography), 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.(excludes neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, and 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 guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130308 510(k)

Page 6 of 19

Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System

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

Noblus ™ System: Transducer: C42

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of 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
Fetal Imaging& Other	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	P
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)

N = new indication. P = previously cleared in K102901

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

** Amplitude Doppler (Color Flow Angiography), 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.
	(excludes neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, and 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 guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130308 510(k)

Page 7 of 19

Special 510(K)Premarket Notification ~ Noblus™ Ultrasound Diagnostic System

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

Noblus™ System: Transducer: C42K

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of 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
Fetal Imaging& Other	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
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in K102901

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

**Amplitude Doppler (Color Flow Angiography)

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(excludes neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, and 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 guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130308 510(k)

Page 8 of 19

Special 510(K)Premarket Notification – Noblus™ Ultrasound Diagnostic System

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

System:
Transducer:

Noblus™ EUP-CC531S

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of 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
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.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in K102901

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

**Amplitude Doppler (Color Flow Angiography), 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(excludes neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, and 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 guidance of trans-rectal biopsy.

rescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130308 510(k)

Page 9 of 19

Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System

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

Noblus TM System: EUP-054J Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of 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.)	Pb	Pb	Pb		Pb	Pb	Pb
	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.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)

N = new indication. P = previously cleared in K102901

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

** Amplitude Doppler (Color Flow Angiography), 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.(excludes neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, and 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 guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130308 210(K)

Page 10 of 19

Special 510(K)Premarket Notification – Noblus™ Ultrasound Diagnostic System

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

System:	Noblus TM
Transducer:	EUP-OL334

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of 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
Fetal Imaging& Other	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic	P	P	P		P	P	P
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N = new indication. P = previously cleared in K102901

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

**Amplitude Doppler (Color Flow Angiography), 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, and 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

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

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130308 210(k)

Page 11 of 19

Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System

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

System: Noblus™ EUP-R54AW-19, -33 Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of 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
Fetal Imaging& Other	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N = new indication. P = previously cleared in K102901

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

**Amplitude Doppler (Color Flow Angiography), 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(excludes neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, and 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 guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) _K130308

Page 12 of 19

Special 510(K)Premarket Notification ~ Noblus™ Ultrasound Diagnostic System

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

Noblus™ System: Transducer: L34

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of 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
Fetal Imaging& Other	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
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)

N = new indication. P = previously cleared in K102901

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

** Amplitude Doppler (Color Flow Angiography), 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 (excludes neurosurgery and laparoscopic procedures). ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, and 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 guidance of trans-rectal biopsy

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130308 510(k)

Page 13 of 19

Special 510(K)Premarket Notification ~ Noblus™ Ultrasound Diagnostic System

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

Noblus™ System: L44 Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of 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
Fetal Imaging& Other	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
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)

N = new indication. P = previously cleared in K102901

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

** Amplitude Doppler (Color Flow Angiography), 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

	(excludes neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, and 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 guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130308 510(k)

Page 14 of 19

Special 510(K)Premarket Notification – Noblus™ Ultrasound Diagnostic System

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

Noblus TM System: Transducer: ୮୧ର

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
Fetal Imaging& Other	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
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)

N = new indication. P = previously cleared in K102901

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

** Amplitude Doppler (Color Flow Angiography), 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.(excludes neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, and 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 guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130308 510(k)

Page 15 of 19

Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System

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

Noblus TM System: 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
Fetal Imaging& Other	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
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.)

N = new indication. P = previously cleared in K102901

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

** Amplitude Doppler (Color Flow Angiography), 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 (excludes neurosurgery and laparoscopic procedures). Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.

Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "e": Includes imaging for quidance of trans-rectal biopsy Subscript "f": Includes imaging for guidance of trans-vaginal biopsy. For pediatric patients Subscript "g": Subscript "h": Includes imaging for guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130308 510(k)

Page 16 of 19

Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System

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

System: Noblus™ Transducer: S21

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

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
Fetal Imaging& Other	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac 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 K102901

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

**Amplitude Doppler (Color Flow Angiography), Tissue Doppler 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, and 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 guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130308 510(k)

Page 17 of 19

Special 510(K)Premarket Notification – Noblus™ Ultrasound Diagnostic System

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

System: Noblus™ Transducer: S31

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of 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
Fetal Imaging	Abdominal	P	P	P	P	P	P	P
& Other	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
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult	P	P	P	P	P	P	P
	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N = new indication. P = previously cleared in K102901

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

** Amplitude Doppler (Color Flow Angiography), Tissue Doppler 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.(excludes neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, and 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 guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130308 510(k)

Page 18 of 19

Special 510(K)Premarket Notification ~ Noblus™ Ultrasound Diagnostic System

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

Noblus™ System: Transducer: VC34A

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows	NA AN AN ENDER SECTION CONSULTERIAL OR LEAN BERESHIP LEA	SERVICE AND R.E. BANK SECENTRAL LABORATE LE

Company of the country of the country of the county of the county of

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

N = new indication. P = previously cleared in K102901

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

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

Additional Comments:

Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery.(excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, and 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 guidance of trans-rectal biopsy.

Prescription Use Only (Per 21 CFR 801.109)

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

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

Port Start

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K130308

Page 19 of 19

Special 510(K)Premarket Notification - Noblus™ Ultrasound Diagnostic System

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.