Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the technology as having the "same essential technology for imaging, Doppler functions, and signal processing" as the predicate device, without mentioning any AI/ML components.

Therapeutic

No.
The device is described as an "Ultrasound Diagnostic System" for "diagnostic ultrasound evaluation," indicating its primary function is diagnosis rather than therapy.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states "The Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of..." followed by a list of clinical applications. Additionally, the modes of operation are typical of diagnostic ultrasound systems.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as ultrasound transducers, a computer system, and a video monitor, indicating it is a hardware-based system with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Noblus™ Ultrasound Diagnostic System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that the system is for "diagnostic ultrasound evaluation" of various anatomical sites and clinical applications. This involves using ultrasound waves to create images of internal structures for diagnosis.
Device Description: The description details components like transducers, a computer system for signal analysis, and a monitor to display images. These are characteristic of imaging systems, not devices that analyze samples in vitro (outside the body).
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples. IVD devices are specifically designed for such purposes.

Therefore, the Noblus™ Ultrasound Diagnostic System is an in vivo diagnostic imaging system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 (Spec.), Intra-operative (Neuro.), Transesophageal (Cardiac) - Adult/Pediatric, Wound (Cavernous/Non-Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, 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 (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, and Real Time Tissue Elastography.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

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) O in various modes of operation
A computer system to control the transducer and analyze the signals resulting from the reflected echoes O
A video monitor with optional image recorder to display the computed image or derived Doppler data O

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Cardiac, Intra-operative (Spec.), Intra-operative (Neuro.), Transesophageal (Cardiac), Wound (Cavernous/Non-Cavernous), Fetal, Small Organ, Peripheral vessel, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Intra-luminal, Gynecology, Urology. Transducers EUP-R54AW-19, -33 and R41R are indicated for Trans-rectal. Transducers C41B, C41V, C41V1, CC41R, EUP-CC531S are indicated for Trans-rectal and Trans-vaginal. Transducer C41 is indicated for Small Organ (thyroid, parathyroid, breast, scrotum, penis). Transducer C42 is indicated for Pediatric, Small Organ (thyroid, parathyroid, breast, scrotum, penis), Neonatal Cephalic. Transducer EUP-L53L is indicated for Small Organ (thyroid, parathyroid, breast, scrotum, penis). Transducer S31KP is indicated for Intra-operative (Neuro). Transducer S3ESS/S3ESL and S3ESEL and S3ESL1 are indicated for Trans-esophageal (non-Card.) and Trans-esophageal (cardiac). Transducer UST-2265-2 does not explicitly list anatomical sites but Cardiac and Peripheral Vessel are specified modes of operation for PWD and Other (spec.) for PWD.

Indicated Patient Age Range

Adult/Pediatric. Some transducers further specify Adult Cephalic and Pediatric, and some Trans-esophageal applications specify "For Adult and Pediatric patients".

Intended User / Care Setting

Trained personnel (doctor, sonographer, etc.)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

No new hazards were identified with the subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142368

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they appear to be layered or overlapping. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

December 6, 2016

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

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

Re: K160559

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: October 13, 2016 Received: October 14, 2016

Dear Ms. Van Arsdale:

This letter corrects our substantially equivalent letter of October 18, 2016.

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

1

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 Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours

Jeff Rothen

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

Enclosure

2

Indications for Use

510(k) Number (if known)

Device Name

NOBLUSTM Ultrasound Diagnostic System

Indications for Use (Describe)

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 (Spec.), Intra-operative (Neuro.), Transesophageal (Cardiac) - Adult/Pediatric, Wound (Cavernous/Non-Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, 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 (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, and Real Time Tissue Elastography.

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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Transducer:	All connectable probes
	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
Doppler	Combined*
(Spec.)	Other**
(Spec.)
(Track I only)	(Tracks I & III)
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.)	N	N	N		N	N	N
	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	Adult Cephalic	P	P	P	P	P	P	P
& Other	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)	Pg	Pg	Pg		Pg	Pg	Pg
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.) - Wound	Ph	Ph	Ph		Ph	Ph	Ph
	Other (spec.) - Gynecological	P	P	P		P	P	P
	Other (spec.) - Endoscopy	P	P	P		P	P	P
	Other (spec.) -
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (card.)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	P	P	P
Vessel	Other (spec.) -
	N = new indication. P = previously cleared in K142368
*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW,
TDI-B/B. TDI-B/M, TDI-B/PW
** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, 4D Imaging, Omni Directional M mode, Wide View,
Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes 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)

Noblus

System:

(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:_

4

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System:	Noblus
Transducer:	C221
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	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal	P	P	P		P	P	P
	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.) - Wound
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

(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:_

5

System:	Noblus
Transducer:	C22K
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	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
	CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

(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:________________________________________________________________________________________________________________________________________________________________

6

System:	Noblus
Transducer:	C22P
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Clinical Application	General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic	Fetal	P	P	P	P	P	P
		Abdominal	Pa	Pa	Pa	Pa	Pa	Pa
Fetal Imaging
& Other		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
		Other (spec.) - Gynecological
		Other (spec.) - Endoscopy
		Other (spec.) -
Cardiac		Cardiac Adult
		Cardiac Pediatric
		Trans-esophageal (card.)
		Other (spec.)
Peripheral
Vessel		Peripheral vessel
		Other (spec.) -
N= new indication. P = previously cleared in K142368
*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

(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

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		DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System:	Noblus
Transducer:	C22T
	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
Doppler	Combined*
(Spec.)	Other**
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P
	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)

Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N= new indication. P = previously cleared in K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW,
	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

(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:_

8

System:	Noblus
Transducer:	C25
	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
Doppler	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	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	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 K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes 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 ANOTHIER PAGE IF NEEDED)

9

System:	Noblus
Transducer:	C251
	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
Doppler	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	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	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 K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes 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:_

10

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	Color
Doppler	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View,
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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(Division Sign – Off)
Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:_

11

						DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
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	Specific	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
(Track I only)	(Tracks I & III)
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	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	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 K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, CFM-B/CFM-B/CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View,
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)

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12

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System:	Noblus
Transducer:	C41B
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	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)

Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
CFM-B/PW	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

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

13

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	Specific	B	M	PWD	CWD	Color
Doppler	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	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
CFM-B/PW	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Tissue Elastography

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

14

		DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
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	Specific	B	M	PWD	CWD	Color	Combined*	Other**
(Track I only)	(Tracks I & III)					Doppler	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological	P	P	P		P	P	P
	Other (spec.) - Endoscopy
	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 K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

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

15

		DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
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	Specific	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal	Pe	Pe	Pe		Pe	Pe	Pe
	Trans-vaginal	Pf	Pf	Pf		Pf	Pf	Pf
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological	P	P	P		P	P	P
	Other (spec.) - Endoscopy
	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 K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

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

16

System:	Noblus
Transducer:	C42
	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
Doppler	Combined*
(Spec.)	Other**
(Spec.)
(Track I only)	(Tracks I & III)
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	P
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)	P	P	P		P	P	P
Peripheral	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
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:_

ହ

17

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System:	Noblus
Transducer:	C42K
	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 Doppler	Combined* (Spec.)	Other** (Spec.)
(Track I only)	(Tracks I & III)
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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View

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
Duranamissioner Il
n.I.	1000 21 CED 901 1001

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18

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System:	Noblus
Transducer:	C42T
	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
Doppler	Combined*
(Spec.)	Other**
(Spec.)
(Track I only)	(Tracks I & III)
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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N= new indication. P = previously cleared in K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparossopic 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

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

19

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
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	Color
Doppler	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

(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 of Radiological Health 510(k) Number:___

20

System:	Noblus	DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
Transducer:	EUP-B512
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Clinical Application	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
General
(Track I only)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
Fetal Imaging
& Other	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
N = new indication. P = previously cleared in K142368
*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW,
CFM-B/PW
**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy.
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and Pediatric patients.
Subscript "h": Includes imaging for Cavernous/Non-Cavernous wounds

(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:_

21

		DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System:	Noblus
Transducer:	EUP-B715
	Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
						Mode of Operation
Clinical Application	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
General
(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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging

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

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

22

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	Specific	B	M	PWD	CWD	Color
Doppler	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	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	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 K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes 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)

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

23

System:	Noblus
Transducer:	EUP-CC531S
	Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Clinical Application						Mode of Operation		Other**
General	Specific	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging
& 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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW

	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes 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:_

24

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
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	Color Doppler	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.) -
	N= new indication. P = previously cleared in K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
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

测

1:

(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:________________________________________________________________________________________________________________________________________________________________

25

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
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	Specific	B	M	PWD	CWD	Color
Doppler	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	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	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 K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

(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) Office of In Vitro Division of Radiological Health
Office of In Vitro Diagnostic and Radiological Health 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

.

26

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
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	Specific					Color	Combined*	Other**
(Track I only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)	PbPbPbPbPbPb
	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	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 K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

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

27

				DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
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	Specific	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)	P	P	P		P	P	P
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	P	P	P
Vessel	Other (spec.) -
	N= new indication. P = previously cleared in K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time 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

(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

28

System:	Noblus
Transducer:	EUP-0732T
	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	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)

Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes 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)

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

29

System:	Noblus
Transducer:	EUP-OL334
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Clinical Application						Mode of Operation	Combined*
(Spec.)	Other **
(Spec.)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler
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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes 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: _________________________________________________________________________________________________________

30

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System:	Noblus
Transducer:	EUP-R54AW-19, -33
	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	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

(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:_

31

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	Color
Doppler	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Contrast Ime 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

8

32

System:	Noblus
Transducer:	L43K
	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.)	Pb	Pb	Pb		Pb	Pb	Pb
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	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 K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes 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)

్రాప్ట్

(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:___

33

					DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
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	Specific	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	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 K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

(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:_

.

34

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
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	Color Doppler	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)

Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	P
	Other (spec.) -
	N= new indication. P = previously cleared in K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

(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:________________________________________________________________________________________________________________________________________________________________

35

System:	Noblus
Transducer:	L44LA
	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.)	P	P	P		P	P	P
	Intra-operative (Neuro.)
	Laparoscopic	P	P	P		P	P	P
	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	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 K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, CFM-B/CFM-B/CFM-B/CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Contrast Imaging, Real Time Tissue Elastography

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

36

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System:	Noblus
Transducer:	L44LA1
	Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Clinical Application						Mode of Operation
General	Specific					Color	Combined*	Other **
(Track I only)	(Tracks I & III)	B	M	PWD	CWD	Doppler	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)	P	P	P		P	P	P
	Intra-operative (Neuro.)
	Laparoscopic	P	P	P		P	P	P
	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	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 K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View
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

(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:_

37

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	Specific	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other **
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.) - Wound	Ph	Ph	Ph		Ph	Ph	Ph
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	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 K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	**Amplitude Doppler (Color Flow Angiography, Omni Directional M mode, Wide View, Contrast Imaging, Real Time Tissue Elastography

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

。

38

					DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
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	Specific	B	M	PWD	CWD	Color Doppler	Combined*	Other **
(Track I only)	(Tracks I & III)						(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	Pa	Pa	Pa		Pa	Pa	Pa
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Spec.)	Pd	Pd	Pd		Pd	Pd	Pd
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)	P	P	P		P	P	P
	Musculo-skel. (Superfic.)	P	P	P		P	P	P
	Intra-luminal
	Other (spec.) - Wound	Ph	Ph	Ph		Ph	Ph	Ph
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	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 K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time 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

(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:

39

				DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
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		M	PWD	CWD	Color	Combined*	Other **
(Track I only)	(Tracks I & III)	B				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	P	P	P		P	P	P
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	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 K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, CFM-B/CFM-B/CFM-B/CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Real Time Tissue Elastography

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

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(E

40

		DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
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	Specific	B	M	PWD	CWD	Color	Combined*	Other **
(Track I only)	(Tracks I & III)					Doppler	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Spec.)
	Neonatal Cephalic
Fetal Imaging	Adult Cephalic	P	P	P	P	P	P	P
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (card.)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	P	P	P
Vessel	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
	CFM-B/PW, TDI-B/B. TDI-B/M, TDI-B/PW
	** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode, Contrast Imaging
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

(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:________________________________________________________________________________________________________________________________________________________________ -

41

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System:	Noblus
Transducer:	S211
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Clinical Application	Specific
(Tracks I & III)	Mode of Operation
General
(Track I only)		B	M	PWD	CWD	Color Doppler	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
Cardiac	Cardiac Adult	P	P	P	P	P	P	P
	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P	P
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
	CFM-B/PW, TDI-B/B. TDI-B/M, TDI-B/PW
	**Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode, Contrast Imaging

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

র

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

42

		Mode of Operation
System:	Noblus
Transducer:	S31
	Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Clinical Application	Specific
(Tracks I & III)	B	M	PWD	CWD	Color Doppler	Combined*
(Spec.)	Other**
(Spec.)
General
(Track I only)
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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
Cardiac	Cardiac Adult	P	P	P	P	P	P	P
	Cardiac Pediatric	P	P	P	P	P	P	P
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
	CFM-B/PW,TDI-B/B. TDI-B/M, TDI-B/PW
	**Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode

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

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

(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 of Radiological Health
Office of In Vitro Division of Radiological Health
Office of In Vitro Diagnostic and Radiological Health 510(k) Number:________________________________________________________________________________________________________________________________________________________________

43

System:	Noblus
Transducer:	S31KP
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Clinical Application	Specific
(Tracks I & III)	Mode of Operation
General
(Track I only)		B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)	N	N	N		N	N	N
	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
N = new indication. P = previously cleared in K142368
*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW
**Amplitude Doppler (Color Flow Angiography), Omni Directional M mode
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes 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:__________________________________________________________________________________________________________

44

		DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System:	Noblus
Transducer:	S3ESS/S3ESL
	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
Doppler	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.)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW,
	CFM-B/PW, TDI-B/B. TDI-B/M, TDI-B/PW
	** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode

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

ા ગુજરાત રાજ્યના ઉ

ଲ

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

ା

45

	DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
--	------------------------------------------------

System:	Noblus
Transducer:	S3ESEL
	Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Mode of Operation
Clinical Application
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.)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
	CFM-B/PW, TDI-B/B. TDI-B/M, TDI-B/PW
	** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

(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)

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Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

46

			Mode of Operation
System:	Noblus
Transducer:	S3ESL1
	Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Clinical Application	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other**
(Spec.)
General
(Track I only)	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.)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) - Wound
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)	Pg	Pg	Pg	Pg	Pg	Pg	Pg
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
	CFM-B/PW, TDI-B/B. TDI-B/M, TDI-B/PW
	**Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

(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:_

47

System:	Noblus
Transducer:	VC34A
	Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Clinical Application		Mode of Operation
General	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Spec.)	Other **
(Spec.)
(Track I only)
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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 4D Imaging, Omni Directional M mode

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

48

System:	Noblus
Transducer:	UST-2265-2
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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy
	Other (spec.) -
	Cardiac Adult			P
Cardiac	Cardiac Pediatric			P
	Trans-esophageal (card.)
	Other (spec.)			P
Peripheral	Peripheral vessel			P
Vessel	Other (spec.) -
	N = new indication. P = previously cleared in K142368

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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49

				DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System:	Noblus
Transducer:	EB-1970UK
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Clinical Application		Mode of Operation
General	Specific			PWD	CWD	Color	Combined*	Other **
(Track I only)	(Tracks I & III)	B	M			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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy	P	P	P		P	P	P
	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 K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, CFM-B/CFM-B/CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, 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":	For Adult and Pediatric patients.
Subscript "g":
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

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

50

System:	Noblus
Transducer:	EG-3270UK
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
Doppler	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy	P	P	P		P	P	P
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N = new indication. P = previously cleared in K142368
	* Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes 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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51

		DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System:	Noblus
Transducer:	EG-3670URK
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
Doppler	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
	Other (spec.) - Gynecological
	Other (spec.) - Endoscopy	P	P	P		P	P	P
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)

Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N= new indication. P = previously cleared in K142368
*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g":	For Adult and Pediatric patients.
Subscript "h":	Includes imaging for Cavernous/Non-Cavernous wounds

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510(k) Number: _________________________________________________________________________________________________________

52

System:	Noblus
Transducer:	EG-3870UTK
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	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
	Other (spec.) - Gynecological						P	P
	Other (spec.) - Endoscopy	P	P	P		P	P	P
	Other (spec.) -
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)

Peripheral
Vessel	Peripheral vessel
	Other (spec.) -
	N= new indication. P = previously cleared in K142368
*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,
CFM-B/PW
	**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging, Real Time Tissue Elastography
Additional Comments:
Subscript "a":	Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b":	Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c":	Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d":	Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e":	Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":	Includes 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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Office of In Vitro Diagnostic and Radiological Health 510(k) Number:_

53

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 On behalf of HITACHI, LTD 2-16-1, Higashi-Ueno, Taito-ku Tokyo, 110-0015, JAPAN

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

Date Prepared: October 17, 2016

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

Device Proprietary Name – NOBLUS™ Ultrasound Diagnostic System Common name - Ultrasound Diagnostic 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

1. Legally Marketed Predicate Device(s):
  Noblus™ Ultrasound Diagnostic System (K142368)

4. Device Description:

An ultrasound diagnostic system with the following features:

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

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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.), Intra-operative (Neuro), Trans-esophageal (Cardiac) – Adult/Pediatric, Wound (Cavernous/Non-Cavernous/Non-Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology, and Laparoscopic clinical applications.

The modes of Operation of the Hitachi Noblus™ Ultrasound Diagnostic System are B mode, M 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

1. Comparison to predicate device:
  The Hitachi NOBLUS™ Ultrasound Diagnostic System is equivalent to the predicate devices the Hitachi Noblus (K142368). The NOBLUS™ has been modified to include an additional indication, additional probes / accessories and new materials of manufacture that fall within predicate material specifications. The subject and predicate devices are Track III systems.

| | Predicate Device
Noblus
(K142368) | Subject Device
Noblus |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended 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 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.), Intra-operative (Neuro),
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 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. | 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, 4D Imaging, and Real Time Tissue
Elastography. |
| FDA Track: | 1 probe / 3 probes (with Probe extension unit) | 1 probe / 3 probes (with Probe extension unit) |
| Probes: | Convex, Linear, Sector, 4D, Other, EUS | Convex, Linear, Sector, 4D, Other, EUS |
| Transmit Channel: | 64 | 64 |
| Display Modes: | Combinations of
B, B/B, B/M, M, B/PW, PW, CW, B/CW, CFM-
B/CW, CFM-B, CFM-B/CFM-B, CFM-B/CFM-
M, CFM-M, CFM-B/PW, TDI-B,TDI-B/B,TDI-
B/M, TDI-M,TDI-B/PW,TDI-PW | Combinations of
B, B/B, B/M, M, B/PW, PW, CW, B/CW, CFM-
B/CW, CFM-B, CFM-B/CFM-B, CFM-B/CFM-
M, CFM-M, CFM-B/PW, TDI-B,TDI-B/B,TDI-
B/M, TDI-M,TDI-B/PW,TDI-PW |

55

21 CFR Part 807.92, Section b

1. Non-clinical Testing

No new hazards were identified with the subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.

2. Clinical testing:

None required

3. Conclusions:

The Noblus™ Ultrasound Diagnostic scanner is substantially equivalent in safety and effectiveness to the predicate device;

. The subject and predicate device(s) are both indicated for ultrasound Diagnostic imaging and fluid flow analysis.
. The subject and predicate device(s) have the same gray scale and Doppler capabilities.
. The subject and predicate device(s) have the same essential technology for imaging, Doppler functions, and signal processing.
. The subject and predicate device(s) have acoustic level below the Track 3 FDA limits.
. The subject and predicate device(s) are manufactured in accordance to FDA 21 CFR 820 Quality System Regulations.
. The subject and predicate device(s) are designed and manufactured to the same electrical and physical safety standards.
. The subject and predicate device(s) are manufactured with materials that have been tested in accordance to ISO 10993-1; all biocompatibility testing has been conducted in accordance to each component material characterization, type of body contact, and duration contact risk profile.
. The subject and predicate device(s) are designed to be re-usable and provide instructions for cleaning, disinfection, and sterilization in the Ultrasound system and transducer manuals.

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

§ 892.1550 Ultrasonic pulsed doppler imaging system.

Indications for Use

Indications for Use (Describe)

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Prescription Use Only (per 21 CFR 801.109)

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

4. Device Description:

21 CFR Part 807.92, Section b

1. Non-clinical Testing

2. Clinical testing:

None required

3. Conclusions:

END OF SUMMARY