The device is intended for use by a qualified physician for ultrasound evaluation of the Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Transvaginal , Trans-rectal, Gynecological and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Transrectal, Transvaginal, Fetal, Abdominal, Gynecological, Cardiac, Peripheral Vascular, Small Organ, Intra-operative, Neonatal Cephalic.

Device Description

The Prosound Alpha 6 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display.

AI/ML Overview

This is a 510(k) premarket notification for the Aloka Prosound Alpha 6 Diagnostic Ultrasound System. It is focused on demonstrating substantial equivalence to a predicate device (Aloka SSD-4000 K040719), rather than establishing new performance criteria or efficacy through clinical trials. As such, the document does not contain the typical details of a study designed to prove a device meets specific acceptance criteria in the way an AI/CADe device approval would.

Here's an breakdown based on the provided text, highlighting the absence of information typically requested for AI/CADe approvals:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific performance metrics or acceptance criteria for the Aloka Prosound Alpha 6 in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) that would typically be expected for a device proving novel diagnostic capabilities. Instead, the "acceptance criteria" are implied to be technical comparability and conformance to safety standards, and the "performance" is stated as being "substantially equivalent" to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Technical comparability to predicate device (Aloka SSD-4000 K040719)	"technically comparable and substantially equivalent"
Same technological characteristics as predicate device	"has the same technological characteristics"
Same key safety and effectiveness features as predicate device	"has the same key safety and effectiveness features"
Same intended uses and basic operating modes as predicate device	"has the same intended uses and basic operating modes"
Conformance with applicable medical device safety standards	"found to conform with applicable medical device safety standards"
Compliance with 21 CFR 820, ISO 9001:2000, ISO 13485 quality systems	"confirms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems"
Safe and effective performance (as per diagnostic ultrasound history)	"Diagnostic ultrasound has accumulated a long history of safe and effectiveness performance."

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

The document explicitly states "None Required" for clinical tests for the purpose of demonstrating substantial equivalence. Therefore, there is no test set, sample size, or data provenance relevant to proving diagnostic performance against predefined acceptance criteria. Clinical practices, FDA guidelines, and established patient examination methods are cited as sufficient to confirm intended uses and features.

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

Since no clinical test set was used to assess diagnostic performance of the new device itself, there were no experts used to establish ground truth in this context. The "ground truth" for the substantial equivalence claim relies on the established safety and effectiveness of the predicate device and the general understanding of diagnostic ultrasound.

4. Adjudication Method for the Test Set

As there was no clinical test set, there was no adjudication method employed.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. This submission focuses on substantial equivalence based on technical specifications and established safety, not on improving human reader performance with or without AI assistance.

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

The Aloka Prosound Alpha 6 is a diagnostic ultrasound system, not an AI or algorithm-only device. Therefore, a standalone algorithm performance study was not applicable and not conducted. It's a medical imaging hardware and software system used by humans.

7. The Type of Ground Truth Used

The concept of "ground truth" as it applies to diagnostic accuracy for a new device's performance is not directly addressed. Instead, the ground truth for this 510(k) submission is the established safety and effectiveness record of the predicate device (Aloka SSD-4000) and general diagnostic ultrasound technology. The "truth" is that its technical characteristics and intended uses align with a device already cleared by the FDA, implying similar safety and effectiveness.

8. The Sample Size for the Training Set

The Aloka Prosound Alpha 6 is a traditional ultrasound system, not an AI/ML device that requires a training set in the computational sense. Therefore, there is no training set mentioned or applicable.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

Summary

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Aloka Co. Ltd.

Model Prosound Alpha 6

510(K)

NOV 20 2009

K0931/88

510(k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92

Section a): Aloka Co., Ltd., 10 Fairfield Boulevard, Wallingford, CT 06492 1. Submitter: Richard J. Cehovsky, RA/QA Mingr., Contact Person: Tcl: (203)269-5088 Ext. 346, Fax: 203-269-6075 10/12/09 Date Prepared: Aloka Prosound Alpha 6 Diagnostic Ultrasound System 2. Device Name: Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550 , 90 IYN Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90 ITX Ultrasonic Pulsed Echo Imaging System., 21 CFR 892.1560, 90 IYO 3. Marketed Device: Aloka SSD-4000 Diagnostic Ultrasound System K040719, (90-TYN, ITX, IYO) ( A device currently in commercial distribution) 4. Device Description: The Prosound Alpha 6 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display. 5. Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of the Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Transvaginal , Trans-rectal, Gynecological and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications. 6.Comparison w/ Predicate Device: The Aloka Prosound Alpha 6 is technically comparable and substantially equivalent to the current Aloka SSD-4000-(K040719). It has the same technological characteristics, key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate device. Section b): I. Non-clinical Tests: The 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 with applicable medical device safety standards. None Required. 2. Clinical Tests: Intended uses and other key features are consistent with traditional clinical practices, FDA 3. Conclusion: guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effectiveness performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka Prosound Alpha 6 Diagnostic Ultrasound System and its transducers are substantially equivalent with respect to safety and effectiveness to its predicate and other currently cleared Aloka systems.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The bird is oriented diagonally, facing towards the upper right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

FEB 2 2 2010

Aloka Co., Ltd. % Mr. Tamas Borsai Division Manager, Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K093488

Trade/Device Name: Aloka Prosound Alpha 6 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: November 10, 2009 Received: November 10, 2009

Dear Mr. Borsai:

This letter corrects our substantially equivalent letter of November 20, 2009.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Aloka Prosound Alpha 6 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

UST-676P ASU-1010 UST-2266-5 UST-5293/52938-5 UST-5299 UST-5413

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Diagnostic Ultrasound Indications for Use Form UST-676P (K023996)

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

Clinical Application	B	M	PWD	Combined(specify)	Other (s
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P	See Below	No
Transvaginal	P	P	P	See Below	No
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventionalMusculo-skeletal Superficial
Other:

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

Additional Comments: Combined includes: BM, BPWD, MICD, B/CD/PWD, Note I: Mflow, B/Bflow, Power flow).

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Devic

510(k) Number__

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Diagnostic Ultrasound Indications for Use Form ASU-1010 (K043196)

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal		P	P	P					See Below	Note 1
Abdominal		P	P	P					See Below	Note 1
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other: Gynecological		P	P	P					See Below	Note 1

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

Additional Comments: Combined includes: BM, BPWD, MCD, B/CD/PWD, Note I: Mflow, B/Blow, Power flow).

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

vision Sign Off

(Division Sign-Off) Division of Reproductive, Abdon and Radiological Dev 510(k) Number

· :

....

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Diagnostic Ultrasound Indications for Use Form UST-2266-5 (K020668)

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeVelocity	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological-
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac					P
Transesophageal
Transrectal
Transvaginal-
Transurethral
Intravascular
Peripheral Vascular					P
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Helet Reine
(Division Sign-Off)

(Division of Reproductive, Abdominal, and Radiological Devic

510(k) Number K093488

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Diagnostic Ultrasound Indications for Use Form UST-5293/52938-5 (K003739)

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeVelocity	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P				See Below	Note 1
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other:

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

Additional Comments: Combined includes: BM, BPWD, MCD, BVCD/PWD, Note 1: Mlow, BlBlow, Power Bowl,

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Jules Ren

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device

510(k) Number

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

ﺀ ، ﻳﺴﻤ

Diagnostic Ultrasound Indications for Use Form UST-5299 (K003739)

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

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeVelocity	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P				See Below	Note 1
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other:

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

Additional Comments: Combined includes: BM,BPWD, MCD, BICD/PWD, BICWD, Note 1: MBow, BB00W, Power flow).

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

ivision Sign-Off

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic

510(k) Number K0913

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

Diagnostic Ultrasound Indications for Use Form UST-5413 (K992663)

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeVelocity	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)		P	P	P					See Below	Note 1
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P					See Below	Note 1
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other:

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

Additional Comments: Combined includes: BM, BPWD, MCD, B/CD/PWD, Note I: Mllow, B/Bflow, Power flow), Applications: Small Parts: (breast, testes, thyroid ... )

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Prescription

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devi 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form UST-9123 (K003739)

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeVelocity	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal		P	P	P					See Below	Note I
Abdominal		P	P	P					See Below	Note 1
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other: Gynecological		P	P	P					See Below	Note 1

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

Additional Comments: Combined includes- BM, BPWD, Note 1: Mlow, BBBlow, Power flow).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off Division of Reproductive, Abdominal and Radiological Device

510(k) Number K693488

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

Diagnostic Ultrasound Indications for Use Form UST-9124 (K003739)

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeVelocity	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal		P	P	P					See Below	Note 1
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal		P	P	P					See Below	Note 1
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other: Gynecological		P	P	P					See Below	Note 1

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

Additional Comments: Combined includes: BM, BPWD, NJCD, B/CD/PWD, Note I: MBow, B/Bflow, Power flow).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

ulu deme
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form UST-9127 (K060059)

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeVelocity	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal		P	P	P					See Below	Note 1
Abdominal		P	P	P					See Below	Note 1
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other: Gynecological		P	P	P					See Below	Note 1

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

Additional Comments: Combined includes: BM, BPWD, MCD, BCDPWD, Note I: Millow, B/Bflow, Power flow),

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

HubReem

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(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 51/VV) Numher

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

Diagnostic Ultrasound Indications for Use Form UST-9133 (K060059)

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeVelocity	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)		P	P	P					See Below	Note 1
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic		P	P	P					See Below	Note 1
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other:

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

Additional Comments: Combined includes: BAM, BPWD, N/CD, B/CD/PWD, Note I: Milow, B/Blow, Power flow). Applications: Intra-operative- (liver, pancreas, gall bladder..)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Concurrenc
F

(Division Sign Off) (Division of Reproductive, Abdominal, and Radiological Devic

510(k) Number_

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.