Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Laparoscopic, Intraoperative Abdominal, and Other Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Device Description

The 7340 is a portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Multi View (MView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The 7340 is equipped with a LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The 7340 can drive phased (PA), convex (CA), linear array (LA), Doppler probes and BiScan probes. The 7340 is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (hard-disk, PC, server) via a LAN/USB port. Optional accessory devices available for the 7340 include an S-VHS video recorder; a monochrome or color page printer and a mobile trolley equipped with an insulation transformer.

AI/ML Overview

The provided document is a 510(k) summary for the Esaote 7340 Ultrasound System, submitted to the FDA in 2008. It primarily details the device's intended use and compares its technological characteristics to predicate devices for demonstrating substantial equivalence.

Crucially, this document does NOT contain information about specific acceptance criteria, studies proving device performance against those criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, or the type of ground truth used.

The tables within the document (pages 8-10, 15-16) list the clinical applications and modes of operation available on the 7340 system and its predicate devices, as well as for various transducers. The 'N' and 'P' in these tables indicate whether a particular clinical application and mode is 'New' (first introduced with this device for that application) or 'Previously cleared' (using transducers approved in prior submissions) for the specific transducer being discussed. This is a comparison for substantial equivalence, not a performance study against acceptance criteria.

Therefore, I cannot provide the requested information from this document. The sections you asked for are typically found in detailed performance studies, clinical trials, or validation reports, which are not included in this 510(k) summary.

Summary

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K081794

807.92(a)(5)

JUL 1 0 2008

Intended Use(s) 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).

807.92(a)(1)

Submitter Information

Carri Graham Anson Group 11460 N. Meridian St., Ste. 150 Carmel, IN 46032 Phone: (317) 569-9500 x 103 Facsimile: (317) 569-9520

Contact Person: Carri Graham

Date: June 3, 2008

807.92(a)(2)

Trade Name: 7340 Ultrasound System

Common Name: Ultrasound Imaging System

Classification Name(s): Ultrasonic pulse Doppler imaging system 892.1550 Ultrasonic pulsed echo imaging system 892.1560

Classification Number: 90IYN, 90IYO

807.92(a)(3)

Predicate Device(s)

K040596, K052805 &K060827	7300 (MyLab30)	Esaote, S.p.A.
K051837 & K060827	6100 (MyLab90)	Esaote, S.p.A.

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807.92 (a)(4)

Device Description

807.92(a)(5)

Intended Use(s)

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807,92(a)(6)

1 1

Technological Characteristics

	7340 (Thissubmission)	7300 (K040596,K052805 andK060827)	6100(K051837 andK060827)	Acuson P10(K063761)
Electrical Safety	IEC60601-1	IEC60601-1	IEC60601-1	EN60601-1
Ultrasound Safety	Track 3 (AcousticOutput Display)	Track 3 (AcousticOutput Display)	Track 3 (AcousticOutput Display)	Unknown
Indication for Use
• Cardiac	YES	YES	YES	YES
• TransesophagealCardiac	YES	YES	YES	Unknown
• Peripheral Vascular	YES	YES	YES	Unknown
• Neonatal Cephalic	YES	YES	YES	Unknown
• Adult Cephalic	YES	YES	YES	YES
• Small organ	YES	YES	YES	Unknown
• Musculoskeletal(conventional &superficial)	YES	YES	YES	Unknown
• Abdominal	YES	YES	YES	YES
• OB/Fetal	YES	YES	YES	YES
• Transvaginal	YES	YES	YES	Unknown
• Transrectal	YES	YES	YES	Unknown
• Pediatric	YES	YES	YES	YES
Intraoperative	YES	YES	YES	Unknown
Laparoscopic	YES	NO	YES	Unknown
Other: Urological	YES	YES	YES	Unknown
Probe Technology
• Phased Array	YES	YES	YES	YES
• Linear Array	YES	YES	YES	Unknown
• Convex Array	YES	YES	YES	Unknown
• Doppler Probes	YES	YES	YES	Unknown
• BiScan Probes	YES	YES	YES	Unknown
Modes of operation	2D, M-Mode,MView, PW, CW,CFM, AmplitudeDoppler, TEI, TVM	2D, M-Mode,MView, PW, CW,CFM, AmplitudeDoppler, TEI, TVM	2D, M-Mode, PW,CW, CFM,Amplitude Doppler,TEI	B, Color Doppler,Combined (B +Color Doppler)
Imaging Frequencies	2.5, 3.5, 4.0, 5.0, 6.6,7.5, 8.0, 10, 12, 15,18 MHz	2.5, 3.5, 4.0, 5.0, 6.6,7.5, 8.0, 10, 12, 15,18 MHz	1 - 16 MHz	2-4 MHz
CFM/DopplerFrequencies	2.0, 2.5, 2.9, 3.3, 4.0,5.0, 6.6, 8.0 MHz	2.0, 2.5, 2.9, 3.3, 4.0,5.0, 6.6, 8.0 MHz	2 - 12 MHz	Unknown
Biopsy Guidance	YES	YES	YES	Unknown
Biopsy Intended Uses	General Purpose	General Purpose	General Purpose	Unknown
	7340 (Thissubmission)	7300 (K040596,K052805 andK060827)	6100(K051837 andK060827)	Acuson P10(K063761)

	Transrectal,Transvaginal,Intraoperative	Transrectal,Transvaginal,Intraoperative	Transrectal,TransvaginalIntraoperative
• Biopsy Line Depthmarker	1 cm	1 cm	1 cm	Unknown
Needle Guide Angle	ABS15: 45°ABS33: 90°ABS523: 45°ABS621: 25° 35°	ABS15: 45°ABS33: 90°ABS523: 45°ABS621: 25° 35°	ABS15: 45°ABS523: 45°ABS621: 25° 35°	Unknown
Display type	LCD	LCD	CRT	LCD
Display Standard	SVGA	SVGA	SVGA	Unknown
Digital ArchivalCapabilities	YES	YES	YES	Unknown
DICOM Classes:Media Storage, StorageSCU, Worklist, MPPSand StorageCommitment, Print	YES	YES	Media Storage,Storage SCU	Unknown
VCR / Page Printer	YES	YES	YES	Unknown
M&A Capabilities	Cardiac, Vascular,Urological,Gynaecological, OBand general purposemeasurements	Cardiac, Vascular,Urological,Gynaecological,OBand general purposemeasurements	Cardiac, Vascular,OB and generalpurposemeasurements	Unknown
Advanced Tools	3D/4D, VPan, StressEcho, Strain andStrain Rate analysis,Intima-MediaThickness	3D/4D, VPan, StressEcho, Strain andStrain Rate analysis,Intima-MediaThickness	3D/4D, Stress Echo,Strain and StrainRate analysis,Intima-MediaThickness	Unknown
Weight	portable: about 11 kgwith battery installedwith trolley: 46 kg	portable: 10 kgwith trolley: 40 kg	120 kg	Unknown
Dimensions	portable position:38.2 (w) x 16.5 (h) x49 (d) cmuse position:38.2 (w) x 43 (h) x49 (d) cmwith trolley:50 (w) x 133 (h) x 51(d) cm	portable position:35.5 (w) x 14 (h) x49 (d) cmuse position:35.5 (w) x 41 (h) x49 (d) cmwith trolley:50 (w) x 130 (h) x 51(d) cm	60(w) x 160 (h) x120(d) cm	54mm (h) x 97mm(w) x 137mm (l)
Internal Lithium IonBattery	Yes	No	No	Yes

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 10 2008

Esaote, S.p.A % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K081794

Trade/Device Name: 7340 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: ITX, IYN, and IYO Dated: June 24, 2008 Received: June 25, 2008

Dear Mr. Job:

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 7340 Ultrasound System, as described in your premarket notification:

Transducer Model Number

PA230
PA122
LA332
LA523
C5-2
CA123

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Image /page/5/Picture/1 description: The image shows a list of alphanumeric codes. The codes are CA531, CA631, 2 CW, 5 CW, EC1123, TRT33, TEE022, TEE122, IOE323, LP323, BS230, and BC431. Each code is on a separate line. Some of the codes contain only letters and numbers, while others contain a combination of letters, numbers, and spaces.

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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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

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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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.

Sincerely yours,

lomethting

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Indications for Use

510(k) Number (if known):

Device Name: 7340 Ultrasound System

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Aruin M. Wry

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

ન ક

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Mod.7340

Clinical Application	Mode of Operations
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal	N	N	N	N	N	N	N		N	5, 6, 7, 8, 9, 10
Abdominal	N	N	N	N	N	N	N		N	5, 6, 7, 8, 9
Intraoperative (Abdominal)	N	N	N	N	N	N	N		N	5, 6, 8, 9, 13
Intraoperative Neurological
Pediatric	N	N	N	N	N	N	N		N	5, 6, 8, 9, 13
Small Organ [1]	N	N	N	N	N	N	N		N	4, 5, 6, 8, 9, 13
Neonatal Cephalic	N	N	N	N	N	N	N		N	5, 6, 8, 9
Adult Cephalic	N	N	N	N	N	N	N		N	6, 8, 9
Cardiac [2]	N	N	N	N	N	N	N	N	N	4, 6, 7, 8, 9, 11,12
Transesophageal (Cardiac)	N	N	N	N	N	N	N	N	N	4, 6, 9, 11, 12
Transesophageal (Non Cardiac)
Transrectal	N	N	N	N	N	N	N		N	5, 6, 8, 9, 13
Transvaginal	N	N	N	N	N	N	N		N	5, 6, 8, 9
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N	N		N	5, 6, 7, 8, 9, 10,12, 13
Laparoscopic	N	N	N	N	N	N	N		N	5, 6, 8, 9, 13
Musculo-skeletal Conventional(including Nerve Blocking)	N	N	N	N	N	N	N		N	4, 5, 6, 8, 9, 13
Musculo-skeletal Superficial(including Nerve Blocking)	N	N	N	N	N	N	N		N	4, 5, 6, 8, 9, 13
Other (Urological)	N	N	N	N	N	N	N		N	5, 6, 8, 9

ារ
ប្រជាជនជាតិ ជា

Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric

ted modes are: B + M + PW + CW + CFM + PD

[3]	Combine
[4]	CMM
[5]	MView
[6]	3D
[7]	4D
[8]	VPan
[9]	XView
[10]	QIMT
[11]	Stress
[12]	Strain
[13]	TP View

Lora M. Whitney

(Division Sign-Off) (Division Signi-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number --

. . . . .

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	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhacementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P		P	6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P		P	6, 8, 9
Cardiac [2]	P	P	P	P	P	P	P	P	P	4, 6, 8, 9, 11,12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
oscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial (includingNerve Blocking)
Other (Urological)

The PA230 probe was previously cleared

via K040596 & 071996
[1]	Small Organs includes Breast, Thyroid and Testicles
[2]	Cardiac is Adult and Pediatric
[3]	Combined modes are: B + M + PW + CW + CFM + PD
[4]	CMM
[5]	MView
[6]	3D
[7]	4D
[8]	VPan
[9]	XView
[10]	QIMT
[11]	Stress
[12]	Strain
[13]	TP View

··

Homi Ta Whang

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices
510(k) Number _________________________________________________________________________________________________________________________________________

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PA122

September 19.

	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P	6, 8, 9
Small Organ [1]
Neonatal Cephalic	P	P	P	P	P	P	P		P	6, 8, 9
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	P	P	4, 6, 8, 9, 11,12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P	6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)
The PA122 probe was previouslycleared via K040596
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	N	N	N	N	N	N	N		N	5, 6, 8, 9, 13
Small Organ [1]	N	N	N	N	N	N	N		N	4, 5, 6, 8, 9, 1
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N	N		N	5, 6, 8, 9, 10,12, 13
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)	N	N	N	N	N	N	N		N	4, 5, 6, 8, 9,
Musculo-skeletal Superficial(including Nerve Blocking)	N	N	N	N	N	N	N		N	4, 5, 6, 8, 9,
Other (Urological)
The LA332 probe to be cleared viathis submission
	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	5, 6, 8, 9, 13
Small Organ [1]	P	P	P		P	P	P		P	4, 5, 6, 8, 9, 13
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	5, 6, 8, 9, 10,12, 13
Laparoscopic	P	P	P		P	P	P		P	4, 5, 6, 8, 9, 13
Musculo-skeletal Conventional(including Nerve Blocking)	P	P	P		P	P	P		P	4, 5, 6, 8, 9, 13
Musculo-skeletal Superficial(including Nerve Blocking)	P	P	P		P	P	P		P	4, 5, 6, 8, 9, 13
Other (Urological)
	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhacementImaging (TEI)	Other (specify)
Ophthalmic
Fetal	N	N	N		N	N	N		N	5, 6, 8, 9, 10
Abdominal	N	N	N		N	N	N		N	5, 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	N	N	N		N	N	N		N	5, 6, 8, 9
Small Organ [1]
Neonatal Cephalic	N	N	N		N	N	N		N	5, 6, 8, 9
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N		N	N	N		N	5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)
The C5-2 is to be cleared via thissubmission
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhacementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	5, 6, 8, 9
Small Organ [1]	P	P	P		P	P	P		P	4, 5, 6, 8, 9
Neonatal Cephalic	P	P	P		P	P	P		P	5, 6, 8, 9
Adult Cephalic
Cardiac [2]	P	P	P		P	P	P		P	4, 5, 6, 8, 9
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	5, 6, 8, 9, 12
scopic
Musculo-skeletal Conventional(including Nerve Blocking)	P	P	P		P	P	P		P	4, 5, 6, 8, 9
Musculo-skeletal Superficial(including Nerve Blocking)	P	P	P		P	P	P		P	4, 5, 6, 8, 9
Other (Urological)

Division Sign-(fn)

. '

の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 1

. . . . .

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[11]
[13]
[13]

. .

Stress
Strain TP View

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices K081794 510(k) Number ________________________________________________________________________________________________________________________________________________________________

・・

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Arrai M. Witz

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

: .

. ----

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(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices Radiological Devices KO81794

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[2]	Cardiac is Adult and Pediatric
[3]	Combined modes are: B + M + PW + CFM + PD
[4]	CMM
[5]	MView
[6]	3D
[7]	4D
[8]	VPan
[9]	XView
[10]	QIMT
[11]	Stress
[12]	Strain
[13]	TP View

Jorg In Whing
(Division Sign-Off)

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

CA531

	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal	N	N	N		N	N	N		N	5, 6, 8, 9, 10
Abdominal	N	N	N		N	N	N		N	5, 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	N	N	N		N	N	N		N	5, 6, 8, 9
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac (2)
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N		N	N	N		N	5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional (includingNerve Blocking)	N	N	N		N	N	N		N	4, 5, 6, 8, 9
Musculo-skeletal Superficial (includingNerve Blocking)	N	N	N		N	N	N		N	4, 5, 6, 8, 9
Other (Urological)	N	N	N		N	N	N		N	5, 6, 8, 9
The CA531 probe is to be cleared via thissubmission
[1]	Small Organs includes Breast, Thyroid and Testicles
[2]	Cardiac is Adult and Pediatric
[3]	Combined modes are: B + M + PW + CFM + PD
[4]	CMM
[5]	MView
[6]	3D
[7]	4D
[8]	VPan
[9]	XView
[10]	QIMT
[11]	Stress
[12]	Strain

Strain
TP View

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number 144

· .

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CA631

ାରା

(7)

ত্ৰ ত্ৰ

[10]

[11]

[12]
[13]

VPan XView

QIMT

Stress

Strain TP View

、

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal	N	N	N		N	N	N		N	5, 6, 8, 9, 10
Abdominal	N	N	N		N	N	N		N	5, 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	N	N	N		N	N	N		N	5, 6, 8, 9
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N		N	N	N	.	N	5, 6, 8, 9, 1
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)	N	N	N		N	N	N		N	4, 5, 6, 8, 9
Musculo-skeletal Superficial(including Nerve Blocking)	N	N	N		N	N	N		N	4, 5, 6, 8, 9
Other (Urological)	N	N	N		N	N	N		N	5, 6, 8, 9
The CA631 probe is to be cleared viathis submission
	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]				P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)
The 2CW probe was previouslycleared via K982444 & 052805
[1]	Small Organs includes Breast, Thyroid and Testicles
[2]	Cardiac is Adult and Pediatric
[3]	Combined modes are:
[4]	CMM
[5]	MView
[6]	3D
[7]	4D
[8]	VPan
[9]	XView
[10]	QIMT
[11]	Stress
[12]	Strain
[13]	TV View
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [3]	TVM	Tissue Enhacement Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional (including Nerve Blocking)
Musculo-skeletal Superficial (including Nerve Blocking)
Other (Urological)
	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhacementImaging (TEI)	Other (specify)
Ophthalmic
Fetal	N	N	N		N	N	N		N	5, 6, 8, 9, 10
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	N	N	N		N	N	N		N	5, 6, 8, 9
Transvaginal	N	N	N		N	N	N		N	5, 6, 8, 9
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)	N	N	N		N	N	N		N	5, 6, 8, 9
The EC1123 probe is to be cleared viathis submission
[1]
[2]	Cardiac is Adult and Pediatric
[3]	Combined modes are: B + M + PW + CFM + PD
[4]	CMM
[5]	MView
[6]	3D
[7]	4D
[8]	VPan
[9]	XView
[10]	QIMT
[11]	Stress
[12]	Strain
[13]	TP View
	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	Tissue EnhacementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	N	N	N	N	N	N	N		N	5, 6, 8, 9, 13
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)	N	N	N	N	N	N	N		N	5, 6, 8, 9, 13
	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhacementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)	P	P	P	P	P	P	P	P	P	4, 6, 9, 11, 13
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)
	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhacementImaging (TEI)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)	P	P	P	P	P	P	P	P	P	4, 6, 9, 11, 12
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)
	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P	5, 6, 8, 9, 13
Intraoperative (Abdominal)	P	P	P		P	P	P		P	5, 6, 8, 9, 13
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	5, 6, 8, 9, 13
Small Organ [1]	P	P	P		P	P	P		P	4, 5, 6, 8, 9, 13
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	5, 6, 8, 9, 12, 13
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)	P	P	P		P	P	P		P	4, 5, 6, 8, 9, 13
Musculo-skeletal Superficial(including Nerve Blocking)	P	P	P		P	P	P		P	4, 5, 6, 8, 9, 13
Other (Urological)
	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhacementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P	5, 6, 8, 9, 13
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic	P	P	P			P	P		P	5, 6, 8, 9, 13
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)
The LP323 probe was previouslycleared via K051837
[1][2][3][4][5][6][7][8][9][10][11][12][13]	Small Organs includes Breast, Thyroid and TesticlesCardiac is Adult and PediatricCombined modes are: B + M + PW + CFM + PDCMMMView3D4DVPanXViewQIMTStressStrainTP View
Clinical Application	Mode of Operations
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhacementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac (2)	P	P	P	P	P	P	P	P	P	4, 6, 7, 8, 9, 11,12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)
The BS230 probe was previouslycleared via K060827
[1]	Small Organs includes Breast, Thyroid and Testicles
[2]	Cardiac is Adult and Pediatric
[3]	Combined modes are: B + M + PW + CW + CFM + PD
[4]	CMM
[5]	MView
[6]	3D
[7]	4D
[8]	VPan
[9]	XView
[10]	QIMT
[11]	Stress
[12]	Strain
[13]	TP View
Clinical Application		Mode of Operations
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhacementImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P		P	5, 6, 7, 8, 9, 10
Abdominal	P	P	P		P	P	P		P	5,6,7,8,9
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac (2)
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	5, 6, 7, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)
The BC431 probe was previouslycleared via K060827
[1]
[2]	Small Organs Includes Breast, Thyroid and TesticlesCardiac is Adult and Pediatric
[3]					Combined modes are: B + M + PW + CFM + PD
[4]	CMM
[5]	MView
[6]	3D
[7]	4D
[8]	VPan
[9]	XView
[10]	QIMT
[11]	Stress

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices Hadlorogical Devices K081794

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: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

11:10 PM IST

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・

Lopri Thithen

(Division Sign-On) ర్ Division of Reproductive, Abdominal and
Radiological Devices Radiological Devices
510(k) Number ___________________________________________________________________________________________________________________________________________

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

1 :

September 1978 - 1978 - 1992

Aoguth Wz
(Division Sign-Off)

: 上

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

EC1123

Aori M. Whey

(Division Sigh-Off) Division of Reproductive, Abdominal and Radiological Devices K081794 510(k) Number ________________________________________________________________________________________________________________________________________________________________

1 - 1 - 1 - 1 - 1 - 1 -

10(k) Number

and the comments of the count

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

1 .

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

Lornell Da Witz

のお気になる。

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices KOSIT94 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

Arga In Wtz

(Division Sign-Off) Division of Reproductive, Abdominal and
Radiological Devices K081794 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

Anna hrz

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K081794 510(k) Number ________________________________________________________________________________________________________________________________________________________________

1 :

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

[8] [9]

[10] [1]

[12]

[13]

XView
QIMT

Stress

Strain

TP View

_
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 94 K0817 510 (k) Number _______________________________________________________________________________________________________________________________________________________________

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: 1

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(Division Sign Off)

Division of Reproductive, Abdominal and 510(k) Number __

. .

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

ﮨﮯ۔

(Division Sign-Off)

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

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

### BC431

រេជ្យ
ព្រះពុ

.

.

:

.

Stress
Strain
TP View

·

Division of Reproductive, Abdominal and Radiological Devices 8/794 510(k) Number __

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.