Who is the manufacturer of MODEL 7340 ULTRASOUND SYSTEM?

Esaote, S.p.A. filed the 510(k) submission for MODEL 7340 ULTRASOUND SYSTEM (K081794).

What is the FDA product code for MODEL 7340 ULTRASOUND SYSTEM?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for MODEL 7340 ULTRASOUND SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MODEL 7340 ULTRASOUND SYSTEM?

7300 (MyLab30) (K040596, K052805 & K060827); 6100 (MyLab90) (K051837 & K060827).

Who can help prepare an FDA 510(k) submission like MODEL 7340 ULTRASOUND SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MODEL 7340 ULTRASOUND SYSTEM

K081794 · Esaote, S.p.A. · IYN · Jul 10, 2008 · Radiology

Device Facts

Record ID	K081794
Device Name	MODEL 7340 ULTRASOUND SYSTEM
Applicant	Esaote, S.p.A.
Product Code	IYN · Radiology
Decision Date	Jul 10, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

Intended Use

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 Story

Portable ultrasound system for diagnostic general studies; inputs include signals from phased, convex, linear array, Doppler, and BiScan probes. Operates in B-Mode, M-Mode, MView, Doppler, Color Flow Mapping, Amplitude Doppler, Tissue Velocity Mapping, and Tissue Enhancement Imaging. Features LCD display, alphanumeric keyboard for data entry/annotation, internal hard disk, and DVD-RW for storage. Connectivity via LAN/USB for external archiving. Used in clinical settings by physicians/technicians. Provides real-time imaging for biopsy guidance and needle/catheter placement; aids clinical decision-making through visualization of anatomical structures and vascular access.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological comparison, performance specifications, and adherence to recognized safety standards for diagnostic ultrasound systems.

Technological Characteristics

Portable ultrasound system (approx. 11 kg); LCD display (SVGA); internal Li-ion battery. Supports phased, convex, linear, Doppler, and BiScan probes. Imaging frequencies 2.5-18 MHz. Connectivity: LAN, USB, DICOM (Media Storage, Storage SCU, Worklist, MPPS, Storage Commitment, Print). Safety: IEC60601-1, Track 3 acoustic output display. Advanced tools: 3D/4D, VPan, Stress Echo, Strain/Strain Rate analysis, Intima-Media Thickness.

Indications for Use

Indicated for diagnostic ultrasound imaging in cardiac, vascular, abdominal, fetal, pediatric, neonatal/adult cephalic, small organ, musculoskeletal, urological, transvaginal, transrectal, laparoscopic, and intraoperative applications. Includes biopsy guidance and needle/catheter placement assistance.

Regulatory Classification

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.

Predicate Devices

7300 (MyLab30) (K040596, K052805 & K060827)
6100 (MyLab90) (K051837 & K060827)

Reference Devices

Acuson P10 (K063761)

Related Devices

K142077 — MYLABGAMMA · Esaote, S.p.A. · Sep 12, 2014
K040596 — ULTRASOUND IMAGING SYSTEM, MODEL 7300 · Esaote, S.p.A. · Mar 31, 2004
K121983 — DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA · Benq Medical Technology Corpation · Sep 7, 2012
K220993 — Ultrasound System SONIMAGE MX1 · Konica Minolta, Inc. · Jun 23, 2022
K142714 — S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System · Sonoscape Company Limited · Jan 29, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ 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. | {1}------------------------------------------------ ### 807.92 (a)(4) ### 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. #### 807.92(a)(5) ### Intended Use(s) 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. 8 {2}------------------------------------------------ # 807,92(a)(6) 1 1 # Technological Characteristics | | 7340 (This submission) | 7300 (K040596, K052805 and K060827) | 6100 (K051837 and K060827) | Acuson P10 (K063761) | |-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------| | Electrical Safety | IEC60601-1 | IEC60601-1 | IEC60601-1 | EN60601-1 | | Ultrasound Safety | Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) | Unknown | | Indication for Use | | | | | | • Cardiac | YES | YES | YES | YES | | • Transesophageal Cardiac | 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, Amplitude Doppler, TEI, TVM | 2D, M-Mode, MView, PW, CW, CFM, Amplitude Doppler, 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/Doppler Frequencies | 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 (This submission) | 7300 (K040596, K052805 and K060827) | 6100 (K051837 and K060827) | Acuson P10 (K063761) | | | | | | | | | Transrectal, Transvaginal, Intraoperative | Transrectal, Transvaginal, Intraoperative | Transrectal, Transvaginal Intraoperative | | | • Biopsy Line Depth marker | 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 Archival Capabilities | YES | YES | YES | Unknown | | DICOM Classes: Media Storage, Storage SCU, Worklist, MPPS and Storage Commitment, Print | YES | YES | Media Storage, Storage SCU | Unknown | | VCR / Page Printer | YES | YES | YES | Unknown | | M&A Capabilities | Cardiac, Vascular, Urological, Gynaecological, OB and general purpose measurements | Cardiac, Vascular, Urological, Gynaecological,OB and general purpose measurements | Cardiac, Vascular, OB and general purpose measurements | Unknown | | Advanced Tools | 3D/4D, VPan, Stress Echo, Strain and Strain Rate analysis, Intima-Media Thickness | 3D/4D, VPan, Stress Echo, Strain and Strain Rate analysis, Intima-Media Thickness | 3D/4D, Stress Echo, Strain and Strain Rate analysis, Intima-Media Thickness | Unknown | | Weight | portable: about 11 kg with battery installed with trolley: 46 kg | portable: 10 kg with trolley: 40 kg | 120 kg | Unknown | | Dimensions | portable position: 38.2 (w) x 16.5 (h) x 49 (d) cm use position: 38.2 (w) x 43 (h) x 49 (d) cm with trolley: 50 (w) x 133 (h) x 51 (d) cm | portable position: 35.5 (w) x 14 (h) x 49 (d) cm use position: 35.5 (w) x 41 (h) x 49 (d) cm with trolley: 50 (w) x 130 (h) x 51 (d) cm | 60(w) x 160 (h) x 120(d) cm | 54mm (h) x 97mm (w) x 137mm (l) | | Internal Lithium Ion Battery | Yes | No | No | Yes | {3}------------------------------------------------ {4}------------------------------------------------ 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 | {5}------------------------------------------------ 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 {6}------------------------------------------------ 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) {7}------------------------------------------------ ## Indications for Use 510(k) Number (if known): Device Name: 7340 Ultrasound System 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. 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 {8}------------------------------------------------ ### Mod.7340 | Clinical Application | Mode of Operations | | | | | | | | | | |-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|----------------------------------------|------------------------------| | | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [3] | TVM | Tissue Enhancement Imaging (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 -- . . . . . {9}------------------------------------------------ | | Mode of Operations | | | | | | | | | | |-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|---------------------------------------|-----------------------| | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [3] | TVM | Tissue Enhacement Imaging (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 (including Nerve 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 _________________________________________________________________________________________________________________________________________ . . . · {10}------------------------------------------------ ### PA122 : 1. September 19. . | | Mode of Operations | | | | | | | | | | |-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|----------------------------------------|---------------------------| | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [3] | TVM | Tissue Enhancement Imaging (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 previously cleared via K040596 | | | | | | | | | | | | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [3] | TVM | Tissue Enhancement Imaging (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 via this submission | | | | | | | | | | | | | Mode of Operations | | | | | | | | | | | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [3] | TVM | Tissue Enhancement Imaging (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 | Color Doppler | Amplitude Doppler | Combined [3] | TVM | Tissue Enhacement Imaging (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 this submission | | | | | | | | | | | | 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 | 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) . ' (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ___________________________________________________________________________________________________________________________________________ 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 . . . . . {11}------------------------------------------------ [11] [13] [13] . . Stress Strain TP View (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K081794 510(k) Number ________________________________________________________________________________________________________________________________________________________________ ・・ {12}------------------------------------------------ Arrai M. Witz (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number . : . . ---- {13}------------------------------------------------ ![]() (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices Radiological Devices KO81794 {14}------------------------------------------------ | [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) Division of Reproductive, Abdominal and Radiological Devices K081794 510(k) Number _______________________________________________________________________________________________________________________________________________________________ {15}------------------------------------------------ ### CA531 | | Mode of Operations | | | | | | | | | | |-------------------------------------------------------------|-----------------------------------------------------|---|-----|-----|------------------|----------------------|-----------------|-----|----------------------------------------|-----------------| | Clinical Application | B | M | PWD…