Who is the manufacturer of MYLAB 70 ULTRASOUND IMAGING SYSTEM?

Esaote, S.p.A. filed the 510(k) submission for MYLAB 70 ULTRASOUND IMAGING SYSTEM (K051308).

What is the FDA product code for MYLAB 70 ULTRASOUND IMAGING 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 MYLAB 70 ULTRASOUND IMAGING SYSTEM?

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

What are the predicate devices for MYLAB 70 ULTRASOUND IMAGING SYSTEM?

7250 Ultrasound Imaging System (K982444); 7250 Ultrasound Imaging System (K994369); 7350 Ultrasound Imaging System (K050326); Technos Ultrasound Imaging System (K014168); Technos Ultrasound Imaging System (K023255).

Who can help prepare an FDA 510(k) submission like MYLAB 70 ULTRASOUND IMAGING 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.

MYLAB 70 ULTRASOUND IMAGING SYSTEM

K051308 · Esaote, S.p.A. · IYN · Jun 1, 2005 · Radiology

Device Facts

Record ID	K051308
Device Name	MYLAB 70 ULTRASOUND IMAGING SYSTEM
Applicant	Esaote, S.p.A.
Product Code	IYN · Radiology
Decision Date	Jun 1, 2005
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended Use

Esaote's MyLab70 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Adult Cephalic, Pediatric and Other: Urologic.

Device Story

MyLab70 is a mainframe ultrasound imaging system for diagnostic general studies. It accepts inputs from phased, convex, linear array, and Doppler probes. The system processes these signals to generate images in B-Mode, M-Mode, Doppler, Color Flow Mapping, and Tissue Enhancement Imaging (TEI). It features Tissue Velocity Mapping (TVM) and VPAN. The system includes a CRT color display, alphanumeric keyboard for data entry, and DVD-RW for storage. It connects to PCs via LAN and supports peripherals like video recorders and printers. Used in clinical settings by healthcare professionals, the system aids in diagnostic decision-making by providing real-time visualization of internal structures and blood flow. Patient benefits include non-invasive diagnostic assessment across various clinical applications.

Clinical Evidence

Bench testing only. The device underwent electrical safety testing per IEC60601-1 and acoustic output measurements per Track 3 requirements. No clinical data was required or provided for this 510(k) submission.

Technological Characteristics

Mainframe ultrasound system; CRT display (SVGA); supports phased, convex, linear, and Doppler probes. Modes: 2D, M-Mode, PW, CW, CFM, PD, TEI, TVM, VPAN. Connectivity: LAN port, DVD-RW. Electrical safety: IEC60601-1. Acoustic output: Track 3. Weight: 110 kg. Dimensions: 60 x 160 x 90 cm.

Indications for Use

Indicated for diagnostic ultrasound imaging in patients requiring Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal, Abdominal, Fetal, Transvaginal, Transrectal, Adult Cephalic, Pediatric, and Urologic examinations.

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

7250 Ultrasound Imaging System (K982444)
7250 Ultrasound Imaging System (K994369)
7350 Ultrasound Imaging System (K050326)
Technos Ultrasound Imaging System (K014168)
Technos Ultrasound Imaging System (K023255)

Related Devices

K051837 — MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 · Esaote, S.p.A. · Jul 20, 2005
K052805 — MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150 · Esaote, S.p.A. · Oct 17, 2005
K050326 — 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 · Esaote, S.p.A. · Feb 28, 2005
K070903 — MYLAB40 · Esaote Europe B.V. · Jul 2, 2007
K040596 — ULTRASOUND IMAGING SYSTEM, MODEL 7300 · Esaote, S.p.A. · Mar 31, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ K051388 510(k) Summary MyLab70 Ultrasound Imaging System Esaote, S.p.A. JUN 1 - 2005 # 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, Official Correspondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250 Phone: (317) 849-1916 x103 Facsimile: (317) 577-9070 | Contact Person: | Carri Graham | | |-------------------------|----------------------------------------------------------------------------------------------------|---------| | Date: | May 16, 2005 | | | 807.92(a)(2) | | | | Trade Name: | (6150) MyLab70 Ultrasound Imaging 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) | | | | Esaote, S.p.A. | 7250 Ultrasound Imaging System | K982444 | | Esaote, S.p.A. | 7250 Ultrasound Imaging System | K994369 | | Esaote, S.p.A. | 7350 Ultrasound Imaging System | K050326 | | Esaote, S.p.A. | Technos Ultrasound Imaging System | K014168 | | Esaote, S.p.A. | Technos Ultrasound Imaging System | K023255 | {1}------------------------------------------------ 510(k) Summarv MyLab70 Ultrasound Imaging System Esaote, S.p.A. ### 807.92 (a)(4) ### Device Description The MyLab 70 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The MyLab70 is equipped with a CRT Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The MyLab70 can drive phased (PA), convex (CA), linear array (LA) and Doppler probes. The MyLab70 is equipped with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to a Personal Computer via a LAN port. Optional accessory devices available for the MyLab70 include a S-VHS video recorder and a monochrome or color page printer. The MyLab70 is equipped with an isolation transformer to adequately insulate the system's peripherals. 807.92(a)(5) ### Intended Use(s) Esaote's MyLab70 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Adult Cephalic, Pediatric and Other: Urologic. {2}------------------------------------------------ 510(k) Summary MyLab70 Ultrasound Imaging System Esaote, S.p.A. ## 807.92(a)(6) ## Technological Characteristics | | MyLab 70 | Technos | 7350 MyLab 50 | |---------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------| | | this submission | (K014168 & K023255) | (K050326) | | Electrical Safety | IEC60601-1 | IEC60601-1 | IEC60601-1 | | Ultrasound Safety | Track 3 (Acoustic | Track 3 (Acoustic | Track 3 (Acoustic Output | | | Output Display) | Output Display) | Display) | | Indication for Use | | | | | OB/Fetal | YES | YES | YES | | Abdominal | YES | YES | YES | | Pediatric ● | YES | YES | YES | | Small organ � | YES | YES | YES | | Neonatal Cephalic | YES | YES | YES | | Adult Cephalic | YES | YES | YES | | Cardiac � | YES | YES | YES | | Transesophageal | YES | YES | YES | | Transrectal � | YES | YES | YES | | Transvaginal | YES | YES | YES | | Peripheral Vascular � | YES | YES | YES | | Musculoskeletal | YES | YES | YES | | (conventional & superficial) | | | | | Probe Technology | | | | | Phased Array | YES | YES | YES | | Linear Array | YES | YES | YES | | Convex Array | YES | YES | YES | | Doppler Probes ● | YES | YES | YES | | Bi-Scan | YES | NO | NO | | Modes of operation | | | | | 2D, M-Mode, PW, CW, CW, CFM, | YES | YES | YES | | Amplitude Doppler (PD), TEI | | | | | CnTI | YES | YES | No | | TVM | YES | YES | YES | | VPAN | YES | YES | NO | | Imaging Frequencies | 1 =16 MHz | 1.5 =16 MHz | 2 = 10 MHz | | CFM/Doppler Frequencies | 2 =12 MHz | 2 ÷12 MHz | 2 = 8 MHz | | Tissue Velocity Mapping feature | YES | YES | YES | | Biopsy Guidance | | | | | Biopsy Intended Uses | General Purpose, | General Purpose, | General Purpose, | | | Transrectal, | Transrectal, | Transrectal, Transvaginal | | | Transvaginal | Transvaginal | | | Display type | CRT | CRT | CRT | | Display Standard | SVGA | SVGA | SVGA | | Digital Archival Capabilities | YES | YES | YES | | | MyLab 70 | Technos | 7350 MyLab 50 | | | this submission | (K014168 & K023255) | (K050326) | | DICOM Classes: | Media Storage, Storage SCU | Media Storage, Storage SCU | Media Storage, Storage SCU | | VCR / Page Printer | YES | YES | YES | | M&A Capabilities | Cardiac, Vascular, OB and general purpose measurements | Cardiac, Vascular, OB and general purpose measurements | Cardiac, Vascular, OB and general purpose measurements | | Weight | 110 kg | 140 kg | 90 kg | | Dimensions | 60(w) x 160(h) x 90(d) cm | 60(w) x 160(h) x 105(d) cm | 60(w) x 155(h) x 90(d) cm | 9 {3}------------------------------------------------ 510(k) Summary MyLab70 Ultrasound Imaging System Esaote, S.p.A. : · {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. JUN 1 - 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Esaote, S.p.A. % Ms. Carri Graham Consultant The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250 Re: K051308 Trade Name: Model 6150 (MyLab70) Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Number: 21 CFR 892.1560 Regulatory Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 16, 2005 Received: May 19, 2005 ### Dear Ms. Graham: 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 Model 6150 (MyLab70) Ultrasound Imaging System, as described in your premarket notification: ### Transducer Model Number | CA123 | CA430 | |-------|-------| | CA421 | CA621 | {5}------------------------------------------------ ### Page 2 - Ms. Graham | EC123 | PA230 | |-------|--------| | LA424 | TEE022 | | LA522 | TRT23 | | LA523 | 2CW | | LA532 | 5CW | | PA121 | BS230 | | PA122 | PA023 | 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 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 over); production over); production on itiled, . {6}------------------------------------------------ ### Page 2 - Ms. Graham "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) 638-2011 or (301) 443-6597 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 Rodrigo C. Perez at (301) 594-1212. Sincerely yours, Rate Phelps fa Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure(s) {7}------------------------------------------------ | | Mode of Operation | | | | | | | | | | | |----------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|--| | Clinical Application | A | B | M | PWD (PW) | CWD (CW) | Color Doppler (CFM) | Amplitude Doppler (PD) | Color Velocity Imaging | Combined (specify) | Other (specify) | | | Ophthalmic | | | | | | | | | | | | | Fetal | | N | N | N | N | N | N | | N (see Note 1) | N (see Note 2) | | | Abdominal | | N | N | N | N | N | N | | N (see Note 1) | N (see Note 2) | | | Intraoperative (specify) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | | N | N | N | N | N | N | | N (see Note 1) | N (see Note 2) | | | Small Organ (specify) | | N | N | N | N | N | N | | N (see Note 1) | N (see Note 2) | | | Neonatal Cephalic | | N | N | N | N | N | N | | N (see Note 1) | N (see Note 2) | | | Adult Cephalic | | N | N | N | N | N | N | | N (see Note 1) | N (see Note 2) | | | Cardiac | | N | N | N | N | N | N | | N (see Note 1) | N (see Note 2) | | | Transesophageal | | N | N | N | N | N | N | | N (see Note 1) | N (see Note 2) | | | Transrectal | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | | Transvaginal | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | | Transurethral | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vascular | | N | N | N | N | N | N | | N (see Note 1) | N (see Note 2) | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional | | N | N | N | N | N | N | | N (see Note 1) | N (see Note 2) | | | Musculo-skeletal Superficial | | N | N | N | N | N | N | | N (see Note 1) | N (see Note 2) | | | Other (Urological) | | N | N | N | N | N | N | | N (see Note 1) | N (see Note 2) | | Additional Comments: Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scleroterapy Note ( 1): Combinations: any combination of the following modes: B+M+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live. Nole (2): TEI (Tissue Enhanced Imaging) mode Bi-Scan Rati Pallys (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number *Prescription Use* {8}------------------------------------------------ | | Mode of Operation | | | | | | | | | | |-------------------------------------------------------------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD (PW) | CWD (CW) | Color Doppler (CFM) | Amplitude Doppler (PD) | Color Velocity Imaging | Combined (specify) | Other (specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Intraoperative (specify) Intraoperative Neurological | | | | | | | | | | | | Pediatric | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Small Organ (specify) | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Neonatal Cephalic | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Adult Cephalic | | | | | | | | | | | | Cardiac | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial | | | | | | | | | | | | Other | | | | | | | | | | | Additional Comments: Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scleroterapy Note ( ) : Combinations : any combination of the following modes: B+M+PW+ CFM+PD, where only one mode is live, B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live. Rat A. Pales (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number . *Prescription Use* {9}------------------------------------------------ | C 1 | | 0 | 14 14 | 4 | |--------|---|---|----------|---| | | 1 | | | | | Clinical Application | Mode of Operation | | | | | | | | | | |----------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------| | | A | B | M | PWD (PW) | CWD (CW) | Color Doppler (CFM) | Amplitude Doppler (PD) | Color Velocity Imaging | Combined (specify) | Other (specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Abdominal | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Laparoscopic | | | | | | | | | | | | Muscolo-skeletal Conventional | | | | | | | | | | | | Muscolo-skeletal Superficial | | | | | | | | | | | | Other (Urological) | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | Note (1): Combinations: any combination of the following modes: B+M+PW +CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live. Ra. A. Phillips (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 2051308 510(k) Number _ *Prescription Use* {10}------------------------------------------------ | | | | | | | Mode of Operation | | | | | |-------------------------------------------------------------------------------------|---|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD (PW) | CWD (CW) | Color Doppler (CFM) | Amplitude Doppler (PD) | Color Velocity Imaging | Combined (specify) | Other (specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Abdominal | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Intraoperative (specify) Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Laparoscopic Muscolo-skeletal Conventional Muscolo-skeletal Superficial | | | | | | | | | | | Note ( ): Combination: ary combination of the following modes: B+M+PW +CFM+PD, where only one mode is live, B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where Ra-C. Phillips (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _ Prescription Use {11}------------------------------------------------ | C 11 | A 4 | 62 | 1 | | |---------|--------|----|---|--| | | | | | | | | | | | | | Mode of Operation | | | | | |----------------------------------------------------------------------|---|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD (PW) | CWD (CW) | Color Doppler (CFM) | Amplitude Doppler (PD) | Color Velocity Imaging | Combined (specify) | Other (specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Abdominal | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Intraoperative (specify) Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Laparoscopic Musculo-skeletal Conventional Musculo-skeletal | | | | | | | | | | | | Superficial | | | | | | | | | | | | Other (Urological) | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | Note (1): Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is Ive; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live. Note (2): TEI (Tissue Enhanced Imaging) mode Note (2): TEI (Tissue Enhanced Imaging) mode Rate Phillips (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ {12}------------------------------------------------ | 1 1 | 1: | - | |--------|----|---| | | | | | | | | | | | Mode of Operation | | | | | |--------------------------------------------------|---|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD (PW) | CWD (CW) | Color Doppler (CFM) | Amplitude Doppler (PD) | Color Velocity Imaging | Combined (specify) | Other (specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Abdominal | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Transvaginal | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (Urological) | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | Note (1): Combinations: any combination of the following modes: B+M+PW +CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live. Ra-Ce Phillips (Dwision Sign-Off) Oversion of Reproductive, Abdominal, and Radiological Devices 5, "")(k) Number __ *Prescription Use* {13}------------------------------------------------ LA424 | Clinical Application | Mode of Operation | | | | | | | | | Other (specify) | | |----------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|--| | | A | B | M | PWD (PW) | CWD (CW) | Color Doppler (CFM) | Amplitude Doppler (PD) | Color Velocity Imaging | Combined (specify) | | | | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | Abdominal | | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | N | N | N | N | | N | N | | N (see Note 1) | | | | Small Organ (specify) | N | N | N | N | | N | N | | N (see Note 1) | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vascular | N | N | N | N | | N | N | | N (see Note 1) | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional | N | N | N | N | | N | N | | N (see Note 1) | | | | Musculo-skeletal Superficial | N | N | N | N | | N | N | | N (see Note 1) | | | | Other | | | | | | | | | | | | Additional Comments: Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scieroterapy Note (1): Combinations: ary combination of the following modes: B+M+PW +CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live Ra-G. Phillips (Division Sign-Off) Ovision of Reproductive, Abdominal, and Radiological Devi 510(k) Number _ Description else {14}------------------------------------------------ | Clinical Application | | Mode of Operation | | | | | | | | | | |--------------------------------------------|---|-------------------|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|--| | | A | B | M | PWD (PW) | CWD (CW) | Color Doppler (CFM) | Amplitude Doppler (PD) | Color Velocity Imaging | Combined (specify) | Other (specify) | | | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | Abdominal | | | | | | | | | | | | | Intraoperative (specify) Intraoperative | | | | | | | | | | | | | Neurological | | | | | | | | | | | | | Pediatric | | N | N | N | | N | N | | N (see Note 1) | | | | Small Organ (specify) | | N | N | N | | N | N | | N (see Note 1) | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vascular | | N | N | N | | N | N | | N (see Note 1) | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional | | N | N | N | | N | N | | N (see Note 1) | | | | Musculo-skeletal Superficial | | N | N | N | | N | N | | N (see Note 1) | | | | Other | | | | | | | | | | | | Additional Comments: Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scieroterapy Note ( ); Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live. Ra. C. Pales (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 519(k) Number __ - 1 - 5 - 5 - 5 - 5 - 5 - 5 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - {15}------------------------------------------------ |--| | | | | | Mode of Operation | | | | | | | |------------------------------------------------------------|---|---|---|-------------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD (PW) | CWD (CW) | Color Doppler (CFM) | Amplitude Doppler (PD) | Color Velocity Imaging | Combined (specify) | Other (specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (specify) Intraoperative Neurological | | | | | | | | | | | | Pediatric | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Small Organ (specify) | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Laparoscopic Musculo-skeletal | | | | | | | | | N (see | N (see | | Conventional | | N | N | N | | N | N | | Note 1) | Note 2) | | Musculo-skeletal Superficial | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | Other | | | | | | | | | | | Additional Comments: Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scieroterapy Note (1); Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live Ra. A. Phillips (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _ {16}------------------------------------------------ | Clinical Application | | | Mode of Operation | | | | | | | | | | |----------------------------------|---|---|-------------------|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|--|--| | | A | B | M | PWD (PW) | CWD (CW) | Color Doppler (CFM) | Amplitude Doppler (PD) | Color Velocity Imaging | Combined (specify) | Other (specify) | | | | Ophthalmic | | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | | Abdominal | | | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | | Pediatric | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | | | Small Organ (specify) | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | | | Neonatal Cephalic | | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | | Peripheral Vascular | | N | N | N | | N | N | | N (see Note 1) | N (see Note 2) | | | | Laparoscopic | | | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | | Other | | | | | | | | | | | | | Additional Comments: Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scleroterapy 1 Note (1); Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is ire, B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live. Ra. A. Palla (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _ {17}------------------------------------------------ | | - | | |---|---|--| | o | | | | | Mode of Operation | | | | | | | | | | |------------------------------------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD (PW) | CWD (CW) | Color Doppler (CFM) | Amplitude Doppler (PD) | Color Velocity Imaging | Combined (specify) | Other (specify) | | Ophthalmic | | | |…