Who is the manufacturer of NEMIO XG, SAA-580A?

Toshiba America Medical Systems, In.C filed the 510(k) submission for NEMIO XG, SAA-580A (K061605).

What is the FDA product code for NEMIO XG, SAA-580A?

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

What is the regulatory pathway for NEMIO XG, SAA-580A?

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

What are the predicate devices for NEMIO XG, SAA-580A?

SSA-550A/NEMIO Diagnostic Ultrasound System (K010631).

Who can help prepare an FDA 510(k) submission like NEMIO XG, SAA-580A?

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.

NEMIO XG, SAA-580A

K061605 · Toshiba America Medical Systems, In.C · IYN · Jun 22, 2006 · Radiology

Device Facts

Record ID	K061605
Device Name	NEMIO XG, SAA-580A
Applicant	Toshiba America Medical Systems, In.C
Product Code	IYN · Radiology
Decision Date	Jun 22, 2006
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

Intended Use

The Nemio XG system is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial)..

Device Story

Nemio XG (SSA-580A) is a mobile diagnostic ultrasound system. It processes ultrasonic echoes and Doppler signals captured by various probes (2-12 MHz frequency range: linear, convex, sector arrays). The system transforms these inputs into B-mode, M-mode, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), Color Doppler, Amplitude Doppler, Color Velocity Imaging, and Harmonic Imaging outputs. Used in clinical settings by healthcare professionals for diagnostic visualization. Output is displayed on the system monitor for real-time clinical assessment, aiding in diagnosis across multiple anatomical regions. Benefits include non-invasive diagnostic imaging for various patient populations.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness supported by engineering assessments and compliance with international ultrasound safety standards (IEC 60601, IEC 60601-2-37).

Technological Characteristics

Mobile ultrasound system; frequency range 2-12 MHz. Probes: flat linear, convex linear, sector arrays. Modes: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity, Harmonic Imaging, B-TDI, M-TDI. Complies with IEC 60601 and IEC 60601-2-37. Track 3 device.

Indications for Use

Indicated for diagnostic ultrasound imaging in fetal, abdominal, intraoperative, pediatric, small organ, neonatal/adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vascular, and musculoskeletal (conventional/superficial) applications. Prescription use only.

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

SSA-550A/NEMIO Diagnostic Ultrasound System (K010631)

Related Devices

K043078 — NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A · Toshiba America Medical Systems, In.C · Nov 17, 2004
K063130 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 · Toshibamedical Systems Corporation · Nov 2, 2006
K082119 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0 · Toshiba America Medical Systems, In.C · Aug 12, 2008
K091295 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 · Toshiba America Medical Systems, In.C · May 15, 2009
K050380 — XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A · Toshiba America Medical Systems, In.C · Feb 23, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ JUN 2 2 2006 #### 510(k) Summary of Safety and Effectiveness: 21 CFR 807.92 | Submitter's Name: | Toshiba America Medical Systems, Inc. | |--------------------------|--------------------------------------------------------------------------------------| | Address: | P.O. Box 2068,2441 Michelle Drive Tustin, CA 92781-206 | | Contact: | Paul Biggins, Regulatory Affairs Specialist | | Telephone No.: | (714) 730-5000 | | Device Proprietary Name: | Nemio XG, SSA-580A | | Common Name: | Ultrasound Imaging System | | Classification: | | | Regulatory Class: | II | | Review Category: | Tier II | | | Ultrasonic Pulsed Doppler Imaging System - Procode: 90-IYN [Fed.Reg.No.:892.1550] | | | Ultrasonic Pulsed Echo Imaging System - Procode: 90-IYO [Fed.Reg.No.:892.1560] | | | Diagnostic Ultrasonic Transducer - Procode: 90-ITX | [Fed. Reg. No .: 892.1570] #### Identification of Predicate Devices: Toshiba America Medical Systems believes that this device is substantially equivalent to the Following device; SSA-550A/NEMIO Diagnostic Ultrasound System, 510(k) control number K010631. ### Device Description: The Nemio XG will be offered in one variation which is a mobile system. It is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz. #### Intended Use: The Nemio XG system is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial).. ### Safety Considerations: The device is designed and manufactured in conjunction with the Quality System Regulation, IEC- 60601 (applicable portions), and IEC 60601-2-37. international standard for ultrasound safety. This unit is similar to that of the Toshiba SSA-550A/NEMIO and engineering assessments identify no new issues of risk or safety. {1}------------------------------------------------ Image /page/1/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 a staff with two snakes entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 222 2006 Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 Re: K061605 Trade Name: NEMIO XG SSA-580A Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation 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: June 6, 2006 Received: June 9, 2006 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 NEMIO XG SSA-580A Diagnostic Ultrasound System as described in your premarket notification: Image /page/1/Picture/11 description: The image is a circular logo with the letters "FDA" in a stylized font at the center. Above the letters, the text "THE THE" is arranged in an arc. Below the letters, the word "Centennial" is written in a cursive font. The entire logo is surrounded by a dotted circle, with additional text following the curve of the circle. The text is difficult to read due to the image quality. oling Public . I {2}------------------------------------------------ ### Transducer Model Number | PLM-703AT | |-----------| | PC-19M | | PSM-20CT | | PSM-30BT | | PEF-510MB | | PVM-651VT | | PSM-375AT | | PLM-1202S | | PVM-740RT | 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 {3}------------------------------------------------ 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 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 Ralph Shuping at (301) 594-1212. Sincerely yours. Daniel A. Segrem for Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure(s) {4}------------------------------------------------ ### Diagnostic Ultrasound Indications for Use Form System _X Transducer Model Nemio XG, SSA-580A 510(k) Number(s) K\$\phi\$61 6\$\beta\$S Mode of Operation PWD CWD Amplitude B M Color Color A Combined Harmonic Clinical Application Doppler Doppler Velocity (Specify) Imaging Imaging Ophthalmic N N Z N Fetal N N N N ત્ત્વ N N N N N N Abdominal N N પ N N Intraoperative (Specify) N N N N N N Intraoperative Neurological Pediatric N N N N N N N N N Small Organ (Specify) N N N N N N N N N N N N N Neonatal Cephalic N N N N N N Adult Cephalic N N N N N N N N N N N N N Cardiac N N N N N N N N N N N Transesophagea! N N N N N N N N N Transrectal N N N N N N N N Transvaginal Transurethral Intravascular N N N N Peripheral Vascular N N N N Laparoscopic Musculo-skeletal Superficial N N N N N N N N N N N N N Musculo-skeletal N N N Conventional N N N N N N N Endoscopic Other (specify) N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF) Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; B-TDI; M-TDI > RI EASE DO NOT VIRTIE REI OW THIS LINE. CONTINUE ON OTHER RAGES IC Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Daniel B. Ingram 11 {5}------------------------------------------------ DUCER TABLE Kp616ø2 Transducer Model Number: PLM-703AT 510(k) Control Number: | | | Mode of Operation | | | | | | | | | |------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (Specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (Specify) | | P | P | P | | P | P | P | P | P | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | P | P | P | | P | P | P | P | P | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Superficial | | P | P | P | | P | P | P | P | P | | Musculo-skeletal | | P | P | P | | P | P | P | P | P | | Conventional | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF) Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; B-TDI; M-TDI Previous 510(k) control # k010361 Concurrence of CDRHI, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Eavid H. Legman (Division Sign-Off) Division of Reproductive, At ാൻ Radiological Devices != 10(k) Number 12 {6}------------------------------------------------ Transducer Model Number: PC-19M 510(k) Control Number: Kp616ø5 | | | Mode of Operation | | | | | | | | | |----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (Specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | P | | | | | | | Small Organ (Specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | P | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N= new indication: P = Previously Cleared by FDA = E = Added under Appendix 8 (510(k) N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF) Additional Comments: Previous 510(k) control # k010361 EDO Concurrence of CDRH, Office of Device Eve David A. Hanson (Division Sign-Off) Division of Reproductive and Radiological Devices 510(k) Number Prescription Use (Per 21 CFR 801.109) 13 {7}------------------------------------------------ Transducer Model Number: PSM-20CT 510(k) Control Number: Kg616øS | | | Mode of Operation | | | | | | | | | | |----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|--| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | | | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | Abdominal | | | | | | | | | | | | | Intraoperative (Specify) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | | | | Neonatal Cephalic | | P | P | P | P | P | P | P | P | P | | | Adult Cephalic | | P | P | P | P | P | P | P | P | P | | | Cardiac | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF) | Additional Comments: | TDI; M-TDI | |----------------------|----------------------------------| | Combined Modes: | B/M; B/PWD; BDF/PWD; BDF/MDF; B- | Previous 510(k) control # k010361 Previous 510(k) Control # k01036 1 (Previous Province of CDRH, Office of Device of Device Evaluation (ODE) Concurrence of CDRH, Office of DRH, Office of Device Evaluation (OD David h. Ayerson (Division Sign-Off) Division of Reproductive, Abe and Radiological Devices 510(k) Number Prescription Use (Per 21 CFR 801.109) {8}------------------------------------------------ Transducer Model Number: PSM-30BT 510(k) Control Number: Kp614øS | Clinical Application | Mode of Operation | | | | | | | | | | |------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------| | | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | E | E | E | E | E | E | E | E | E | | Intraoperative (Specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | E | E | E | E | E | E | E | E | E | | Small Organ (Specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | E | E | E | E | E | E | E | E | E | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | Conventional | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | | | | | | | | | | | | N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF) Additional Comments: _________________________________________________________________________________________________________________________________________________________ Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; B-TDI; M-TDI Added under appendix E to 510(k) control # k010361 ow This Ling CONTINUE ON OTHE TE DO NOT WATE BEL Concurrence of CDRH, Office of Device Evaluation David A. Hanson (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices >10(k) Number _ Prescription Use (Per 21 CFR 801.109) {9}------------------------------------------------ Transducer Model Number: PEF-510MB 510(k) Control Number: | K461605 | |---------| |---------| | | | | Mode of Operation | | | | | | | | |------------------------------|---|---|-------------------|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (Specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | P | P | P | P | P | P | P | P | P | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | Conventional | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF) Additional Comments: ______________________________________________________________________________________________________________________________________________________ TDI; M-TDI ___________________________________________________________________________________________________________________________________________________________________ Previous 510(k) control # k010361 Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Leggett (Division Sign-Off) Division of Reproductive, Abdominal, And Radiological Devices K Number K0610 Prescription Use (Per 21 CFR 801.109) .. ... 14.00 {10}------------------------------------------------ 11661609 Transducer Model Number: PVM-651VT 510(k) Control Number: | | | Mode of Operation | | | | | | | | | |------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (Specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | P | P | P | | P | P | P | P | P | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | Conventional | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | | | | | | | | | | | | N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF) Additional Comments: _________________________________________________________________________________________________________________________________________________________ Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; B-TDI; M-TDI Previous 510(k) control # k010361 C SE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTHER PAGES IF ACEDED Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Seymann (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109) {11}------------------------------------------------ Transducer Model Number: PSM-375AT 510(k) Control Number: Kd616b5 | | | Mode of Operation | | | | | | | | | |------------------------------------------------------------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | | Ophthalmic | | | | | | | | | | | | Fetal | | P | P | P | | P | P | P | P | P | | Abdominal | | P | P | P | | P | P | P | P | P | | Intraoperative (Specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | P | P | P | | P | P | P | P | P | | Small Organ (Specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | Conventional | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF) | | | | | | | | | | | | Additional Comments: | TDI; M-TDI | |----------------------|----------------------------------| | Combined Modes: | B/M; B/PWD; BDF/PWD; BDF/MDF; B- | Previous 510(k) control # k010361 Previous 510(k) control # k01036 1 Previous S10(k) Concurrence of CDRH, Office of Device Evaluation (ODE) David h. Sypon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K06160 Prescription Use (Per 21 CFR 801.109) ... {12}------------------------------------------------ Transducer Model Number: PLM-1202S 510(k) Control Number: | / 124 ાજ | 0 | વિત્ત 1 | |----------------|---|------------| |----------------|---|------------| | | Mode of Operation | | | | | | | | | | |------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative | | P | P | P | | P | P | P | P | P | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (Specify) | | P | P | P | | P | P | P | P | P | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | P | P | P | | P | P | P | P | P | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Superficial | | P | P | P | | P | P | P | P | P | | Musculo-skeletal | | P | P | P | | P | P | P | P | P | | Conventional | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF) Previously Cleared by FDA; E dication; } e Added under Appendix E (L Additional Comments: _________________________________________________________________________________________________________________________________________________________ Combined Modes: B/M; B/EWD; BDF/EWD; BDF/MDF; B-TDI; M-TDI Previous 510(k) control # k010361 Previous 510(k) control # k010361 (ELLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER EAGES IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) David R. Leggett (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices . 04:10 Number - --------- Prescription Use (per 21 CFR 801.109) . {13}------------------------------------------------ Transducer Model Number: PVM-740RT 510(k) Control Number: ER TABLE Kf616ф5 | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | |-------------------------------|---|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|------------------| | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | P | P | P | | P | P | P | P | P | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF) Combined Modes: B/M; B/EWD; BDF/EWD; BDF/MDF; B-Additional Comments: TDI; M-TDI Previous 510(k) control # k010361 (ELEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER Concurrence of CDRH, Office of Device Evaluation (ODE) David Ch. Wegman (Division Sign-Off) Amsion of Reproductive, Abdomina " Dadiological Devices : 99kj Number Prescription Use (per 21 CFR 801.109)