(20 days)
No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound technology and safety standards.
No
The device is described as a "multi-purpose diagnostic ultrasound system" used for "imaging or fluid flow analysis" and for "clinical diagnosis purposes," which indicates a diagnostic rather than a therapeutic function.
Yes
The "Intended Use / Indications for Use" section states that the system provides "analysis packages that provide information that is used for clinical diagnosis purposes." Furthermore, the "Device Description" explicitly refers to the "Sequoia system" as a "multi-purpose diagnostic ultrasound system."
No
The device description explicitly states it is a "multi-purpose diagnostic ultrasound system with accessories and proprietary software," indicating it includes hardware components in addition to software. It also references safety standards for medical equipment, which typically apply to hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the device is a "multi-purpose diagnostic ultrasound system." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes imaging and fluid flow analysis of the human body, not analysis of samples taken from the body.
- Image Processing: The text mentions processing of received echoes to generate images, which is consistent with ultrasound imaging, not IVD testing.
Therefore, the device described is a diagnostic ultrasound system, which is a different category of medical device than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Sequoia platform is intended for use in the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX, 90-DQO
Device Description
The Sequoia system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number:
-
K032114 (July 21, 2003) cleared as ACUSON® Sequoia 8.0 Diagnostic Ultrasound . System.
The Sequoia Diagnostic Ultrasound System has been designed to conform to the following product safety standards:
- UL 2601-1, Safety Requirements for Medical Equipment .
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
- AIUMNEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic t Ultrasound
- AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 93/42/EEC Medical Device Directive .
- Safety and EMC Requirements for Medical Equipment .
- EN 60601-1 .
- EN 60601-1-1 .
- EN 60601-1-2 .
- ISO 10993 Biocompatibility ●
- The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achievable)
Mentions image processing
Processing of received echoes is performed to generate two dimensional on-screen images of anatomic structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving blood as a spectrum, or as color-coded two-dimensional images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, Musculo-skeletal (superficial and conventional), Intra-cardiac, Intra-luminal (for AcuNav transducer).
Indicated Patient Age Range
Adult, Pediatric, Neonatal, Fetal
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the text "ACUSON® Sequoia Diagnostic Ultrasound System". Above this text is the alphanumeric string "K04/319". The text appears to be part of a medical document or equipment label, possibly related to ultrasound technology.
JUN - 7 2004
SECTION 11
510(k) Summary of Safety and Effectiveness
Siemens Medical Solutions USA, Inc., Ultrasound Division has not disclosed its intent to market this device modification and requests this notification be held CONFIDENTIAL by the FDA, and not be released to any Freedom of Information request or addressed with any outside parties.
| Sponsor: | Siemens Medical Solutions USA, Inc., Ultrasound Division
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94039-7393 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Iskra Mraković
Manager of Regulatory Affairs
Telephone: (650) 694-5004
Fax: (650) 943-7053 |
| Submission Date: | May 13, 2004 |
| Device Name: | Sequoia Diagnostic Ultrasound System |
| Common Name: | Diagnostic Ultrasound System with Accessories |
| Classification: | |
Regulatory Class: II Review Category: Tier II Classification Panel: Radiology
21 CFR 892.1550
| FR # | Product Code | |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
| Diagnostic Intravascular Catheter | 870.1200 | 90-DQO |
Predicate Devices:
-
K032114 (July 21, 2003) cleared as ACUSON® Sequoia 8.0 Diagnostic Ultrasound . System.
-
K033196 (October 16, 2003) cleared as SONOLINE® Antares Diagnostic . Ultrasound System with Clarify™ VE.
1
Device Description:
The Sequoia system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number:
-
K032114 (July 21, 2003) cleared as ACUSON® Sequoia 8.0 Diagnostic Ultrasound . System.
The Sequoia Diagnostic Ultrasound System has been designed to conform to the following product safety standards:
- UL 2601-1, Safety Requirements for Medical Equipment .
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
- AIUMNEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic t Ultrasound
- AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 93/42/EEC Medical Device Directive .
- Safety and EMC Requirements for Medical Equipment .
- EN 60601-1 .
- EN 60601-1-1 .
- EN 60601-1-2 .
- ISO 10993 Biocompatibility ●
- The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achievable)
Intended Use:
The Sequoia platform is intended for use in the following applications:
General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
2
Technological Comparison to Predicate Device:
The Sequoia is substantially equivalent in its technologies and functionality to the Sequoia 8.0 Diagnostic Ultrasound System that is already cleared under 510(k) premarket notification number K032114.
The Sequoia functions in the same manner as other diagnostic ultrasound systems, in that they transmit ultrasonic energy into the body via a transducer. In the body, acoustic impedance of different tissues reflect different amounts of ultrasound energy back to the mipedatios of arrerent rrocessing of received echoes is performed to generate twodimensional on-screen images of anatomic structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving blood as a spectrum, or as color-coded two-dimensional images. All predicate devices listed above, allow for specialized measurements of structures and flow, and provide various calculations' functions.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three wing-like extensions.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2004
Mr. Iskra Mraković Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc. Ultrasound Division 1230 Shorebird Way P.O. Box 7393 MOUNTAIN VIEW CA 94039-7393
Re: K041319
Trade Name: Sequoia 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: 90 IYN, IYO, and ITX Dated: May 17, 2004 Received: May 18, 2004
Dear Mr. Mraković:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your between mined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated on the 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 Cosments Act (ree). "Tou mayy accessors) sprovisions of the Act include requirements for annual provisions of inting 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 Sequoia Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 4C1 | EC10c5 | 8L5T |
|---|---|---|
| 5C2 | EV8C4 | 13L5SP |
| 6C2 | 6L3 | 15L8 |
| 8C4 | 8L5 | 15L8w |
4
Page 2 - Mr. Mraković
| V5M TEE | 4V1c | 8V5 |
|---|---|---|
| V7M TEE | 4V2 | 10V4 |
| V7B TEE | 5V2c | AUX CW |
| 3V2c | 7V3c | AcuNav (IC10V5 or 10F10) |
| 4V1 | 8V3 |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may be subject to such additional controller and any any any and 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 FICA has made a determination that your device complies with other requirements of the Act or any FDA has made a decemination administered by other Federal agencies. You must comply with all I coral statutes and regulations annumes timited to: registration and listing (21 CFR Part 807); the Act 31cquirements, morading, vanufacturing practice requirements as set forth in the quality labeling (21 CFR Part 001), good manatator, and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device rife I Dr Inding of substantal v 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 rr you dosire of Compliance at (301) 594-4591. Additionally, for questions on the promotion contact the Office of Compination as as contact the Office of Compliance at (301) 594-4639. Also, and advertising or your as nevel, "Misbranding by reference to premarket notification" (21 CFR prease note in regalation on the on your responsibilities under the Act may be obtained from 1 at 001:57). Other general Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy Shoydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
510(k) Number (if known):
Device Name:
Sequoia Diagnostic Ultrasound System
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | P | P | P | P | P | P | | P* | P |
| Adult Cephalic | | P | P | P | P | P | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | P | P | P | P | P | P | | P* | P |
| Transrectal | | P | P | P | P | P | P | | P* | P |
| Transvaginal | | P | P | P | P | P | P | | P* | P |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal
(Superficial) | | P | P | P | P | P | P | | P* | P |
| Other (specify) *** | | P | P | P | P | P | P | | P* | P |
Other (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+CWD+Color Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE **small organs (breast, testes, thyroid, penis) ***neonatal cardiac
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041319
6
510(k) Number (if known):
4C1 Device Name:
Intended Use:
.
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(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
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P | |
| Small Organ
(specify)** | | P | P | P | P | P | P | | P* | P | |
| Neonatai Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P | |
| Trans-csophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvagınal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skelctal
(Conventional) | | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, _______________________________________________________________________________________________ B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+CWD+Color Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
**small organs (breast, testes, thyroid, penis)
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) |
|---|
| --------------------------------------- |
Nancy C. Brogdon
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K041319 |
7
510(k) Number (if known):
5C2 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(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
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
Onler (specity)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+Clarify Dopler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sign-Off Division of Reproduc and Radiological Devic 510(k) Number
8
510(k) Number (if known):
6C2 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
(Juler (Speety)
P=previously cleared by the FDA under premarket notifications #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+Clarify Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
** small organs (breast, testes, thyroid, penis)
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Royston
(Division Sign Division of Reprod and Radiological Device 510(k) Number
9
510(k) Number (if known):
8C4 Device Namc:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | P* | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
Other (specity)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+I WD+Color Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Hodgson
(Division Sign Division of Reproduc and Radiological Devic 510(k) Number
10
510(k) Number (if known):
EC10c5 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | P | | P* | P |
| Transrectal | | P | P | P | P | P | P | | P* | P |
| Transvaginal | | P | P | P | P | P | P | | P* | P |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skelctal
(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
| *Combinations include: | B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, |
|---|---|
| B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, | |
| B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE |
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign Division of Reproduct and Radiological Devices 510(k) Number
11
510(k) Number (if known):
EV8C4 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | P* | P |
| Transvaginal | | P | P | P | P | P | P | | P* | P |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (concil.) | | | | | | | | | | |
Other (specify) P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+CWD+Color Doppler, B+CWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Croagdon
(Division Sign-Off Division of Reproductiv and Radiological Devic 510(k) Number
12
510(k) Number (if known):
6L3 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|---------------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal
Intraoperative | | P | P | P | P | P | P | | P* | P |
| Abdominal
Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | | | | | | | | P* | P |
| Small Organ
(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal
(Superficial) | | P | P | P | P | P | P | | P* | P |
| Other (specify) | | | | | | | | | | |
Oulci (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+Clarify D+Color Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
**small organs (breast, testes, thyroid, penis)
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Shosdon
ivision Sign Division of Reproduc Ana Radiological Device 1 (ik) Number _
13
510(k) Number (if known):
81.5 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|---------------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal
Intraoperative | | P | P | P | P | P | P | | P* | P |
| Abdominal
Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | | | | | | P | | P* | P |
| Small Organ
(specify)** | | P | P | P | P | P | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | P* | P |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal
(Superficial) | | P | P | P | P | P | P | | P* | P |
| Other (specify) | | | | | | | | | | |
Other (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+I WD+Color Doppler, B+C++B ver Doppler, B+CWD+Power Doppler, B+Clarify VE
**small organs (breast, testes, thyroid, penis)
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Maurice bordon
(Division Sign-Off) Division of Reproductive and Radiological Devices 510(k) Number
14
510(k) Number (if known):
8LST Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal
(Superficial) | | P | P | P | P | P | P | | P* | P |
| Other (specify) | | | | | | | | | | |
Other (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+I WDTColor Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
** small organs (breast, testes, thyroid, penis)
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Beadon
(Division Sign-Off)
Division of Reproductive, Abdom and Padiological Devices 5 !! #k) Number __
15
510(k) Number (if known):
13L5SP Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging | |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|---|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | P | P | | P | | P* | P | |
| Intraoperative
Abdominal | | P | P | P | P | P | | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | P | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | P | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | P* | P |
| Peripheral Vessel | | P | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | P* | P |
| Musculo-skeletal
(Conventional) | | P | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal
(Superficial) | | P | P | P | P | P | P | P | | P* | P |
| Other (specify) | | | | | | | | | | | |
Other (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
**small organs (breast, testes, thyroid, penis)
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sign-Off Division of Reproductive and Radiological Device 510(k) Number .
16
510(k) Number (if known):
1518 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging | |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|---|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | P* | | |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | | P* | P |
| Pediatric | | P | P | P | P | P | P | | | P* | P |
| Small Organ
(specify)** | | P | P | P | P | P | P | | | P* | P |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | P* | P |
| Cardiac | | P | P | P | P | P | P | | | P* | P |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | P* | P |
| Peripheral Vessel | | P | P | P | P | P | P | | | P* | P |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | P | P | P | P | P | P | | | P* | P |
| Musculo-skeletal
(Superficial) | | P | P | P | P | P | P | | | P* | P |
| Other (specify) | | | | | | | | | | | |
Outler (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppier, B+CWD+Color Doppler, B+Power Doppler, D+I WD+Color Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
** small organs (breast, testes, thyroid, penis)
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Thompson
(Division Sig Division of Reproductive and Radiological Devices 510(k) Number _
17
510(k) Number (if known):
15L8w Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | P* | P |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | P | P | P | P | P | P | | P* | P |
| Musculo-skeletal
(Superficial) | | P | P | P | P | P | P | | P* | P |
| Other (specify) | | | | | | | | | | |
Onler (spectly)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, -Comomations moraler, B+CWD+Color Doppler, B+Power Doppler, B+Clarify D+Color Doppler, B+C+PD+Dolor Doppler, B+CWD+Power Doppler, B+Clarify VE
** small organs (breast, testes, thyroid, penis)
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Hodgson
(Division Sign-Off Division of Reproductive and Radiological Device 510(k) Number
18
510(k) Number (if known):
Device Name:
V5M TEE
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | P | P | P | P | P | P | | P* | P |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
Other (specif)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Division of Reproductiv and Radiological Devices 510(k) Number
19
510(k) Number (if known):
V7M TEE Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-csophageal | | P | P | P | P | P | P | | P* | P |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
Other (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off Division of Reproductive, and Radiological Devices 510(k) Number _
20
510(k) Number (if known):
V7B TEE Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | P | P | P | P | P | P | | P* | P |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
Other (specity)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, Comomations Doppler, B+CWD+Color Doppler, B+Power Doppler, D+I WD+Color Doppler, B+C+FB Foor Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Thompson
(Division Sigr Division of Reproduct and Radiological Device 510(k) Number
21
510(k) Number (if known):
Device Name:
3V2c
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | P | | P | P | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | | |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | P* | P |
| Adult Cephalic | | P | P | P | P | P | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | P | P | P | P | P | P | | P* | P |
Other (specify)***
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196. Other (specify)
Additional Comments:
*Combinations include:
| B+M |
|---|
| B+PWD |
| B+CWD |
| B+Color Doppler |
| B+M+ Color Doppler |
| B+PWD+Color Doppler |
| B+CWD+Color Doppler |
| B+Power Doppler |
| B+M+Power Doppler |
| B+PWD+Power Doppler |
| B+CWD+Power Doppler |
| B+Clarify VE |
** * neonatal cardiac
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CODE (ODE) Comment of CORPL Office Evaluation (ODE) VRITE BELOW THIS EINE-CONTITUE - ---------------------------------------------------------------------------------------------------------------------------------------------
Nancy C hoydon
(Division Sign-Off) Division of Reproductive, Abdomina on Rediological Devices ; > as) Number _______________________________________________________________________________________________________________________________________________________________
22
510(k) Number (if known):
4V1 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (snecify) | | | | | | | | | | |
Other (specity)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+C WD+Color Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-O Division of Reproductiv and Radiological Devices 510(k) Number
23
510(k) Number (if known):
4V1c Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(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
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | P* | P |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify) *** | | P | P | P | P | P | P | | P* | P |
Omet (Specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+Clarify Doppler, B+C+P+Color Dopper, B+CWD+Power Doppler, B+Clarify VE
***neonatal cardiac
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Hogdon
(Division Sign-Off Division of Reproductive and Radiological Device 510(k) Number
24
510(k) Number (if known):
4V2 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging | |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|--|
| Ophthalmic | | | | | | | | | P* | | |
| Fetal | | P | P | P | P | P | P | | | P | |
| Abdominal | | P | P | P | P | P | P | | P* | P | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P | |
| Small Organ
(specify)** | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
Onler (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+Clarify Dopler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broydon
(Division Sign-Off Division of Reproductive and Radiological Devices 510(k) Number _
25
510(k) Number (if known):
5V2c Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify) ** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeleta!
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify)*** | | P | P | P | P | P | P | | P* | P |
Other (specis)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, Comomations menader, B+CWD+Color Doppler, B+Power Doppler, B+Clarify Doppler, B+C WD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
***neonatal cardiac
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Bragdon
(Division Sign-Off)
Division of Reproductive, Abdomin and Radiological Device 510(k) Number J
26
510(k) Number (if known):
7V3c Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | P* | P |
| Adult Cephalic | | | | | | | | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify)*** | | P | P | P | P | P | P | | P* | P |
Outer (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+I WD+Color Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
***neonatal cardiac
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Chrogdon
(Division Sign-O Division of Reproductive and Radiological Devices 510(k) Number .
27
510(k) Number (if known):
8V3 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(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
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | P* | P |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify)*** | | P | P | P | P | P | P | | P* | P |
Other (specity)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
***neonatal cardiac
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Naveen Gordon
(Division Sign Division of Reproductiv Ahdom and Radiological Devices 510(k) Number
28
510(k) Number (if known):
8V5 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(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
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | P* | P |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify)*** | | P | P | P | P | P | P | | P* | P |
Other (specify)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, D+I WD+Color Doppler, B+C+FB+Corr Doppler, B+CWD+Power Doppler, B+Clarify VE
***neonatal cardiac
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Roepke
(Division Sign. Abdomi! Division of Reproductive, and Radiological Devices : (x) Nember
29
510(k) Number (if known):
10V4 Device Name:
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | P* | P |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Neurological | | P | P | P | P | P | P | | P* | P |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify)** | | P | P | P | P | P | P | | P* | P |
| Neonatal Cephalic | | P | P | P | P | P | P | | P* | P |
| Adult Cephalic | | P | P | P | P | P | P | | P* | P |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (specify)*** | | P | P | P | P | P | P | | P* | P |
Other (specity)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, Comomations monoler, B+CWD+Color Doppler, B+Power Doppler, D+Clarify D+Color Doppler, B+CWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE **small organs (breast, testes, thyroid, penis) ***neonatal cardiac
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
1(k) Number K041319
30
510(k) Number (if known):
Device Name:
AUX CW
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | P | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skcletal
(Conventional) | | | | | | | | | | |
| Musculo-skelctal
(Superficial) | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
P=previously cleared by the FDA under premarket notification # K032114.
Additional Comments:
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broadbent
(Division Sign-Off Division of Reproductive and Radiological Devices 510(k) Number
31
510(k) Number (if known):
Device Name:
Transducer:
Sequoia Diagnostic Ultrasound System, Harmonic Imaging
AcuNav (IC10V5 or 10F10) Diagnostic Ultrasound Catheter
Indications for Use:
The AcuNav™ Diagnostic Ultrasound Catheter is intended fur intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Harmonic
Imaging |
|------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-luminal | | P | P | P | P | P | P | | P* | P |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (Intra-Cardiac) | | P | P | P | P | P | P | | P* | P |
Onler (intra-Cardiae)
P=previously cleared by the FDA under premarket notifications #K033650 and #K033196.
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Snowdon
(Division Sign(Off)
Division of Reproductive, Abdominal,
and Radiological Devices
(k) Number R041319
Diagnostic Ultrasound Indications for Use Form