(14 days)
Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The CV70 system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already proprietary boxware, under the following 510(k) Premarket Notification number: K032111 (July 18, 2003) cleared as ACUSON CV70™ Cardiovascular System. The CV70 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 transducer, where post processing of received echoes is performed to generate two-dimensional images of 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. The predicate device provides specialized measurements of structures and flow, and provide various calculations functions.
This document is a 510(k) submission for the ACUSON CV70™ Cardiovascular System, an ultrasound device. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K032111) and detailing its intended uses and compliance with safety standards.
Based on the provided text, there is NO information about acceptance criteria, study design, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case (MRMC) comparative effectiveness studies regarding the device's performance.
The document is not a study report demonstrating the device meets performance criteria in the way described in your request (i.e., evaluation of AI/algorithm performance against a defined ground truth). Instead, it's a regulatory submission affirming that the updated model of an existing device is substantially equivalent to its predicate.
However, I can extract the intended uses of the device and its various transducers as a proxy for what the device is designed to do, which effectively serves as the "acceptance criteria" for its functionality as an ultrasound system in a regulatory context when demonstrating substantial equivalence.
Summary of Acceptance Criteria and Reported Device Performance (as demonstrated by intended uses and substantial equivalence):
The "acceptance criteria" in this context are the previously cleared intended uses and performance of the predicate device (ACUSON CV70™ Cardiovascular System, K032111). The reported device performance is that the new ACUSON CV70™ Cardiovascular System is substantially equivalent and performs in the same manner as the predicate, transmitting and processing ultrasonic energy to display real-time images and perform measurements.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission for a diagnostic ultrasound system, the "acceptance criteria" are defined by the cleared Intended Uses and modes of operation for each transducer, which are considered substantially equivalent to the predicate device. The "reported device performance" is implicitly that the device successfully performs these functions as intended and is as safe and effective as the predicate.
Below is a combined table summarizing the overarching intended uses and modes of operation for the ACUSON CV70™ Cardiovascular System across its various transducers. "P" indicates previously cleared indications, and "E" indicates new indications added under Appendix E for a specific transducer. "N" indicates new indications for a specific transducer. "BMDC" stands for B-mode, M-mode, Doppler (PWD-Pulsed Wave, CWD-Continuous Wave), and Color Doppler.
| Clinical Application | Mode of Operation (P/N/E) | Other Features (P/N/E) |
|---|---|---|
| Fetal | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, B&W SieScape, Power SieScape |
| Abdominal | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, B&W SieScape, Power SieScape |
| Intraoperative (Abdominal, Neurological) | B, M, PWD, Color, Amplitude Doppler | 3D Imaging |
| Pediatric | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, B&W SieScape, Power SieScape |
| Small Organ | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, B&W SieScape, Power SieScape |
| Neonatal Cephalic | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, B&W SieScape, Power SieScape |
| Adult Cephalic | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging |
| Cardiac | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, Contrast Agent Imaging, B&W SieScape, Power SieScape |
| Transesophageal | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging |
| Peripheral Vessel | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, B&W SieScape, Power SieScape |
| Laparoscopic | B, M, PWD, Color, Amplitude Doppler | 3D Imaging, B&W SieScape, Power SieScape |
| Musculo-skeletal (Conventional & Superficial) | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, B&W SieScape, Power SieScape |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This document does not describe a clinical study with a "test set" in the context of an algorithm or AI performance evaluation. The submission demonstrates substantial equivalence to a predicate device, relying on technical comparison, safety standards compliance, and previous clearances.
- Data Provenance: Not applicable. There is no mention of specific clinical data or patient data used for performance testing in this 510(k) summary. The comparison is primarily against the established performance of the legally marketed predicate device (K032111) and compliance with recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. No specific "ground truth" establishment by experts for a test set is described in this regulatory submission.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. No test set requiring expert adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This document does not present any MRMC comparative effectiveness studies. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance Study: No. This document does not describe a standalone algorithm performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable. The submission for substantial equivalence relies on the established performance and safety profile of the predicate device, not on a new ground truth established for a specific clinical outcome or diagnostic accuracy study.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This document does not describe the development or training of an AI algorithm; therefore, there is no training set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable.
{0}------------------------------------------------
Siemens Medical Solutions USA, Inc. Ultrasound Division
ACUSON CV70™ Cardiovascular System Special 510(k) Submission
AUG 1 3 2004
SECTION 11
510(k) Summary of Safety and Effectiveness
| Sponsor: | Siemens Medical Solutions USA, Inc., Ultrasound Division1230 Shorebird WayP.O. Box 7393Mountain View, California 94039-7393 |
|---|---|
| Contact Person: | Patrick LynchRegulatory AffairsTelephone: 425-557-1825Fax: 425-391-9198 |
| Submission Date: | July 28, 2004 |
| Device Name: | ACUSON CV70™ Cardiovascular 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 |
Predicate Devices:
-
K032111 (July 18, 2003) cleared as ACUSON CV70™ Cardiovascular System. .
Device Description:
The CV70 system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already proprietary boxware, under the following 510(k) Premarket Notification number:
-
# K032111 (July 18, 2003) cleared as ACUSON CV70™ Cardiovascular System. .
{1}------------------------------------------------
The CV70 Cardiovascular System has been designed to conform to the following product safety standards:
- UL 60601-1, 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 . 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 CV70 platform is intended for use in the following applications:
Abdominal, Intraoperative, Small Parts, Transcranial, Cardiac, Transesophageal, Pelvic, Abounmal, Intractiper and Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular 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.
Technological Comparison to Predicate Device:
The CV70 is substantially equivalent in its technologies and functionality to the CV70 The Cardiovascular System that is already cleared under 510(k) premarket notification number K032111.
The CV70 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 transducer, where post processing of received echoes is performed to generate twotransdates, where poss proving structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving Doppler principles are as color-coded two-dimensional images. The predicate device blood as a spectrain, or specialized measurements of structures and flow, and provide various calculations' functions.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird-like symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The bird-like symbol consists of three curved lines that resemble wings or feathers, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 2004
Mr. Patrick Lynch Regulatory Affairs Siemens Medical Solutions USA, Inc. 1230 Shorebird Way P.O. Box 7393 MOUNTAIN VIEW CA 94039-7393
Re: K042044
K042044
Trade Name: ACUSON CV70™ Cardiovascular 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 transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: July 28, 2004 Received: July 30, 2004
Dear Mr. Lynch:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Dection of 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 micrslate commerce priver to may 20, been reclassified in accordance with the provisions of the Amendinents, of to devices that have t (Act). You may, therefore, market the device, subject to reactal i ood, Drog, and Coomers of the Act. The general controls provisions of the Act include the general controls provisions of and issing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for IThis delcrimitation of substantial vquiliovascular System, as described in your premarket notification:
Transducer Model Number
| C5-2 Convex Array | 5.0C50+ Convex Array |
|---|---|
| C6-2 Convex Array | 5.0L45 Linear Array |
| C8-5 Convex Array | 7.5L70 Linear Array |
{3}------------------------------------------------
P4-2 Phased Sector Array LB5-2 Linear Array 5.0P10 Phased Sector Array L10-5 Linear Array V5Ms Phased Sector Array TEE VF13-5 Linear Array CW2 Continuous Wave Doppler VF13-5SP Linear Array CW5 Continuous Wave Doppler 7.5L50I Linear Array P9-4 Phased Sector Array 7.5L50Q Linear Array LAP8-4 Laparoscopic
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classificul (sec above) into entires major regulations affecting your device
it may be subject to such additional controls. Existing major regulations and it may be subject to Such additional controls: "Interiographia" and to 898. In addition, FDA can be found in the Code of I caera. Rogerming your device in the Federal Register. may publish luttler announcements concernming your acquivalence determination does not mean Please be advised that I DA s issualto of a builde complies with other requirements of the Act that FDA has made a determination administered by other Federal agencies. You must or any Federal statures and regulations adminities. but not limited to: registration and listing (21 comply with an the Act 3 requirements, new 801); good manufacturing practice requirements as set CFR Part 607), labeling (21 CFRT art 807), good manat 820); and if applicable, the electronic forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping I his detenmination of Substance 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 In Appendix U, (chelosod) of the Senter vice of Chrisound Systems and Transducers." If the special Seeking Marketing Clearantee of Diagnoule values (e.g., acoustic output greater than approved report is incomplete or comains anasvepat apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the ma.iufacturer's 510(k) number. It should be clearly and The special report should forces.NLE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket I mis letter will anow you to organ mannulis .
The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Dri manig of vastion 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 80), please If you desire specific at not your your 301) 594-4591. Additionally, for questions on the Comact the Office of Compilance at (2007), please contact the Office of Compliance at (301) 594
{4}------------------------------------------------
Page 3 - Mr. Lynch
- Also, please note the regulation entitled, "Misbranding by reference openariket 46.39. Also, please note the regulation on the responsibilities under tesponsibilities under the notification" (21 CFR Part 807.97). Onel general manufacturers, International and Consumer
Act may be obtained from the Division of Small Manufacturers, International and Con Act may be obtained from the DVASion of Sman Manalastian 2011) 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 C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
{5}------------------------------------------------
510(k) Number (if known)
ACUSON CV70 Cardiovascular System
Device Name:
ACUSON CV70 cardiovascular system
Diagnostic imaging or fluid flow analysis of the human body as the
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Operation | |||||||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |||
| Ophthalmic | |||||||||||||
| Fetal | P | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||||
| Abdominal | P | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||||
| Intraoperative(Note 6) | P | P | P | P | P | P | BMDC | Note 3 | |||||
| IntraoperativeNeurological | P | P | P | P | P | P | BMDC | Note 3 | |||||
| Pediatric | P | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||||
| Small Organ(Note 1) | P | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||||
| Neonatal Cephalic | P | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||||
| Adult Cephalic | P | P | P | P | P | P | P | BMDC | Note 2,3 | ||||
| Cardiac | P | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7 | ||||
| Transesophageal | P | P | P | P | P | P | P | BMDC | Note 2,3 | ||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Transurethral | |||||||||||||
| Intravascular | |||||||||||||
| Peripheral vessel | P | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||||
| Laparoscopic | P | P | P | P | P | P | BMDC | Note 3 | |||||
| Musculo-skeletalConventional | P | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||||
| Musculo-skeletal | P | P | P | P | P | P | P | BMDC | Note 2,3,4,5 |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
P
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
P
Ensemble tissue harmonic imaging Note 2
3D imaging Note 3
Superficial Other (specify)
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
THE CONTINUE OFFICE CELL OFFICE (CONTINUE ON ANCE (ODE) Concurrence of CDRH, Office of Device Evaluation (ODE)
P
Prescription Use (Per 21 CFR 801.109)
C
Nancy C. Broglon
(Division Sign-Off)
Division of Reproductive, Abdominal,
BMDC
and Radiological Devices 510(k) Number
{6}------------------------------------------------
510(k) Number (if known):
Device Name
C5-2 Convex Array Transducer for use with: ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:
Intended Use:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Ensemble tissue harmonic imaging Note 2
3D imaging Note 3
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
(Please 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 Thoydon
(Division Sign Off)
(Division Sign-O Division of Reproductive. Abdom and Radiological Devices 510(k) Number
{7}------------------------------------------------
510(k) Number (if known):
Device Name
Intended Use:
C6-2 Convex Array Transducer for use with: ACUSON CV70 Cardiovascular System Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Ensemble tissue harmonic imaging Note 2
3D imaging Note 3
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
(PLEASE 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. Broadon
(Division Sign-Off, Division of Reproducti and Radiological Devices 510(k) Number
{8}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
C8-5 Convex Array Transducer for use with: ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Small Organ(Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Neonatal CephalicAdult Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Cardiac | E | E | E | E | E | BMDC | Note 2,3,4,5 | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Musculo-skeletalSuperficial | E | E | E | E | E | BMDC | Note 2,3,4,5 | |||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
3D imaging Note 3
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
(PLEASE 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,
Division of Reproductive, and Radiological Devices 510(k) Number_
{9}------------------------------------------------
510(k) Number (if known):
Device Name
Intended Use:
5.0C50+ Convex Array Transducer for use with: ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Small Organ(Note 1) | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | E | E | E | E | E | E | BMDC | Note 2,3,4,5 | ||
| Musculo-skeleta!Superficial | E | E | E | E | E | E | BMDC | Note 2,3,4,5 | ||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note :2 Ensemble tissue harmonic imaging
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
(PLEASE 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 K042044
510(k) Number
{10}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
5.0L45 Linear Array Transducer for use with ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Note 1) | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
3D imaging Note 3
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{11}------------------------------------------------
510(k) Number (if known):
Device Name
7.5L70 Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Small Organ(Note 1) | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | E | E | E | E | E | BMDC | Note 3,4,5 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- 3D imaging Note 3
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
(PLEASE 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
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number KD42044
{12}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
LB5-2 Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | ||
| Ophthalmic | ||||||||||||
| Fetal | P | P | P | P | P | BMDC | Note 4,5 | |||||
| Abdominal | P | P | P | P | P | BMDC | Note 4,5 | |||||
| IntraoperativeAbdominal | ||||||||||||
| IntraoperativeNeurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral vessel | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletalConventional | ||||||||||||
| Musculo-skeletalSuperficial | ||||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
(PLEASE 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 K042044
{13}------------------------------------------------
510(k) Number (if known):
Device Name
Intended Use:
L10-5 Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Small Organ(Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
(PLEASE 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)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K042044 |
|---|---|
| --------------- | --------- |
{14}------------------------------------------------
510(k) Number (if known):
Device Name
Intended Use:
VF13-5 Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 3,4,5 | ||
| Small Organ(Note 1) | P | P | P | P | P | P | BMDC | Note 3,4,5 | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessei | P | P | P | P | P | P | BMDC | Note 3,4,5 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | P | BMDC | Note 3,4,5 | ||
| Musculo-skeletalSuperficial | P | P | P | P | P | P | BMDC | Note 3,4,5 | ||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- 3D imaging Note 3
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Toure Broadn
(Division Sign Off)
Division of Reproductive, A and Radiological Devices 510(k) Number
{15}------------------------------------------------
510(k) Number (if known):
Device Name
VF13-5SP Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(note 6) | P | P | P | P | P | BMDC | Note 3 | |||
| IntraoperativeNeurological | P | P | P | P | P | BMDC | Note 3 | |||
| Pediatric | P | P | P | P | P | BMDC | Note 3 | |||
| Small Organ(Note 1) | P | P | P | P | P | BMDC | Note 3 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 3 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMDC | Note 3 | |||
| Musculo-skeletalSuperficial | P | P | P | P | P | BMDC | Note 3 | |||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Note 3 3D imaging
Note 6 For example: abdominal, vascular
(PLEASE 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, Abdominal,
and Radiological Devices
510(k) Number K042044
{16}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
7.5L50I Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Intraoperative(Note 6) | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Note 1) | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number [K042044](https://510k.innolitics.com/search/K042044)
{17}------------------------------------------------
510(k) Number (if known):
Device Name
7.5L50Q Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Intraoperative<br>(Note 6) | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
> (Please 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)
(Division Sign-Off)
Division of Reproductive. Abdominal,
and, Devices [K042044](https://510k.innolitics.com/search/K042044)
510(k) Number
{18}------------------------------------------------
510(k) Number (if known):
Device Name
LAP8-4 Laparoscopic Transducer for use with: ACUSON CV70 Cardiovascular System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>(Note 6) | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | P | P | P | | P | P | | BMDC | Note 3,4,5 | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Marcy C. Krogdor
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number [K042044](https://510k.innolitics.com/search/K042044)
{19}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
P4-2 Phased Sector Array Transducer for use with: ACUSON CV70 Cardiovascular System Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,7 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
Note 7 Contrast agent imaging
> (PLEASE 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. Snogdon
---
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 510(k) Number
{20}------------------------------------------------
510(k) Number (if known):
Device Name
5.0P10 Phased Sector Array Transducer for use with: ACUSON CV70 Cardiovascular System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2 |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,7 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Ensemble tissue harmonic imaging Note 2
Note 7 Contrast agent imaging
> (PLEASE 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 Broadon
(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{21}------------------------------------------------
510(k) Number (if known):
Device Name
Intended Use:
V5Ms Phased Sector Array TEE Transducer for use with: ACUSON CV70 Cardiovascular System Ultrasound imaging or fluid flow analysis of the human body as follows:
--
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number _
{22}------------------------------------------------
510(k) Number (if known)
Device Name:
Intended Use:
CW2 Continuous Wave Doppler Transducer for use with: ACUSON CV70 Cardiovascular System Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | P | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
(PLEASE 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)
Darcy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 519(k) Number
{23}------------------------------------------------
510(k) Number (if known):
Device Name
CW5 Continuous Wave Doppler Transducer for use with: ACUSON CV70 Cardiovascular System Ultrasound imaging or fluid flow analysis of the human body as follows:
Intended Use:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sian-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number
{24}------------------------------------------------
510(k) Number (if known):
Device Name
-
P9-4 Phased Sector Array Transducer for use with: ACUSON CV70 Cardiovascular System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | N | N | N | | BMDC | Note 2 |
| Abdominal | | N | N | N | N | N | N | | BMDC | Note 2 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | N | N | N | N | N | N | | BMDC | Note 2 |
| Pediatric | | N | N | N | N | N | N | | BMDC | Note 2 |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | N | N | N | N | N | N | | BMDC | Note 2 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | N | N | N | | BMDC | Note 2,7 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | N | N | N | N | N | N | | BMDC | Note 2 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Ensemble tissue harmonic imaging Note 2
Note 7 Contrast agent imaging
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number [K042044](https://510k.innolitics.com/search/K042044)
§ 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.