(13 days)
No
The document does not mention AI, ML, deep learning, or any related terms in the device description or other sections. The description focuses on standard ultrasound imaging modes and post-processing.
No
The device description indicates it is a "diagnostic ultrasound system," and its intended use is for "clinical diagnosis purposes," not for treatment.
Yes
The "Device Description" explicitly states, "The CV70 is a general purpose, mobile, software-controlled, diagnostic ultrasound system." Additionally, the "Intended Use" section mentions that the system provides for "analysis of information that is used for clinical diagnosis purposes."
No
The device description explicitly states it is a "diagnostic ultrasound system" and mentions transmitting ultrasonic energy and receiving echoes, which are hardware functions. While it is software-controlled, it is not solely software.
Based on the provided information, the CV70 ultrasound imaging system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- CV70 Function: The description clearly states that the CV70 is a diagnostic ultrasound system that transmits ultrasonic energy into patients and processes the received echoes to generate images of structures within the body. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
- Intended Use: The intended uses listed (Abdominal, Fetal, Cardiac, etc.) are all applications of imaging the internal structures of a living patient.
Therefore, the CV70 is a diagnostic imaging device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CV70 ultrasound imaging system is intended for the following applications: Abdominal, Obstetrical, Gynecological, Cardiac, Intracardiac, Transesophageal, Intraoperative, Small Parts, Periprocedural, Cerebrovascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications.
The system also provides for the measurement of anatomical structures and for analysis of information that is used for clinical diagnosis purposes.
Product codes
90 IYN, IYO, ITX and 74 DQO
Device Description
The CV70 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect and an on-screen display for thermal and mechanical. The system transmits and receives primary or secondary harmonic ultrasound echo data and displays it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, D Mode, a combination of modes, or Harmonic Imaging, or 3D imaging, on a CRT display.
The CV70 has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment
- EN/IEC 60601-1
- EN/IEC 60601-1-1
- EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power
- ISO 10993-1 Biocompatibility
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Obstetrical, Gynecological, Cardiac, Intracardiac, Transesophageal, Intraoperative, Small Parts, Periprocedural, Cerebrovascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, Peripheral Vascular, Fetal, Intraoperative Neurological, Pediatric, Neonatal Cephalic, Adult Cephalic, Transrectal, Transvaginal, Transurethral, Intravascular, Laparoscopic, Breast, Testes, Thyroid, Penis, Prostate
Indicated Patient Age Range
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three flowing lines representing the body and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 9 2005
Siemens Medical Solutions USA, Inc. Ultrasound Group % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K050240
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 ultrasound transducer Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: 90 IYN, IYO, ITX and 74 DQO Dated: September 30,2004 Received: February 2,2005
Dear Mr. Job:
This letter corrects our substantially equivalent letter of February 15, 2005 regarding the missing Regulation Number, Name, and Product Code.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the ACUSON CV70 Cardiovascular System, as described in your premarket notification:
1
Transducer Model Number
| C5-2 Convex Array | 7.5L50I Linear Array |
|---|---|
| C6-2 Convex Array | 7.5L50Q Linear Array |
| C8-5 Convex Array | LAP8-4 Laparoscopic |
| 5.0C50+ Convex Array | P4-2 Phased Sector Array |
| 5.0L45 Linear Array | 5.0P10 Phased Sector Array |
| 7.5L70 Linear Array | V5Ms Phased Sector Array TEE |
| LB5-2 Linear Array | CW2 Continuous Wave Doppler |
| L10-5 Linear Array | CW5 Continuous Wave Doppler |
| VF13-5 Linear Array | P9-4 Phased Sector Array |
| VF13-5SP Linear Array | AcuNav 8F Ultrasound Catheter |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information. including acoustic output measurements based on production line devices. requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
2
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours.
David A. Lyonn
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
KOSO240
510(K) SUMMARY
ACUSON CV70™ Cardiovascular system
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance This Summaly of Salely and encolvened is provisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
Submitted By: 1.
Siemens Medical Solutions USA, Inc., Ultrasound Division 22010 S.E. 51st Street Issaquah, WA 98029
FEB 1 5 2005
Contact Person:
Patrick Lynch Regulatory Affairs
Phone: (425) 557-1825 FAX: (425) 391-9198
Date Prepared:
September 3, 2004
Proprietary Name: 2.
ACUSON CV70™ Cardiovascular System
Common/ Usual Name:
Diagnostic Ultrasound System with Accessories
Classification Name:
| 21 CFR 892.1550 | ||
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | FR # 892.1550 | Product Code 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | FR # 892.1560 | Product Code 90-IYO |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX |
| Diagnostic Intravascular Catheter | FR # 870.1200 | Product Code 90-DQC |
Predicate Device: 3.
K042770, 10/20/2004, cleared as ACUSON CV70™ Cardiovascular System. K042770, 10/20/2004, cleared as ACUSON Sequoia™ Diagnostic Ultrasound System.
Device Description: 4.
Device Description.
The CV70 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect an on-sereen display for themal and re primary or secondary harmonic ultrasound echo data and modiantinin B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, ulsplay it in. D Mode, it would (f Mode, a combination of modes, or Harmonic Imaging, or 3D imaging, on a CRT display.
The CV70 has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment 트
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards ■
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment ■
- AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical 트 Acoustic Output Indices on Diagnostic Ultrasound Equipment
4
- AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound 트
- 93/42/EEC Medical Devices Directive I
- Safety and EMC Requirements for Medical Equipment I
- 트 EN/IEC 60601-1
- EN/IEC 60601-1-1 L
- I EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power I
- ISO 10993-1 Biocompatibility I
Intended Uses: 5.
intended USes.
The CV70 ultrasound imaging system is intended for the following applications: Abdominal, I The OVTO ultrasound Integrity of countial, OB/GYN, Cardiac, Intracardiac, Transesophageal, intraoperative, Omall Parts, Pranooranaa, CEravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications.
The system also provides for the measurement of anatomical structures and for analysis The System also provide information that is used for clinical diagnosis purposes.
Technological Comparison to Predicate Device: 6.
Technological oompany equivalent to the ACUSON CV70, cleared via K042770; and some The OW For Subolantian) Squoia, cleared via K042593. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of into patients, then portom post prositivin the body. All systems allow for specialized measurements of structures and flow, and calculations.
End of 510(k) Summary
5
510(k) Number (if known):
ACUSON CV70 Cardiovascular System
Device Name: Intended Use:
AOOOON of maging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | Combined
(Specify) | Other
(Specify) |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | | |
| 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 |
| Intraoperative
(Note 6) | | P | P | P | | P | P | BMDC | Note 3 |
| Intraoperative
Neurological | | P | P | P | | P | P | BMDC | Note 3 |
| 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 | | P | P | P | P | P | P | BMDC | Note 2,3,4,5 |
| Adult Cephalic | | P | P | P | P | P | P | BMDC | Note 2,3 |
| Cardiac | | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7 |
| Transesophageal | | P | P | P | P | P | P | BMDC | Note 2,3 |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Intravascular | | N | N | N | N | N | N | BMDC | Note 2,3,7,8 |
| Peripheral vessel | | P | P | P | P | P | P | BMDC | Note 2,3,4,5 |
| Laparoscopic | | P | P | P | | P | P | BMDC | Note 3 |
| Musculo-skeletal
Conventional | | P | P | P | P | P | P | BMDC | Note 2,3,4,5 |
| Musculo-skeletal
Superficial | | P | P | P | P | P | P | BMDC | Note 2,3,4,5 |
| Superficial | | N | N | N | N | N | N | BMDC | Note 8 |
(Specify)
N = new indication; P = previously cleared by FDA (K032111); 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
SD imaging
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Contrast agent imaging Note 7
Intracardiac imaging Note 8
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(PLEASE DO NOT WRITE BELOW CERS of Review Evelustion (ODE) | WRITE BEEOW THIS Office of Device Evaluation (ODE)
Prescription Use (Per 21 C
510(k) Number
Use (Per 21 CFR 801.109)
Nancyc Brindon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices, V.DE0214
Indications for Use Forms
Page 1 of 20
6
510(k) Number (if known):
Device Name:
Intended Use:
C5-2 Convex Array Transducer for use with: ACUSON CV70 Cardiovascular System ACUSUN CV70 Cardiovascular Oyoton.
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | 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 | ||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| 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 | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5 | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (Specify) |
Other (Specily)
N = new indication; P = previously cleared by FDA (K032111); E = added under Appendix E
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)
THE CONTINUE OF CONSTIC CORPH Off as of Davise Firelyetion (ODE) | WRITE BEEOW THIS EIRE SORH - Office of Device Evaluation (ODE)
Nancy Broydon
(Division Sign-Of Division of Reproductive and Radiological Devic 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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | 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 | |||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| 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-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA (K032111); E = added under Appendix E
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)
Nancy C bradon
(Division Sig Division of Reproductive, Abdon and Radiological Device 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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| 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 | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Adult Cephalic | ||||||||||
| Cardiac | E | E | E | E | E | BMDC | Note 2,3,4,5 | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Musculo-skeletal | ||||||||||
| Superficial | E | E | E | E | E | BMDC | Note 2,3,4,5 | |||
| Other (specify) |
N = new indication; P = previously cleared by FDA (K032111); E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
3D imaging Note 3
B&W SieScape panoramic imaging Note 4
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. Bridon
(Division Si Division of Reproductive, Abdo and Radiological Device 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 ACUSON CVTV Gardiovaooular Systems of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | 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 | ||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| 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-skeletal | ||||||||||
| Conventional | E | E | E | E | E | E | BMDC | Note 2,3,4,5 | ||
| Musculo-skeletal | ||||||||||
| Superficial | E | E | E | E | E | E | BMDC | Note 2,3,4,5 |
N = new indication; P = previously cleared by FDA (K032111); 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
Other (specify)
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 Croydon
(Division Sic Division of Renroduc ive. Al and Radiological Devic 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 ACUSON OVT o Garaitvaoualar Olysis of the human body as follows:
Mode of Operation Color Other Amplitude Combined Clinical Application Color Velocity M PWD CWD B (Specify) A (Specify) Doppler Doppler Imaging Ophthalmic Fetal Note 2,3,4,5 BMDC P P P P P P Abdominal Intraoperative Abdominal Intraoperative Neurological Pediatric Note 2,3,4,5 BMDC Small Organ P P P P ్రా P (Note 1) Neonatal Cephalic Adult Cephalic Cardiac Transesophageal Transrectal Transvaginal Transurethral Intravascular Note 2,3,4,5 BMDC P P P P P P Peripheral vessel Laparoscopic Note 2,3,4,5 Musculo-skeletal BMDC P P P P P P Conventional Musculo-skeletal Superficial Other (specify)
- and (Specification; P = previously cleared by FDA (K032111); 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)
Y Daniel C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050240
11
510(k) Number (if known):
Device Name:
7.5L70 Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System
Intended Use:
AOUOON CVT o Our of our analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| 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-skeletal | |||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 3,4,5 | ||||
| Musculo-skeletal | |||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 3,4,5 | ||||
| Other (specify) |
Other (Spoolly)
N = new indication; P = previously cleared by FDA (K032111); E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
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)
AND INCT WRITE.BELOW THIS LINE-CONTINE Evelustion (ODE) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy burden
(Division Sign Division of Reproduct and Radiological Device 510(k) Number
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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | 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 | |||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA (K032111); E = added under Appendix E
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)
Nancy C. Brogdon
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices : 1 %) Number _
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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| 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-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Musculo-skeletal | ||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 2,3,4,5 | |||
| Other (specify) |
N = new indication; P = previously cleared by FDA (K032111); 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)
Nancy Croydon
(Division Sign-Off)
Division of Reproductive, Abdominal,
Radiological Devices
Number K050240
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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| 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 vessel | P | P | P | P | P | P | BMDC | Note 3,4,5 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | P | BMDC | Note 3,4,5 | ||
| Musculo-skeletal | ||||||||||
| Superficial | P | P | P | P | P | P | BMDC | Note 3,4,5 | ||
| Other (specify) |
N = new indication; P = previously cleared by FDA (K032111); 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
(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, Abdi A Radiological Devices 5 = ((k) Number __
15
510(k) Number (if known):
Device Name:
VF13-5SP Linear Array Transducer for use with: ACUSON CV70 Cardiovascular System ACUSON CVT 0 Gardrovasoalar Gyoton.
Diagnostic imaging or fluid flow analysis of the human body as follows:
Intended Use:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| (note 6) | P | P | P | P | P | BMDC | Note 3 | ||||
| Intraoperative | |||||||||||
| Neurological | 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-skeletal | |||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 3 | ||||
| Musculo-skeletal | |||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 3 | ||||
| Other (specify) |
(Citier (Open); )
N = new indication; P = previously cleared by FDA (K032111); E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 3 3D imaging
For example: abdominal, vascular Note 6
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CONTINUE (CONTINUE OFFICE OFFICE (Projection (ODE) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sigh-O Division of Reproductive. Abdor and Radiological Devices 510(k) Number _
16
510(k) Number (if known):
Device Name:
7.5L501 Linear Array Transducer for use with:
Intended Use:
ACUSON CV70 Cardiovascular System ACUSON CVT 0 Cardiovasouna: Gyoten.
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | 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 | |||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| 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-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA (K032111); 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)
Nancy L. Brogdon
(Division Division of Reproductive, Abdo and Radiological Devices 510(k) Number
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | 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 | ||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| 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-skeletal | |||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 3,4,5 | ||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA (K032111); 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)
Nancyc Brogdon
(Division S Division of Reproductive. Abd and Radiological Devices :- 1 (Kk) 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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| (Note 6) | P | P | P | P | P | BMDC | Note 3,4,5 | |||
| Intraoperative | ||||||||||
| 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 | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA (K032111); E = added under Appendix E
3D imaqinq Note 3
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)
Nancy Chosdon
(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 5 (Xk) Number ________________________________________________________________________________________________________________________________________________________________
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3 | ||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| 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 | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA (K032111); E = added under Appendix E
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
Contrast agent imaging Note 7
(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)
Nancyc Hogdon
(Division Sign-Off)
Division of Reproductive. Abdomir on Padiological Devices - - Vie Nember - ..
20
510(k) Number (if known):
Device Name:
5.0P10 Phased Sector Array Transducer for use with: ACUSON CV70 Cardiovascular System 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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | Note 2 | ||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2 | ||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| 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 | P | BMDC | Note 2,7 | |||||||
| Cardiac | P | P | P | P | P | P | BMDC | Note 2,7 | ||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial |
(Specify)
N = new indication; P = previously cleared by FDA (K032111); E = added under Appendix E
Ensemble tissue harmonic imaging Note 2
Contrast agent imaging Note 7
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CONTINUE OFF WRITE BELOW THIS LINE-CONTINUE ON ANOTHER (ODE) r WRITE BELOW THIS LIRE CORNECE Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off) wision of Reproductive, Ah Padiological Devices December
21
510(k) Number (if known):
Device Name:
Intended Use:
V5Ms Phased Sector Array TEE Transducer for use with: ACUSON CV70 Cardiovascular System ACUSON CVTO Ourdlovation of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (Specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | P | P | P | P | P | P | P | BMDC | Note 2,3 | ||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA (K032111); E = added under Appendix E
Ensemble tissue harmonic imaging Note 2
3D imaging Note 3
(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 L. Brogdon
(Division Sign-Off)
Son of Repression
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | • | ||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | ||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA (K032111); 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)
Narrey C. Brogdon
(Division Sign-Off)
Division of Reproduc ve, Abdo and Radiological Devices 510(k) Number
23
510(k) Number (if known):
Device Name:
Intended Use:
CW5 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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA (K032111); 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)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdo and Radiological Devices : ! ')(k) Number __
24
510(k) Number (if known):
Device Name:
Intended Use:
P9-4 Phased Sector 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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | Note 2 | ||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2 | ||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | P | P | P | P | P | BMDC | Note 2 | |||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2 | ||
| Small Organ | P | P | P | P | P | P | BMDC | Note 2 | ||
| Neonatal Cephalic | P | P | P | P | P | P | BMDC | Note 2 | ||
| Adult Cephalic | P | P | P | P | P | P | BMDC | Note 2 | ||
| Cardiac | P | P | P | P | P | P | BMDC | Note 2,7 | ||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA (K042044); 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 C Hodgson
(Division Sign-Off)
Division of Reproductive, Abde and Radiological Devices
510(k) Number
25
510(k) Number (if known):
Device Name:
AcuNav 8F ultrasound catheter for use with: ACUSON CV70 Cardiovascular System
Intended Use:
ACUSUN CVTU Cardiovascular visualization of cardiac and great vessel intracardial and intravascular Visualization of other devices in the heart as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | N | N | BMDC | Note 2,7 | |
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | Note 2,7 | |||||||||
| Intravascular | N | N | N | N | N | N | N | BMDC | ||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) | N | N | N | N | N | N | N | BMDC | Note 2,3,7,8 |
- (spoon))
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Ensemble tissue harmonic imaging Note 2
3D imaging Note 3
Contrast agent imaging Note 7
Intracardiac Imaging Note 8
(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-O Division of Reproductive, Abdo and Radiological Devices 510(k) Number