(38 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The focus is on standard ultrasound imaging and measurement capabilities.
No
The device is described as an "ultrasound imaging system" intended for "clinical diagnosis purposes" and "Diagnostic imaging or fluid flow analysis," indicating its primary function is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system provides "analysis packages that provide information that is used for clinical diagnosis purposes" and is for "Diagnostic imaging or fluid flow analysis of the human body." Additionally, the "Device Description" mentions compliance with "IEC 60601-2-37 Diagnostic Ultrasound Safety Standards," further indicating its diagnostic function.
No
The device description explicitly states it is an "ultrasound imaging system" and lists numerous hardware safety standards (UL, IEC, CSA, etc.) that apply to physical medical equipment, not software-only devices.
Based on the provided information, the Siemens ACUSON X300 ultrasound imaging system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body). The ACUSON X300 is an ultrasound imaging system that performs diagnostic imaging and fluid flow analysis in vivo (within the body) by applying ultrasound waves to the patient.
- The Intended Use/Indications for Use clearly describe imaging applications on the human body. It lists various anatomical sites and applications like Fetal, Abdominal, Cardiac, etc., all of which involve imaging the patient directly.
- The Device Description focuses on safety standards related to medical equipment used on patients, not standards specific to laboratory testing or analysis of biological samples.
- There is no mention of analyzing biological specimens or performing tests on samples.
Therefore, the Siemens ACUSON X300 is a diagnostic imaging device used for in vivo examination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular 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.
ACUSON X300 Diagnostic Uitrasound SystemsIntended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:
Product codes (comma separated list FDA assigned to the subject device)
90-IYO, 90-IYN, 90-IYO, 90-ITX, 74-DQC, IYN, IYO, ITX, DQO
Device Description
The Siemens ACUSON X300 has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment
- I IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- I CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 1 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive
- . Safety and EMC Requirements for Medical Equipment
- 트 EN/IEC 60601-1
- 요 EN/IEC 60601-1-1
- 트 EN/IEC 60601-1-2
- 트 EN/EC 60601-1-4
- 이 EN/EC 60601-1-6
- . EN/IEC 60601-2-18
- 피 EN/EC 60601-2-25
- I IEC 61157 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
Fetal, Abdominal, Pediatric, Small Organ (e.g. breast, testes, thyroid, penis, prostate), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Intravascular, Peripheral vessel, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intraoperative (e.g. abdominal, vascular), Intra-cardiac
Indicated Patient Age Range
Neonatal, Pediatric, Adult
Intended User / Care Setting
Prescription Use
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)
The ACUSON X300 modifications are verified and validated according to the company's design control process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Siemens Medical Solutions USA, Inc. Ultrasound Division CONFIDENTIAL
APR 2 5 2008
ACUSON X300™ Ultrasound System Special 510(k) Submission
SECTION 12
510(k) Summary
| Sponsor: | Siemens Medical Solutions USA, Inc.,
Ultrasound Division
1230 Shorebird Way
Mountain View, California 94043 | |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------|
| Contact Person: | Martina Vogt
Telephone: (425) 557 1434
Fax: (425) 391 9198 | |
| Submission Date: | March 14, 2008 | |
| Device Name: | ACUSON X300™ ultrasound system
SONOVISTA X300 ultrasound system
ACUSON X300™ ultrasound system, premium edition | |
| Common Name: | Diagnostic Ultrasound System with Accessories | |
| Classification: | | |
| Regulatory Class: | II | |
| Review Category: | Tier II | |
| Classification Panel: | Radiology | |
| Ultrasonic Pulsed Doppler Imaging System FR #892-1550 | Product Code: 90-IYO | |
| 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 74-DQC |
A. Legally Marketed Predicate Devices
The Siemens ACUSON X300 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens ACUSON X300 ultrasound system (K072676, K071036, K061946).
B. Device Description:
The Siemens ACUSON X300 has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment
- I IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- I CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 1 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive
- . Safety and EMC Requirements for Medical Equipment
- 트 EN/IEC 60601-1
- 요 EN/IEC 60601-1-1
- 트 EN/IEC 60601-1-2
- 트 EN/EC 60601-1-4
1
- 이 EN/EC 60601-1-6
- . EN/IEC 60601-2-18
- 피 EN/EC 60601-2-25
- I IEC 61157 Declaration of Acoustic Power
- ISO 10993-1 Biocompatibility
C. Intended Use
The Siemens ACUSON X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
D. Substantial Equivalence
The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.
E. Performance Data
The ACUSON X300 modifications are verified and validated according to the company's design control process.
2
Image /page/2/Picture/1 description: The image shows the 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 emblem featuring a stylized eagle with outstretched wings, symbolizing the department's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Martina Vogt Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. Ultrasound Division 1230 Shorebird Way MOUNTAIN VIEW CA 94043
APR 2 5 2008
Re: K080760
Trade/Device Name: ACUSON X300 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and DQO Dated: March 14, 2008 Received: March 26, 2008
Dear Ms. Vogt:
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 X300 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
C6-2 Convex Array SoundStar 10F P4-2 Phased Sector Array CH5-2 Convex Array VF10-5 Linear Array
L9-5 Linear Array EC9-4 Convex Array Endocavity EV9-4Convex Array VF13-5 Linear Array P8-4 Phased Array
3
8L3 Linear "Regel" BE9-4 Convex Array CW2 Continuous Wave Doppler 10V4 Phased Array Neonatal High CW5 Continuous Wave Doppler Frequency C7F2 Curved Array AcuNav 8F Intracardiac EV9F4 Curved Array Mechanical 3D/4D AcuNav 10F IntraCardiac L13F5 3D/4D Mechanical Wobbler Linear V5Ms TEE 4V1c Phased Array VF8-3 Linear Array P5-1 Phased Array VF13-5SP Linear Array C8-5 Tightly Curved Array
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.
Sincerely yours,
Nancy C. Brogdon
Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
Indications for Use
510(k) Number (if known):
Device Name: _ACUSON X300 Diagnostic Ultrasound System
Indications For Use:
The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arri Mr. Wry
(Division Sign Off) (Division Sigipon)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
6
510(k) Number (if known):
Device Name:
ACUSON X300 Diagnostic Uitrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| 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 2,3,4,5,7,8,9 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Intraoperative
(Note 6) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Intraoperative
Neurological | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Small Organ
(Note 1) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transesophageal | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9 |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transurethral | | | | | | | | | | |
| Intravascular | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Musculo-skeletal
Superficial | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Other (specify) | | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 |
N = new indication; P = previously cleared by K072676; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
SieClear multi-view spatial compounding Note B
Tissue Equalization Technology Note 9
Note 10 Intracardiac imaging
(Division Sign-Off
(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)
Prescription Use (Per 21 CFR 801.109)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K08074
7
510(k) Number (if known):
Device Name:
C6-2 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
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 | N | N | N | N | N | BMDC | Note | |||
| 2,3,4,5,7,8,9 | ||||||||||
| Abdominal | N | N | N | N | N | BMDC | Note | |||
| 2,3,4,5,7,8,9 | ||||||||||
| Intraoperative | ||||||||||
| (Note 6) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | N | N | N | N | N | BMDC | Note | |||
| 2,3,4,5,7,8,9 | ||||||||||
| Small Organ (Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | BMDC | Note | |||
| 2,3,4,5,7,8,9 | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | N | N | N | N | N | BMDC | Note | |||
| 2,3,4,5,7,8,9 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | N | N | N | N | N | BMDC | Note | |||
| 2,3,4,5,7,8,9 | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| 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.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular Note 7
Contrast agent imaging Note 8
SieClear multi-view spatial compounding Note 9
Tissue Equalization Technology
Note 10 Intracardiac imaging
(Division Sign-Off)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Ber 21 CER 801 1001
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Section 6
Prescription Use (Per 21 CFR 801.109)
8
510(k) Number (if known):
Device Name:
SoundStar 10F Transducer for use with:
Intended Use:
ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follow:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude Doppler | Color | |||||||||
| Velocity | |||||||||||
| Imaging | Combine | ||||||||||
| d | |||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (Note 6) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Note 1) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | N | N | N | BMDC | Note | |||
| 2,3,7,8,9,10 | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | N | N | N | N | N | N | BMDC | Note | |||
| 2,3,7,8,9,10 | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal (Superficial) | |||||||||||
| Other (intra-cardiac) | N | N | N | N | N | N | BMDC | Note | |||
| 2,3,7,8,9,10 |
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
Note 5 Power SieScape panoramic imaging
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
Note 8 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 9
Note 10 Intracardiac 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)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices K080 760 510(k) Number _
Section 6
9
510(k) Number (if known):
Device Name:
Intended Use:
P4-2 Phased Sector Array Transducer for use with: ACUSON X300 Diagnostic Uitrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
Mode of Operation Clinical Application Color Amplitude Color PWD Combined Other A B ખ CWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal P P P P P P BMDC Note 2,3,4,5,7,8,9 Abdominal P P P P P P BMDC Note 2,3,5,6,7,8,9 Intraoperative (Note 6) Intraoperative Neurological Pediatric P P P P P P BMDC Note 2,3,4,5,7,8,9 Small Organ (Note 1) Neonatal Cephalic P P P P P P Note 2,3,4,5,7,8,9 BMDC Adult Cephalic P P P P P P BMDC Note 2,3,4,5,7,8,9 Cardiac P P P P P P BMDC Note 2,3,4,5,7,8,9 Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P p P P P P BMDC Note 2,3,4,5,7,8,9 Laparoscopic Musculo-skelatal Conventional Musculo-skeletal Superficial Other (specify)
N = new indication; P = previously cleared by K072676; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
SieClear multi-view spatial compounding Note 8
Note 9 Tissue Equalization Technology
Note 10 Intracardiac 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)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Badiological Daui
Radiological Devices 510(k) Number
Section 6 Diagnostic Ultrasound Indications for Use Form
Pg. 6.4 of 6.29
10
510(k) Number (if known):
Device Name:
Intended Use:
CH5-2 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
Diagnostic imaging or fluid flow analysis of the human body as follows:
| 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 2,3,4,5,7,8,9 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Intraoperative
(Note 6) | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Small Organ
(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMDC | Note 2.3.4.5.7.8.9 |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K072676; 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
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
- Note 6 For example: abdominal, vascular
Contrast agent imaging Note 7
SieClear multi-view spatial compounding Note 8
Tissue Equalization Technology Note 9
Intracardiac imaging Note 10
(PLEASE DO NOT WRITE
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Division
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510(k) Number K080760
11
510(k) Number (if known):
Device Name:
İntended Use:
VF10-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
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 2,3,4,5,7,8,9 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Intraoperative | ||||||||||
| (Note 6) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Musculo-skeletal | ||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Other (specify) |
N = new indication; P = previously cleared by K072676; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Note 8 SieClear multi-view spatial compounding
Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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(Division Sign-Off)
Division of Reproductive, Abdominal and
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Radiological Devices
510(k) Number K080760
Section 6
12
510(k) Number (if known):
Device Name:
L9-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
Intended Use:
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 2.3.4.5.7.8.9 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Intraoperative | ||||||||||
| (Note 6) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Musculo-skeletal | ||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Other (specify) |
N = new indication; P = previously cleared by K072676; 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
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
SieClear multi-view spatial compounding Note 8
Tissue Equalization Technology Note 9
Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW TH
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(Division Sign-Off)
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510(k) Number K080760
Section
13
510(k) Number (if known):
Device Name:
EC9-4 Convex Array Endocavity Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| 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 2,3,4,5,7,8,9 |
| Abdominal | | | | | | | | | | |
| Intraoperative
(Note 6) | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K072676; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Nota 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Contrast agent imaging Note 7
SieClear multi-view spatial compounding Note 8
- Tissue Equalization Technology Note 9
Note 10 Intracardiac 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 K080760
Prescription Use {Per 21 CFR 801.109}
Radiological Devices
(K) Number
K080760
Section 6
D
14
Siemens Medical Solutions USA, Inc. Ultrasound Division CONFIDENTIAL
ACUSON X300™ Ultrasound System Special 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
EV9-4 Convex Array Transducer for use with:
Intended Use:
ACUSON X300 Diagnostic Ultrasound Systems 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 2,3,4,5,7,8,9 | |||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| (Note 6) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Transvaginal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K072676; 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 SleScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
SieClear multi-view spatial compounding Note 8
- Tissue Equalization Technology Note 9
Note 10 Intracardiac imaging
ASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Reproductive. Abdominal a Radiological De 510(k) Number
Section 6
Prescription Use (Per 21 CFR 801.109)
15
510(k) Number (if known):
Device Name:
VF13-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems 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 | BMDC | Note 2.3.4.5.7.8.9 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Intraoperative | ||||||||||
| (Note 6) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Musculo-skeletal | ||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Other (specify) |
N = new indication; P = previously cleared by K072676; 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
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Contrast agent imaging Note 7
Note 8 SieClear multi-view spatial compounding
- Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
Horner Thayer
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080760
Prescription Use (Per 21 CFR 801.109)
cal Device
Number K080 760
Section 6
16
510(k) Number (if known):
Device Name:
Intended Use:
P8-4 Phased Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
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 2,3,4,5,7,8,9 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,45,7,8,9 | |||
| Intraoperative | ||||||||||
| (Note 6) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Small Organ | ||||||||||
| (Note 1) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K072676; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaoing
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Note 8 SieClear multi-view spatial compounding
- Tissue Equalization Technology Note 9
Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Divisio Division of Reproductive, Abdominal and Radiological Devic
Section 6
510(k) Number
Prescription Use (Per 21 CFR 801,109)
17
510(k) Number (if known):
Device Name:
Intended Use:
BE9-4 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
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 | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| (Note 6) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Transvaginal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K072676; E = added under Appendix E
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Ensemble tissue harmonic imaging Note 2
Nota 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
SieClear multi-view spatial compounding Note 8
Tissue Equalization Technology Note 9
Note 10 Intracardiac 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 K080760
Section 6 Diagnostic Ultrasound Indications for Use Form Pg. 6.12 of 6.29
Prescription Use (Per 21 CFR 801.109)
18
510(k) Number (if known):
Device Name:
CW2 Continuous Wave Doppler Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
Intended Use:
Mode of Operation Clinical Application Color Color Amplitude Combined Other A B M PWD CWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal P Abdominal P Intraoperative P (Note 6) Intraoperative Neurological Pediatric P Small Organ P (Note 1) Neonatal Cephalic P Adult Cephalic P Cardiac P Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P Laparoscopic Musculo-skeletal P Conventional Musculo-skeletal Superficial Other (specify)
N = new indication; P = previously cleared by K072676; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
3D imaging Note 3
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
Note 8 SieClear multi-vlew spatial compounding
Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
(Division Sign-Off)
(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 of Reproductive, Abdominal and
Radiological Devices
510(k) Number
Section 6
19
510(k) Number (if known):
Device Name:
CW5 Continuous Wave Doppler Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
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 | P | |||||||||
| Abdominal | P | |||||||||
| Intraoperative | ||||||||||
| (Note 6) | P | |||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | |||||||||
| Small Organ | ||||||||||
| (Note 1) | P | |||||||||
| Neonatal Cephalic | P | |||||||||
| Adult Cephalic | P | |||||||||
| Cardiac | P | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethrai | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | |||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
= new indication; P = previously cleared by K072676; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaqino
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Note 8 SleClear multi-view spatial compounding
Note 9 Tissue Equalization Technology
Note 10 Intracardiac 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 K080760
Prescription Use (Per 21 CFR 801.109)
Section 6
20
510(k) Number (if known):
Device Name:
AcuNav 8F Intracardiac Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems
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) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,7,8,9,10 | |||
| Small Organ | |||||||||||
| (Note 1) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardlac | P | P | P | P | P | P | BMDC | Note 2,3,7,8,9,10 | |||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | P | P | P | P | P | P | BMDC | Note 2,3,7,8,9,10 | |||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (Intra-cardiac) | P | P | P | P | P | P | BMDC | Note 2,3,7,8,9,10 |
N = new indication; P = previously cleared by K072676; 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
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
SieClear multi-view spatial compounding Note 8
Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
SE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-
Prescription Use (Per 21 CFR 801.109)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080760
Section 6
21
510(k) Number (if known):
Device Name:
AcuNav 10F Intracardiac Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems
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) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,7,8,9,10 | ||
| Small Organ | ||||||||||
| (Note 1) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | BMDC | Note 2,3,7,8,9, 10 | ||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | P | P | P | P | P | P | BMDC | Note 2,3,7,8,9,10 | ||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (Intra-cardiac) | P | P | P | P | P | P | BMDC | Note 2,3,7,8,9,10 |
N = new indication; P = previously cleared by K072676; 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
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
Note 8 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 9
Note 10 Intracardiac imaging
(Division Sign-Off
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Gregoription Joo (Bor 31 CER 901 1001
Prescription Use (Per 21 CFR 801.109)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Section 6
22
510(k) Number (if known):
Device Name:
V5Ms TEE Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
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) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (Note 1) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | BMDC | Note 2,3,7,8,9 | |||
| Transesophageal | P | P | P | P | P | P | BMDC | Note 2,3,7,8,9 | |||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K072676; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
3D imaging Note 3
Section 6
Note 4 B&W SieScape panoramic imaging
Note 2 Power SieScape panoramic imaging
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
Note 8 SieClear multi-view spatial compounding
Note 9 Tissue Equalization Technology
Note 10 Intracardiac 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)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080760
23
510(k) Number (if known):
Device Name:
4V1c Phased Array Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| 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 | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Abdominal | P | P | P | P | P | P | P | | BMDC | Note 2,3,5,6,7,8,9 |
| Intraoperative
(Note 6) | | | | | | | | | | Note 2,3,5,6,7,8,9 |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Small Organ
(Note 1) | | | | | | | | | BMDC | Note 2,3,4,5,7,8,9 |
| Neonatal Cephalic | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Adult Cephalic | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Cardiac | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K072676; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6 Note 7
Contrast agent imaging
SieClear multi-view spatial compounding Note 8
Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
A 12 A PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Reproductive, Abdominal and Radiological Devices
Prescription Use (Per 21 CFR 801.109)
Radiological Devices
510(k) Number K080760
24
510(k) Number (if known):
Device Name:
Intended Use:
ACUSON X30
VF13-5SP Linear Array Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems 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 2,3,4,5,7,8,9 | ||||
| Intraoperative | |||||||||||
| Neurological | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | ||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | ||||
| Small Organ | |||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | ||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | ||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | ||||
| Musculo-skeletal | |||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | ||||
| Other (specify) |
N = new indication; P = previously cleared by K072676; 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
Section 6
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
SieClear multi-view spatial compounding Note 8
Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
(Division Sign-Off) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Division of Reproductive, Abdominal and Concurrence of CDRH, Office of Device Evaluation (ODE)
Dedislegiael Dovings Prescription Use (Per 21 CFR 801.109)
Radiological Devices 510(k) Number _
1-800-4-MY-HOME®
25
510(k) Number (if known):
Device Name:
Intended Use:
C8-5 Tightly Curved Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
Mode of Operation Clinical Application Color Color Amplitude Combined Other A B M PWD CWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal P P P P P BMDC Note 2,3,4,5,7,8,9 Abdominal P p P P P BMDC Note 2,3,5,6,7,8,9 Intraoperative (Note 6) Intraoperative Neurological Pediatric P P P P P BMDC Note 2,3,4,5,7,8,9 Small Organ P P P P P BMDC Note 2,3,4,5,7,8,9 (Note 1) Neonatal Cephalic P P P P P BMDC Note 2,3,4,5,7,8,9 Adult Cephalic P P P P P BMDC Note 2,3,4,5,7,8,9 Cardiac p P P P P BMDC Note 2,3,4,5,7,8,9 Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P P P P P BMDC Note 2,3,4,5,7,8,9 Laparoscopic Musculo-skeletal P P P P P BMDC Note 2,3,4,5,7,8,9 Conventional Musculo-skeletal P P P P P BMDC Note 2,3,4,5,7,8,9 Superficial Other (specify)
N = new indication; P = previously cleared by K072676; 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
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Contrast agent imaging Note 7
SieClear multi-view spatial compounding Note 8
Tissue Equalization Technology Note 9
Note 10 Intracardiac 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)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K080760
26
510(k) Number (if known):
Device Name:
Intended Use:
8L3 Linear "Regel" Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems 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 2,3,4,5,7,8,9 | |||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||||
| Intraoperative | ||||||||||||
| (Note 6) | ||||||||||||
| Intraoperative | ||||||||||||
| Neurological | ||||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||||
| Small Organ | ||||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||||
| Musculo-skeletal | ||||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||||
| Other (specify) |
N = new Indication; P = previously cleared by K072676; 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
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
Note 8 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 9
Note 10 Intracardiac imaging
Haya N. Atter
CEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 1680 the
Prescription Use (Per 21 CFR 801.109)
Radiological Devices
(Division Sign-Off
27
510(k) Number (if known):
Device Name:
10V4 Phased Array Neonatal High Frequency Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
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 | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,45,7,8,9 | |||
| Intraoperative | ||||||||||
| (Note 6) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Small Organ | ||||||||||
| (Note 1) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K072676; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Note 8 SieClear multi-view spatial compounding
Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
Division Sign-Off)
LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Goneurrence of CDRH, Office of Device Evaluation (ODE)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080760
Prescription Use (Per 21 CFR 801.109)
Diagnostic Ultrasound Indications for Use Form
28
510(k) Number (if known):
Device Name:
C7F2 Curved Array Mechanical 3D/4D Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
Intended Use:
Mode of Operation Clinical Application Color Color Amplitude Combined A B PWD CWD Other M Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal P P P P P BMDC Note 2,3,4,5,7,8,9 Abdominal P P പ്ര P b BMDC Note 2,3,4,5,7,8,9 Intraoperative (Note 6) Intraoperative Neurological Pediatric P P P b P BMDC Note 2,3,4,5,7,8,9 Small Organ (Note 1) Neonatal Cephalic Adult Cephalic Cardiac P P P P P BMDC Note 2,3,4,5,7,8,9 Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P P P P P BMDC Note 2,3,4,5,7,8,9 Laparoscopic Musculo-skeletal P P P P P BMDC Conventional Note 2.3.4.5.7.8.9 Musculo-skeletal Superficial . Other (specify)
N = new indication; P = previously cleared by K072676; 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
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
· SieClear multi-view spatial compounding Note 8
Note 9 Tissue Equalization Technology Note 10 Intracardiac 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)
510/k) Numb
Division of Reproductive, Abdominal and
29
510(k) Number (if known):
Device Name:
EV9F4 Curved Array Mechanical 3D/4D Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems
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 | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| (Note 6) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Transvaginal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K072676; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Power SleScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
Note 8 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 9
Note 10 Intracardiac 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
Prescription Use (Per 21 CFR 801.109)
Division of Representa
Radiological Devices
510(k) Number
30
510(k) Number (if known):
Device Name:
.
Intended Use:
L13F5 3D/4D Mechanical Wobbler Linear Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
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 | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||||||||||||
| Intraoperative | ||||||||||||||||||||
| (Note 6) | ||||||||||||||||||||
| Intraoperative | ||||||||||||||||||||
| Neurological | ||||||||||||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||||||||||||
| Small Organ | ||||||||||||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||||||||||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||||||||||||
| Adult Cephalic | ||||||||||||||||||||
| Cardiac | ||||||||||||||||||||
| Transesophageal | ||||||||||||||||||||
| Transrectal | ||||||||||||||||||||
| Transvaginal | ||||||||||||||||||||
| Transurethral | ||||||||||||||||||||
| Intravascular | ||||||||||||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||||||||||||
| Laparoscopic | ||||||||||||||||||||
| Musculo-skeletal | ||||||||||||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||||||||||||
| Musculo-skeletal | ||||||||||||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K072676; 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
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
Note 6 For example: abdominal, vascular
Contrast agent imaging Note 7
Note 8 SieClear multi-view spatial compounding
Note 9 Tissue Equalization Technology
Note 10 Intracardiac 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 | K080760 |
| Section 6 |
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| Diagnostic Ultrasound Indications for Use Form | Pg. 6.25 of 6.2 |
31
510(k) Number (if known):
Device Name:
VF8-3 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
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 | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Intraoperative | ||||||||||
| (Note 6) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Musculo-skeletal | ||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | |||
| Other (specify) |
N = new indication; P = previously cleared by K072676; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic Imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
SieClear multi-view spatial compounding Note B
Tissue Equalization Technology Note 9
Note 10 Intracardiac 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)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080760
Section 6
32
510(k) Number (if known):
Device Name:
Intended Use:
P5-1 Phased Array Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems
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 | P | BMDC | Note 2,3,4,5,7,8,9 | ||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,5,6,7,8,9 | ||
| Intraoperative | ||||||||||
| (Note 6) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | ||
| Small Organ | ||||||||||
| (Note 1) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | ||
| Adult Cephalic | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | ||
| Cardiac | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | ||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,9 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by K072676; E = added under Appendix E
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging
Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging
SieClear multi-view spatial compounding Note 8
Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
(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 of Reproductive, Abdominal and
Radiological Devices
| 510(k) Number | K080760 |
|---|---|
| --------------- | --------- |
Section 6 Diagnostic Ultrasound Indications for Use Form Pg. 6.27 of 6.29