ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K093531 |
|---|---|
| Device Name | ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Siemens Medi Cal Solutions, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Dec 1, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
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. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Device Story
ACUSON X300 is a multi-purpose diagnostic ultrasound system; utilizes various transducers (phased, convex, linear, TEE, intracardiac) to acquire ultrasound signals; transforms signals into diagnostic images and fluid flow data; used in clinical settings (radiology, cardiology, surgery) by trained healthcare professionals; provides anatomical measurements and analysis packages for clinical diagnosis; aids clinicians in visualizing internal structures and blood flow; benefits patients through non-invasive diagnostic assessment.
Clinical Evidence
Bench testing only. Modifications were verified and validated according to the company's design control process. No clinical data presented.
Technological Characteristics
Diagnostic ultrasound system; supports multiple transducer types (phased, convex, linear, TEE, intracardiac); complies with UL 60601-1, IEC 60601-2-37, AIUM/NEMA UD-2/UD-3, and ISO 10993-1 biocompatibility standards; includes proprietary software for image processing and analysis.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in 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.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Siemens Acuson X300 ultrasound system (K090276, K071036, K061946)
- Siemens Acuson X500 Ultrasound System (K061980)
- ACUSON X150 Ultrasound System (K081121)
- ACUSON X300 Diagnostic Ultrasound System, Premium Edition (K090276)
Related Devices
- K071036 — MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc., Ultrasound DI · May 16, 2007
- K080760 — ACUSON X300 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc., Ultrasound DI · Apr 25, 2008
- K072676 — ACUSON X300 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Dec 18, 2007
- K090276 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Feb 19, 2009
- K081121 — MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc., Ultrasound DI · Jun 4, 2008
Submission Summary (Full Text)
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K093531
ACUSON X300 ™ Diagnostic Ultrasound System 510(k) Submission
### 510(k) Summary
| Sponsor: | Siemens Medical Solutions, Inc.,<br>Ultrasound Division<br>1230 Shorebird Way<br>Mountain View, California 94043 | | | | | | | | | | | DEC - 1 2009 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------|--|--|--|--|--|--|--|--|--|--------------|
| Contact Person: | Shelly Pearce<br>Telephone: (650) 694-5988<br>Fax: (650) 694-5580 | | | | | | | | | | | |
| Submission Date: | October 06, 2009 | | | | | | | | | | | |
| Device Name: | ACUSON X300™ Diagnostic Ultrasound System | | | | | | | | | | | |
| 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-IYN | | | | | | | | | | |
| 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-DQ |
### 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 (K090276, K071036 and K061946) and the following:
- K061980, Siemens Acuson X500™ Ultrasound System ◆
- K081121, ACUSON X150 Ultrasound System ●
- · K090276, ACUSON X300™ Diagnostic Ultrasound System, Premium Edition
### B. Device Description:
The Acuson X300 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 제
- I CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- 로 AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 트 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive 트
- Safety and EMC Requirements for Medical Equipment
- « EN/IEC 60601-1
발
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- 트 EN/IEC 60601-1-1
- M EN/IEC 60601-1-2
- 내 EN/IEC 60601-1-4
- I EN/IEC 60601-1-6
- 피 EN/IEC 60601-2-18
- EN/IEC 60601-2-25 I
- IEC 1157 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.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
### 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.
### X300 510{k} Submission
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
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" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, facing to the right.
Public Health Service
DEC - 1 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
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: K093531
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 DOO Dated: November 13, 2009 Received: November 16, 2009
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the ACUSON X300™ Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
P4-2 Phased Sector Array CH5-2 Convex Array VF10-5 Linear Array L9-5 Linear Array EC9-4 Convex Array
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EV9-4 Convex Array VF13-5 Linear Array P8-4 Phased Sector Array BE9-4 Convex Array CW2 Continuous Wave Doppler CW5-Continuous Wave Doppler AcuNav 8F Intracardiac AcuNav 10F Intracardiac V5Ms TEE 4V1c Phased Sector Array VF13-5SP Linear Array C8-5 Tightly Curved Array 8L3 Linear "Regel" 10V4 Phased Array C7F2 Curved Array Mechanical 3D/4D EV9F4 Curved Array Mechanical 3D/4D L13F5 3D/4D Mechanical Wobbler Linear VF8-3 Linear Array P5-1 Phased Array C6-2 Convex Array SoundStar 10F P9-4 Phased Array P4-2 Litho Phased Sector Array BP9-4 Convex 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please
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note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely yours,
hozu h. Why
5 Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Indications for Use Statement
63531 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)
(Division Sign-
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
X300 510(k) Submission
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#### ACUSON X300™ Diagnostic Ultrasound System SIO(k) Submission
#### Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name: Intended Use: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|---------------------------|-------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------------|
| Other<br>(Track1<br>Only) | Specific<br>(Tracks11& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Fetal | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-operative<br>(Note 6) | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-operative<br>(Neuro) | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Fetal | Laparoscopic | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Pediatric | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Neonatal Cephalic | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-rectal | P | P | P | P | | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-vaginal | P | P | P | P | | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-urethral | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-esoph.<br>(non-Card.) | P | P | P | P | | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Musculo-skel.<br>(Convent.) | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Musculo-skel.<br>(Superfic) | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra -vascular | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Other<br>(Specify) | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Cardiac Adult | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11,12 |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-vascular<br>(Cardiac) | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-esophageal<br>(Cardiac) | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-Cardiac | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Other (Specify) | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11,12 |
| | Other (Specify) | P | P | P | P | P | P | P | P | BMDC | Note<br>2,3,4,5,7,8,9,11 |
N = new indication; P = proviously cleared by K090276
Nole 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging Note 3
Note 3 SD Imaging
Note 4 PWM BioScanner
andramara
B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 4
Note 5
Note 6 For example: abdominal, vascular
Note 7 Contrast agent imagi
Note 7
Note 8 Contrast agent imaging
SieClear multi-view spatial compounding
Note 9 Tissue Equalization Technology
Note 10
Note 11 Intracardiac Imaging
Dynamic TCE
Note 12 AHP
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Aomr Mz Wz
(Division Si roductive, Abdominal and
Page 38 of 1531
510(k) Number
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#### ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission
#### Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name: Intended Use:
P4-2 Phased Sector Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|-----------------------------|-------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Other<br>( Track 1<br>Only) | Specific<br>(Tracks11& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,5,6,7,8,9,11 |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal | Pediatric | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | | | | | | | | | | |
| | Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | |
| | Cardiac Adult | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Cardiac | Cardiac Pediatric | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | |
| | Trans-esophageal<br>(Cardlac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral | Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Vessel | Other (Specify) | | | | | | | | | | |
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2
Note 3
Ensemble lissue hamonic imaging
JD imaging
B&W SieScape panoramic imaging Note 4
Power SieScape panoramic imaging
For example: abdominal, vascular Note 5
Note 6
Note 6 For exemple: abdominal, vas
Note 7 Contrast agent imaging
Nole 7 Contrast agent imaging
SieClear multl-view spatial compounding
Tissue Equalization Technology Note 8
Note 9
Note 9 Tissue Equalization Technology
Note 10. Additional scans
Note 10 Intracardiac Imaging
Note 11 Dynamic TCE
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Aora M. Whay
(Division Sign-Division of Reproductive, Abdominal, and Radiological D
Page 39 of 1531
510(k) N
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ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
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 | | Mode of Operation | | | | | | | | | | |
|----------------------------|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|--|
| Other<br>( Track1<br>Only) | Specific<br>(Tracks1& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | |
| | Fetal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Abdominal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Intra-operative<br>(Note 6) | | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | |
| Fatal | Pediatric | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | P | P | P | | P | P | | BMDC | Note<br>2.3.4.5.7.8.9,11 | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | | |
| | Cardlac Adult | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| Cardlac | Cardiac Pedlatric | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | |
| Peripheral | Peripheral vessel | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| Vessel | Other (Specify) | | | | | | | | | | | |
N = new indication; P = prevlously cleared by K090276
Note 1
Note 2 For example: breast, testes, thyrold, penls, prostate, atc.
Ensemble tissue harmonic imaging
Note 3
Note 4 Note 5
2008. Imaging manoramic imaging
BBW Sging Siessape panoramic limaging
B&Wer SiesScape panoramic limaging
For example: abodominal, vascularing
Contrast agent imaging Note 6
Note 7
Note 8 SieClear multi-view spatial compounding
Note 9 Tissue Equalization Technology
Intracardiac imaging
Note 10
Note 11 Dynamic TCE
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concence of CDRH, Office of Device Evaluation (ODE)
> Concence of CDRH, Office of Device Evaluation (ODE)
.
---
(Division Sign-Off)
productive. Abdominal. Division of Re and Radiological Dev 510(k) Numbe
Page 40 of 1531
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ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
r
Intended Use:
ASHOON XSAC Di ACUSON X300 Dlagnostic Ultrasound Systems
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|-----------------------------|-------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------------|
| Other<br>(Track 1<br>Only) | Specific<br>(Tracks1& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | SmallOrgan<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Musculo-skel.<br>(Superfic) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-vascular | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | Note 12 |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11,12 |
| | Other (Specify) | | | | | | | | | | |
| | N = new indication: P = previously cleared by K090278 | | | | | | | | | | |
For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 1
Note 2
Note 3
Note 4
Rule 4 DAW Seascapes panoramic image
Note 6 Penna-Olga 1x6 U
3D imaging
B&W SieScape panoramic imaging
Power SleScape panoramic imaging
For example: abdominal, wascular
For example: abdominal, vascular
Contrast agent imaging Note S Note B
Note 7
Note 8
Note 9 SleClear multi-view spatial compounding
Tissue Equalization Technology
Intracardiac imaging
Note 10
Note 11
Note 12 Dynamic TCE
AHP
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CFR 801.109)
Ammal m. Why
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological De 510(k) Number
# Page 41 of 1531
{10}------------------------------------------------
ACUSON X300m Diagnostic Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
Intended Use:
L.9-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------------|
| Other<br>(Track 1<br>Only) | Specific<br>(Tracks11& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | SmallOrgan<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Musculo-skel.<br>(Superfic) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-vascular | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | Note 12 |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | |
| | Intra-Cardaic | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11,12 |
| | Other (Specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K090276
For example: breast, testes, thyrold, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic Imaging Note 3
Note 4
3D Imaging
B&W SieScape
3D imaging
B&W SieScape panoramic Imaging
Power SieScape panoramic Imaging Note 4
Note 5 Power SieScape panoramic Imaging
For example: abdominal, vascular
Nota 6
Note 7
Contrast agent imaging
SieClear multi-view spatlal compounding Note 8
Note 9
Note 10 Tissua Equalization Technology Intracardiac imaging
Note 11 Dynamic TCE
Note 12 AHP
> (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)
Aopai Th Way
(Division Si Division of Reproductive, Abdomina and Radiological Dev
Page 42 of 1531
510(k) Number
{11}------------------------------------------------
#### ACUSON X300™ Diagnostic Ultrasound System SIO(k) Submission
Dlagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
Intended Use:
EC9-4 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 | | Mode of Operation | | | | | | | | | |
|-----------------------------|-------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Other<br>( Track 1<br>Only) | Specific<br>(Tracks1& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | | | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric<br>SmallOrgan<br>(Note 1) | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Neonatal Cephalic | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-vaginal | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | |
| | Intra-Cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
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 f
- Note 7 Contrast agent imaging Note 8
- SieClear multi-view spatial compounding
Tissue Equalization Technology
- Note 9 Note 10 Intracardiac imaging
- Nole 11 Dynamic TCE
(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)
Lori M. Whay
(Divi Sign-Off Division of Reproductive, Abdominal, and Radiological De 510(k) Number
# Page 43 of 1531
{12}------------------------------------------------
ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
,'
,
Intended Use:
EV9-4 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 | | Mode of Operation | | | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Other<br>(Track1<br>Only) | Specific<br>(Tracks11& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | | | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | | | |
| | SmallOrgan<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-vaginal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | |
| | Intra-Cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K090276
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 Nole 4
Note 5 Power SieScape panoramic Imaging
For example: abdominal, vascular
Nota 6
Note 7
Note B
Contrast agent imaging
SieClear multi-view spatial compounding
Tissue Equalization Technology
Note 9
Note 10 Intracardiac imaging
Note 11 Dynamic TCE
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
> Concurrence Prescription Use (Per 21 CFR 801.109)
Tony M. Wieg
. .
(Division Reproductive, Abdominal, grid 510(k) N
# Page 44 of 1531
{13}------------------------------------------------
### ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission
### Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
VF13-5 Linear Array Transducer for use with:
Intended Use:
ACUSON X300 Diagnostic Ultrasound Systems
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | | | |
|-----------------------------|-------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------------|--|
| Other<br>( Track 1<br>Only) | Specific<br>(Tracks1i& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | |
| | Fetal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Abdominal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Intra-operative<br>(Note 6) | | | | | | | | | - | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | SmallOrgan<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note<br>2.3,4.5,7,8,9,11 | |
| | Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note<br>2.3,4,5,7,8,9,11 | |
| | Adult Cephalic | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Musculo-skel.<br>(Superfic) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Intra-vascular | | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | Note 12 | |
| | Cardiac Pediatric | | | | | | | | | | | |
| | Intra-vascular.<br>(Cardiac) | | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11,12 | |
| | Other (Specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by K090276
Note 1 For example: breast, testes, thyrold, penis, prostate, etc. Ensemble tissue harmonic imaging
Note 2 Note 3
3D imaging
B&W SieScape panoramic imaging Note 4
Note 5
Note 6 Power SieScape panoramic imaging
For example: abdominal, vascular
Note 7 Contrast agent imaging Note 8
SleClear multi-view spatial compounding
Tissue Equalization Technology Note 9
Intracardiac Imaging
Note 10
Note 11 Dynamic TCE
AHP
Note 12
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evalualion (ODE)
Prescription Use (Per 21 CFFR 801, 109)
Aorall M. Whing
Abdominal oductive and Ra
Page 45 of 1531
510(k) Numbe
{14}------------------------------------------------
#### ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name:
P8-4 Phased Sector Array Transducer for use with:
Intended Use:
ACUSON X300 Dlagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|--|
| Other<br>( Track 1<br>Only) | Specific<br>(Tracks11& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | |
| | Fetal | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Abdominal | | P | P | P | P | P | P | | BMDC | Note<br>2,3,5,6,7,8,9,11 | |
| | Intra-operative<br>(Note 6) | | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | |
| Fetal | Pediatric | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | | | | | | | | | | | |
| | Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Adult Cephalic | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | | |
| | Musculo-skel.<br>(Convent) | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | | |
| | Cardiac Adult | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| Cardiac | Cardiac Pediatric | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | |
| | Other (Specify) | | | | | | | |…
