← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K080760 # ACUSON X300 ULTRASOUND SYSTEM (K080760) _Siemens Medical Solutions USA, Inc., Ultrasound DI · IYN · Apr 25, 2008 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K080760 ## Device Facts - **Applicant:** Siemens Medical Solutions USA, Inc., Ultrasound DI - **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md) - **Decision Date:** Apr 25, 2008 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 892.1550 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Pediatric ## 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 (convex, phased, linear, endocavity, TEE, intracardiac) to acquire acoustic signals; transforms signals into B-mode, M-mode, Pulsed Wave Doppler, Continuous Wave Doppler, Color Doppler, and Amplitude Doppler images; supports advanced imaging modes including 3D/4D, panoramic imaging (SieScape), spatial compounding (SieClear), and tissue harmonic imaging; used in clinical settings (radiology, cardiology, surgery) by trained healthcare professionals; provides anatomical measurements and analysis packages to assist in clinical diagnosis; benefits patients through non-invasive visualization of internal structures and blood flow. ## Clinical Evidence Bench testing only. The device modifications were verified and validated according to the manufacturer's design control process. No clinical data was required for this 510(k) submission. ## Technological Characteristics Diagnostic ultrasound system; supports multiple transducer types (convex, phased, linear, TEE, intracardiac); energy source: electrical/ultrasonic; connectivity: standard ultrasound system interfaces; software: proprietary; safety standards: UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-2/UD-3, ISO 10993-1 (biocompatibility). ## Regulatory 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 ([K072676](/device/K072676.md)) - Siemens ACUSON X300 ultrasound system ([K071036](/device/K071036.md)) - Siemens ACUSON X300 ultrasound system ([K061946](/device/K061946.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Siemens Medical Solutions USA, Inc. Ultrasound Division CONFIDENTIAL APR 2 5 2008 K080760 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 Concu (Division Sign-Off) Division EASE 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 {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) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices Prescription Use (Per 21 CFR 801.109) 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 Concurrence of CDRH Prescription (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 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: |… --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K080760](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K080760) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com