(83 days)
No
The summary describes a standard ultrasound system with various imaging modes and software features for venous measurements. There is no mention of AI, ML, or related technologies.
No.
The document clearly states that Esaote's Model 7340 is "used to perform diagnostic general ultrasound studies," indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used to perform diagnostic general ultrasound studies." The "Device Description" also reiterates that it is a "portable ultrasound system used to perform diagnostic general ultrasound studies."
No
The device description clearly states it is a "portable ultrasound system" with hardware components like a display, keyboard, probes, hard disk, DVD-RW drive, and optional accessories like a video recorder and printer. While it includes software features, it is fundamentally a hardware device with integrated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Esaote Model 7340 is an ultrasound system. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use describes performing diagnostic general ultrasound studies on various anatomical sites. This is consistent with an imaging device, not an IVD.
Therefore, the Esaote Model 7340 is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Esaote’s Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculo-skeletal applications. The 7340 system provides imaging for venous system measurements.
Product codes
90IYN, 90IYO, 90ITX
Device Description
Model 7340 is a portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The 7340 is equipped with a LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and onscreen annotations. The 7340 can drive phased (PA), convex (CA), linear array (LA), Doppler probes and BiScan probes. The 7340 is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (hard-disk, PC, server) via a LAN/USB port. Optional accessory devices available for the 7340 include an S-VHS video recorder; a monochrome or color page printer and a mobile trolley equipped with an insulation transformer. Model 7340 can be equipped with an internal battery that provides power when no main power is available.
The 7340 system has been cleared by FDA via K081794 and K091009.
Model 7340 upgrade, defined herein, combines the features of the Model 7340 with other, previously cleared software features and new software capabilities to assist a physician in making venous measurements. The venous imaging software package includes:
-
- Dedicated Presets for Venous System Imaging, CFM and Doppler
-
- QDP Quality Doppler Profiles Technology based on Multigate Doppler algorithm
-
- Optimized Probe management for Venous Intracranial Doppler
The 7340 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs (includes Breast, Thyroid and Testicles), Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic, Urologic.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Verification and validation tests have been conducted in accordance with design controls per CFR 820.30.
The system has been designed to meet the following standards:
- IEC 60601-1 .
- IEC 60601-1-2
- IEC 60601-2-37 .
- ISO 10993-1 .
- AIUM/NEMA UD-3 - Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2 Acoustic Output Measurement Standard for Diagnostic Ultrasound
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K032875, K033311, K003739, K040719
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
510(k) Summary Model 7340 Upgrade Esaote, S.p.A.
K110688
Page 1 of 3
JUN - 2 2011
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).
807.92(a)(1)
Submitter Information
Esaote S.p.,A Via di caciolle 15 50127 Firenze Italy
| Contact Person: | Allison Scott
317.569.9500 x106
ascott@ansongroup.com |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | February 7, 2011 |
| 807.92(a)(2) | |
| Trade Name: | Model 7340 upgrade |
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic pulse Doppler imaging system 892.1550
Ultrasonic pulsed echo imaging system 892.1560
Diagnostic ultrasonic transducer 892.1570 |
| Classification Number: | 90IYN, 90IYO, 90ITX |
| 807.92(a)(3) | |
| Predicate Device(s) | |
| K081794 and K091009 | 7340 Esaote, S.p.A. |
| K032875 and K033311 | SD5500 Aloka |
4000
Aloka
1
K1/0688
Page 2 of 3
510(k) Summary Model 7340 Upgrade Esaote, S.p.A.
807.92 (a)(4)
Device Description
Model 7340 is a portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The 7340 is equipped with a LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and onscreen annotations. The 7340 can drive phased (PA), convex (CA), linear array (LA), Doppler probes and BiScan probes. The 7340 is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (hard-disk, PC, server) via a LAN/USB port. Optional accessory devices available for the 7340 include an S-VHS video recorder; a monochrome or color page printer and a mobile trolley equipped with an insulation transformer. Model 7340 can be equipped with an internal battery that provides power when no main power is available.
The 7340 system has been cleared by FDA via K081794 and K091009.
Model 7340 upgrade, defined herein, combines the features of the Model 7340 with other, previously cleared software features and new software capabilities to assist a physician in making venous measurements. The venous imaging software package includes:
-
- Dedicated Presets for Venous System Imaging, CFM and Doppler
-
- QDP Quality Doppler Profiles Technology based on Multigate Doppler algorithm
-
- Optimized Probe management for Venous Intracranial Doppler
The 7340 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
807.92(a)(5)
Intended Use(s)
Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculo-skeletal applications. The 7340 system provides imaging for venous system measurements.
2
Image /page/2/Picture/0 description: The image shows handwritten text on a white background. The text includes the identifier "K110688" on the first line, followed by "Page 3 of 3" on the second line. The handwriting appears to be cursive and slightly slanted.
510(k) Summary Model 7340 Upgrade Esaote, S.p.A.
807.92(a)(6)
Technological Characteristics
The 7340 model has been cleared via K081794 and K091009. The Aloka SD5500 system has been cleared via K032875 and K033311; the Aloka 4000 has been cleared via K003739 and K040719.
- · Clinical uses for which the 7340 is designed are not changed by the 7340 upgrade, to be cleared via this submission.
- · Clinical uses for which the Esaote 7340 and 7340 upgrade systems are designed are equivalent to those of the Aloka SD5500 ultrasound system, cleared via K032875 and K033311 and of the Aloks 4000 cleared via k K003739 and K040719.
- · Esaote 7340 and 7340 upgrade, the Aloka SD5500 and Aloka 4000 ultrasound systems are able to provide the profile of the flow of the vessels under exam. The Aloka SDS500 system has been cleared via K032875 and K033311; the Aloka 4000 has been cleared via K003739 and K040719.
- · Esaote 7340 and 7340 upgrade, Aloka SD5500 and Aloka 4000 ultrasound systems are designed to meet the IEC60601-1 and IEC60601-2-37.safety requirements.
- · Esaote 7340 and 7340 upgrade, Aloka SD5500 and Aloka 4000 ultrasound systems provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values. ******************************************************************************************************************************************************************************
807.92(b)(1)
Non-Clinical Testing
Verification and validation tests have been conducted in accordance with design controls per CFR 820.30.
The system has been designed to meet the following standards:
- IEC 60601-1 .
- IEC 60601-1-2 ●
- IEC 60601-2-37 .
- ISO 10993-1 .
- AIUM/NEMA UD-3 - Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2 Acoustic Output Measurement Standard for Diagnostic � Ultrasound
3
Image /page/3/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 abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Esaote, S.p.A. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
JUN - 2 2011
Re: K110688
Trade/Device Name: 7340 Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 17, 2011 Received: May 18, 2011
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 7340 Ultrasound Systems, as described in your premarket notification:
Transducer Model Number
| PA230 | LA523 | CA621 | TRT33 |
|---|---|---|---|
| PA240 | LA532 | CA631 | TEE022 |
| PA121 | C5-2 R13 | 2 CW | TEE122 |
| PA122 | CA123 | 5CW | TEE132 |
| PA023 | CA421 | HF CW | IOE323 |
| LA332 | CA1421 | E8-5 R10P | LP323 |
| LA424 | CA430 | EC123 | BS230 |
| LA435 | CA431 | EC1123 | BC431 |
| LA522 | CA531 | BE1123 | BL433 |
4
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 895. 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 (OS) 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.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please 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 Joshua Nipper at (301) 796-6524.
Sincerely Yours,
Mary S Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
5
Indications for Use Statement
Model 7340
Indications for Use
510(k) Number (if known):
Device Name:
7340 Ultrasound Systems
Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculo-Skeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculo-Skeletal applications. The 7340 system provides imaging for venous system flow profile.
Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Patil
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110688
6
Mod.7340 upgrade
Intended use: Diagnostic uitrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| [3] | Tissue | ||||||||||
| Velocity | |||||||||||
| Mapping | |||||||||||
| (TVM) | Tissue | ||||||||||
| Enhancement | |||||||||||
| Imaging (TEI) | Other (specify) | ||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P | P | P | P: 4, 5, 6, 7, 8, 9, 10, 13 | ||
| Abdominal | P | P | P | P | P | P | P | P | P: 4, 5, 6, 7, 8, 9, 13 | ||
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13 | ||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P: 4, 5, 6, 7, 8, 9, 13 | ||
| Small Organ [1] | P | P | P | P | P | P | P | P | P: 4, 5, 6, 7, 8, 9, 13, 14 | ||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | ||
| Adult Cephalic | P | P | P | P | P | P | P | P | P: 6, 8, 9; N: 15 | ||
| Cardiac [2] | P | P | P | P | P | P | P | P | P[16] | P: 4, 5, 6, 7, 8, 9, 11, 12 | |
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | P | P | P: 4, 6, 9, 11, 12 | |
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | P | P | P | P | P | P | P | P | P: 4, 5, 6, 7, 8, 9, 13, 14 | ||
| Transvaginal | P | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 9, 14 | ||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P: 4, 5, 6, 7, 8, 9, 10, 12, 13; N: 15 | ||
| Laparoscopic | P | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13 | ||
| Musculo-skeletal Conventional | |||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P | P: 4, 5, 6, 7, 8, 9, 13, 14 | ||
| Musculo-skeletal Superficial | |||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P | P: 4, 5, 6, 7, 8, 9, 13, 14 | ||
| Other (Urological) | P | P | P | P | P | P | P | P | P: 4, 5, 6, 7, 8, 9, 13 |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [5] | MView |
| [6] | 3D |
| [7] | 4D |
| [8] | VPan |
| [9] | XView |
| [10] | QIMT |
| [11] | Stress |
| [12] | Strain |
| [13] | TP View |
| [14] | ElaXto |
| [15] | Quality Doppler Profile (QDP) |
Mary Slostel
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110688
[16] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border
Previously cleared via K081794 and
K091009
7
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhacement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | P | P | P: 6, 8, 9 | |
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P: 6. 8, 9 | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P[16] | P: 4, 6, 8, 9, 11, |
| 12 | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional (including | ||||||||||
| Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial (including | ||||||||||
| Nerve Blocking) | ||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles | (Division
Division of Rad
Office of In Vitro Diagnostic
510K |
|------|-----------------------------------------------------|-----------------------------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric | |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD | |
| [4] | CMM | |
| [6] | 3D | |
| [8] | VPan | |
| [9] | XView | |
| [11] | Stress | |
| [12] | Strain | |
Mary Scott
Sign-Off) ological Devices Device Evaluation and Safety
K110688
510K
[16] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border
8
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | P | P | P: 8, 9 | |
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P: 8, 9; N: 15 | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P[16] | P: 4, 8, 9, 11, 12 |
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial (including | ||||||||||
| Nerve Blocking) | ||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [8] | VPan |
| [9] | XView |
| [11] | Stress |
| [12] | Strain |
| [15] | Quality Doppler Profile (QDP) |
| [16] | Includes contrast (CnTi) in Adult Cardiac for left ventricle opacification and visualization |
of the left ventricular endocardial border
Mary Sfotel
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110688
9
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhacement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | P | P | P: 8, 9 | |
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | P | P | P | P | P | P | P | P | P: 4, 8, 9, 11, | |
| 12 | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [8] | VPan |
| [9] | XView |
| [11] | Stress |
| [12] | Strain |
Mary S/otd
Division of Radiological Devices Office of In Vitro Diag Evaluation and Safety
510K K110688
10
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P: 6, 8, 9 | |
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P: 6, 8, 9 | |
| Adult Cephalic | ||||||||||
| Cardiac [2] | P | P | P | P | P | P | P | P | P | P: 4, 6, 8, 9, 11, |
| 12 | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P: 6, 8, 9, 12 | |
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [11] | Stress |
Strain
(12)
May S. Patel
(Division Sign-Off)
Division of Radiological Devices Office of in Vitro Diagnostic Device Evaluation and Safety
510K 110688
11
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| [3] | Tissue | ||||||||||
| Velocity | |||||||||||
| Mapping | |||||||||||
| (TVM) | Tissue | ||||||||||
| Enhacement | |||||||||||
| Imaging (TEI) | Other (specify) | ||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 8, 9 | |||
| Small Organ [1] | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P: 8, 9 | |||
| Adult Cephalic | |||||||||||
| Cardiac (2) | P | P | P | P | P | P | P | P: 4, 8, 9, 11, 12 | |||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 8, 9 | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| (including Nerve Blocking) | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| (including Nerve Blocking) | |||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [8] | VPan |
| [9] | XView |
| [11] | Stress |
| [12] | Strain |
Division of Radiological Devices Office of In Vitro Diagnos aluation and Safety
510K K110C688
Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)
:
12
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| [3] | Tissue | ||||||||||
| Velocity | |||||||||||
| Mapping | |||||||||||
| (TVM) | Tissue | ||||||||||
| Enhancement | |||||||||||
| Imaging (TEI) | Other (specify) | ||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13 | |||
| Small Organ [1] | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13, 14 | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 10, 12, 13; N: 15 | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13 | |||
| Musculo-skeletal Superficial | |||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13 | |||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles | |
|---|---|---|
| [2] | Cardiac is Adult and Pediatric | |
| [3] | Combined modes are: B + M + PW + CFM + PD | |
| [4] | CMM | |
| [5] | MView | |
| [6] | 3D | |
| [8] | VPan | |
| [9] | XView | |
| [10] | QIMT | |
| [12] | Strain | Office of |
| [13] | TP View | |
| [14] | ElaXto | 510K |
| [15] | Quality Doppler Profile (QDP) |
Mary Stotl
(Division Sign-Off)
Division of Radiological Devices fice of In Vitro Diagnostic Devices
fice of In Vitro Diagnostic Device Evaluation and Safety
510K. K110688
13
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| [3] | Tissue | ||||||||||
| Velocity | |||||||||||
| Mapping | |||||||||||
| (TVM) | Tissue | ||||||||||
| Enhacement | |||||||||||
| Imaging (TEI) | Other (specify) | ||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, | ||||
| 13 | |||||||||||
| Small Organ [1] | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, | ||||
| 13 | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, | ||||
| 12, 13 | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, | ||||
| 13 | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, | ||||
| 13 | |||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Strain
TP View
Previously cleared via K091009
(1)
(2)
[3]
(4)
ાંટો
រេរវា
। 1 ओ
Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CFM + PD CMM
MVicw
- ાંઠા 3D (8] VPan ત્વે XVicw
Mary S. Potter
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110688
14
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
[3] | Tissue
Velocity
Mapping
(TVM) | Tissue
Enhancement
Imaging (TEI) | Other (specify) |
|-------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|----------------------------------------|-----------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | | P: 4, 5, 6, 8, 9, 13 |
| Small Organ [1] | P | P | P | | P | P | P | | | P: 4, 5, 6, 8, 9,
13, 14 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | | P: 4, 5, 6, 8, 9,
12, 13 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional
(including Nerve Blocking) | P | P | P | | P | P | P | | | P: 4, 5, 6, 8, 9,
13, 14 |
| Musculo-skeletal Superficial
(including Nerve Blocking) | P | P | P | | P | P | P | | | P: 4, 5, 6, 8, 9,
13, 14 |
| Other (Urological) | | | | | | | | | | |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
(1) Small Organs includes Breast, Thyroid and Testicles [2] Cardiac is Adult and Pediatric (3) Combined modes are: B + M + PW + CW + CFM + PD (4) CMM (5) MView ાંઠા 3D [8] VPan (ગુ XView [12] Strain [13] TP Vicw (14) ElaXto
Masa S/oth
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110688
15
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, | ||
| 13 | ||||||||||
| Small Organ [1] | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, | ||
| 13, 14 | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, | ||
| 10, 12, 13 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organ |
|---|---|
| [2] | Cardiac is A |
| [3] | Combined m |
| [4] | CMM |
| [5] | MView |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [10] | QIMT |
| [12] | Strain |
| [13] | TP View |
| [14] | FlexXto |
gans includes Breast, Thyroid and Testicles
is Adult and Pediatric
ed modes are: B + M + PW + CW + CFM + PD
May S. Patel
Division Sign-On
Divis of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110688
16
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | Other (specify) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| [3] | Tissue | ||||||||||
| Velocity | |||||||||||
| Mapping | Tissue | ||||||||||
| Enhancement | |||||||||||
| Imaging (TEI) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13 | |||
| Small Organ [1] | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13, | |||
| 14 | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 10, | |||
| 12, 13, N:15 | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13, | |||
| 14 | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13, | |||
| 14 | |||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles | |
|---|---|---|
| [2] | Cardiac is Adult and Pediatric | |
| [3] | Combined modes are: B + M + PW + CFM + PD | |
| [4] | CMM | |
| [5] | MView | |
| [6] | 3D | |
| [8] | VPan | |
| [9] | XView | |
| [10] | QIMT | |
| [13] | TP View | |
| [14] | ElaXto | Office of |
| [15] | Quality Doppler Prodile (QDP) |
Mury S. Patel
(Division Sign-Off)
Division of Radiological Devices te of In Vitro Diagnostic Device Evaluation and Safety
510K K110688
17
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (3) | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 11 | ||
| Small Organ [1] | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 11 | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (2) | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | . | |||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, | ||
| 12, 13 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
(1)
(기
(3)
(4)
(S)
(છ)
(12)
| | 3|
Small Organs includes Breast, Thyroid and Testicles . Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CFM + PD смм
MView 3D
VPan
XView
Strain
TP Vicw
(8) lal
Mary Stott
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110688
18
7340 - C5-2 R13
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | Other (specify) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| [3] | Tissue | ||||||||||
| Velocity | |||||||||||
| Mapping | |||||||||||
| (TVM) | Tissue | ||||||||||
| Enhancement | |||||||||||
| Imaging (TEI) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 10 | |||
| Abdominal | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | |||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | |||
| Small Organ [1] | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | |||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 12 | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| (including Nerve Blocking) | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| (including Nerve Blocking) | |||||||||||
| Other (Urological) |
510K
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CFM + PD |
| [5] | MView |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [12] | Strain |
| Mary S Patel | |
| (Division Sign-Off) | |
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety |
Prescription Use Only Per 21 CFR 801 Part D
Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)
19
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | ||
| Small Organ [1] | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9 | ||
| Neonatal Cephalic | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | ||
| Adult Cephalic | ||||||||||
| Cardiac [2] | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 11, | ||
| 12 | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 12; N: | ||
| 15 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9 | ||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9 | ||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CFM + PD |
| [4] | CMM |
| [5] | MView |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [11] | Stress |
| [12] | Strain |
| [15] | Quality Doppler Profile (QDP) |
Mary S. Pott
(Division Sign-Off)
of Radiological Devices gnostic Device Evaluation and Safety
510K. K110688
20
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhacement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 10 | ||
| Abdominal | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | ||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | ||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 12 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) | P | P | P | P | P | P | P | P: 5, 6, 8, 9 |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles | |
|---|---|---|
| [2] | Cardiac is Adult and Pediatric | |
| [3] | Combined modes are: B + M + PW + CFM + PD | |
| [5] | MView | |
| [6] | 3D | |
| [8] | VPan | |
| [9] | XView | |
| [10] | QIMT | |
| [12] | Strain |
Mary S Pastel
(Division Sign-Off)
ogical Devices vice Evaluation and Safety
510K K110688
21
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Operations | ||||||||||
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 10 | ||
| Abdominal | P | P | P | P | P | P | P | P: 5,6,8,9 | ||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | ||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 12 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) | P | P | P | P | P | P | P | P: 5, 6, 8, 9 |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CFM + PD |
| [5] | MView |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [10] | QIMT |
| [12] | Strain |
| (Division Sign-Off) | |
| Division of Radiological Devices |
Mary S. Pottl
(Division Sign-Off)
Office of In Vitro Diagnostic Device Evaluation and Safety
K110688
510K
.
Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)
:
22
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| [3] | Tissue | ||||||||||
| Velocity | |||||||||||
| Mapping | |||||||||||
| (TVM) | Tissue | ||||||||||
| Enhancement | |||||||||||
| Imaging (TEI) | Other (specify) | ||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 10 | |||
| Abdominal | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | |||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ [1] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | ||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| (including Nerve Blocking) | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| (including Nerve Blocking) | |||||||||||
| Other (Urological) | P | P | P | P | P | P | P | P | P: 5, 6, 8, 9 |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
[1] Small Organs includes Breast, Thyroid and Testicles (2) Cardiac is Adult and Pediatric (3) Combined modes are: B + M + PW + CFM + PD (5) MView (e) 3D (8) VPan lal XView (10) QIMT (12) Strain ision Sinn. Divis of Radiological Devices Office of In Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K110688
23
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| [3] | Tissue | ||||||||||
| Velocity | |||||||||||
| Mapping | |||||||||||
| (TVM) | Tissue | ||||||||||
| Enhacement | |||||||||||
| Imaging (TEI) | Other (specify) | ||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 10 | |||
| Abdominal | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | |||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | |||
| Small Organ (1) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 12 | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | |||
| Musculo-skeletal Superficial | |||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | |||
| Other (Urological) | P | P | P | P | P | P | P | P: 5, 6, 8, 9 |
N: New indication: P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CFM + PD |
| [5] | MView |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [10] | QIMT |
| [12] | Strain |
| (Division Sign-Of | |
| Division of Radiological | |
| Office of In Vitro Diagnostic Device |
Mary S Pett
(Division Sign-Off)
Devices valuation and Safety
510K K110688
24
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows
| Clinical Application | Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| [3] | Tissue | ||||||||||
| Velocity | |||||||||||
| Mapping | |||||||||||
| (TVM) | Tissue | ||||||||||
| Enhacement | |||||||||||
| Imaging (TEI) | Other (specify) | ||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P | P | P: 5.6, 8, 9, 10 | |||
| Abdominal | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | |||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | 5, 6. 8, 9 | |||
| Small Organ [1] | P | P | P | P | P | P | P | ||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 5,6,8,9,12 | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional (including | |||||||||||
| Nerve Blocking) | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9 | |||
| Musculo-skeletal Superficial (including | |||||||||||
| Nerve Blocking) | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9 | |||
| Other (Urological) | P | P | P | P | P | P | P | P: 5, 6, 8, 9 |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
시 Small Organs includes Breast, Thyroid and Testicles 12| Cardiac is Adult and Pediatric (3) Combined modes are: B + M + PW + CFM + PD ત્ત્વન смм (5) MView (છ) 3D C [8] VPan (9) XVicw (Division Sign-Off) QIMT (10) Division of Radiological Devices [12] Strain Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110688
25
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Combined | |||||||||||
| [3] | Tissue | |||||||||||
| Velocity | ||||||||||||
| Mapping | ||||||||||||
| (TVM) | Tissue | |||||||||||
| Enhancement | ||||||||||||
| Imaging (TEI) | Other (specify) | |||||||||||
| Ophthalmic | ||||||||||||
| Fetal | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 10 | ||||
| Abdominal | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | ||||
| Intraoperative (Abdominal) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 10 | ||||
| Small Organ [1] | P: 5, 6, 8, 9 | |||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac [2] | ||||||||||||
| Transesophageal (Cardiac) | ||||||||||||
| Transesophageal (Non Cardiac) | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 10 | ||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| (including Nerve Blocking) | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| (including Nerve Blocking) | ||||||||||||
| Other (Urological) | P | P | P | P | P | P | P | P: 5, 6, 8, 9 |
Previously cleared via K091009
| |
(2)
(3)
(5)
ાંઠા
ાકો
lal
(10)
112]
Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CFM + PD MView
3D
V Pan
XVicw
QIMT
Strain
Mary S. Patel
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110688
26
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||
| · Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| [3] | Tissue | ||||||||||
| Velocity | |||||||||||
| Mapping | |||||||||||
| (TVM) | Tissue | ||||||||||
| Enhancement | |||||||||||
| Imaging (TEI) | Other (specify) | ||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 10 | |||
| Abdominal | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | |||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | |||
| Small Organ [1] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [2] | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 12 | |||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9 | |||
| Musculo-skeletal Superficial | |||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9 | |||
| Other (Urological) | P | P | P | P | P | P | P | P: 5, 6, 8, 9 |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CFM + PD |
| [4] | CMM |
| [5] | MView |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [10] | QIMT |
| [12] | Strain |
27
7340 - 2 CW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined [3] | Tissue | ||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhacement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | P | |||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E Previously cleared via K091009
| 1 | (기
Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric
Mary Spotel.
(Division Sign-Off)
Office of In valuation and Safety
510K K110688
28
7340 - 5 CW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Combined | |||||||||||
| [3] | Tissue | |||||||||||
| Velocity | ||||||||||||
| Mapping | ||||||||||||
| (TVM) | Tissue | |||||||||||
| Enhancement | ||||||||||||
| Imaging (TEI) | Other (specify) | |||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative (Abdominal) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ [1] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac [2] | ||||||||||||
| Transesophageal (Cardiac) | ||||||||||||
| Transesophageal (Non Cardiac) | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | P | |||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| (including Nerve Blocking) | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| (including Nerve Blocking) | ||||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E Previously cleared via K091009
[1] (2) Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric
Mina S. Patel
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110688
29
7340 - HF CW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhacement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K103152
(1) [2]
Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric
Muss S. Pidd
Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110688
30
7340 - E8-5 R10P
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| [3] | Tissue | ||||||||||
| Velocity | |||||||||||
| Mapping | |||||||||||
| (TVM) | Tissue | ||||||||||
| Enhacement | |||||||||||
| Imaging (TEI) | Other (specify) | ||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (Abdominal) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ [1] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac (2) | |||||||||||
| Transesophageal (Cardiac) | |||||||||||
| Transesophageal (Non Cardiac) | |||||||||||
| Transrectal | P | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | ||
| Transvaginal | P | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | ||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| (including Nerve Blocking) | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| (including Nerve Blocking) | |||||||||||
| Other (Urological) | P | P | P | P | P | P | P | P | P: 5, 6, 8, 9 |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| (1) | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| (2) | Cardiac is Adult and Pediatric |
| (3) | Combined modes are: B + M + PW + CFM + PD |
| િટો | MView |
| (e) | 3D |
| (8) | VPan |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
XVicw
- (8) lal
Mary Stodd
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaiuation and Safety
510K K110688
Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)
31
7340 - EC123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhacement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | ||
| Transvaginal | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | ||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) | P | P | P | P | P | P | P | P: 5, 6, 8, 9 |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
ן וו
(2) (3)
(5)
િશ
ાકો
lal
| Small Organs includes Breast, Thyroid and Testicles |
|---|
| Cardiac is Adult and Pediatric |
| Combined modes are: B + M + PW + CFM + PD |
| MView |
3D
VPan
XView
Mary S. Patel
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110688
32
7340 - EC1123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | P: 5, 6, 8, 9, 10 | ||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (2) | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | ||
| Transvaginal | P | P | P | P | P | P | P | P: 5, 6, 8, 9 | ||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) | P | P | P | P | P | P | P | P: 5, 6, 8, 9 |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E Previously cleared via K091009
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CFM + PD |
| [5] | MView |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [10] | QIMT |
| [14] | ElaXto |
May S. Patel
(Division Sign-Off)
adiological Devices Office of In Diagnostic Device Evaluation and Safety
510K K110688
33
7340 - BE1123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 9 | ||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 9 | ||
| Transvaginal | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 9 | ||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 9 |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CFM + PD |
| [5] | MView |
| [6] | 3D |
| [7] | 4D |
| [8] | VPan |
| [9] | XView |
Mary States
(Division Sign-Off)
Radiological Devices Divis Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110688
34
7340 - TRT33
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue Enhacement | |||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13, | ||
| 14 | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13 |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CFM + PD |
| [4] | CMM |
| [5] | MView |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [13] | TP View |
| [14] | ElaXto |
| Mary S Pastel (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K K110688 |
Prescription Use Only Per 21 CFR 801 Part D
Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)
35
7340 - TEE022
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows.
| Clinical Application | Mode of Operations | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhacement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominai | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | ||||||||||
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | P | P | P: 4, 6, 9, 11, 12 |
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [6] | 3D |
| [9] | XView |
| [11] | Stress |
| [12] | Strain |
Mury Stace
(Division Sign-Off)
Division of Radiological Devices Division of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K110688
36
7340 - TEE122
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (2) | ||||||||||
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | P | P | P: 4, 6, 9, 11, 12 |
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [6] | 3D |
| [9] | XView |
| [11] | Stress |
| [12] | Strain |
Mury Stahl
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110688
37
7340 - TEE132
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhacement | ||||||||||
| Imaging (TEI) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | ||||||||||
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | P | P | P: 4, 6, 9, 11, 12 |
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [9] | XView |
| [11] | Stress |
| [12] | Strain |
Mary S. Patel
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K 110688
38
7340 - IOE323
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical Application | Mode of Operations | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| [3] | Tissue | ||||||||
| Velocity | |||||||||
| Mapping | |||||||||
| (TVM) | Tissue | ||||||||
| Enhancement | |||||||||
| Imaging (TEI) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13 | |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13 | |
| Intraoperative Neurological | |||||||||
| Pediatric | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13 | |
| Small Organ [1] | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13 | |
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac (2) | |||||||||
| Transesophageal (Cardiac) | |||||||||
| Transesophageal (Non Cardiac) | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 12, | |
| 13 | |||||||||
| Laparoscopic | |||||||||
| Musculo-skeletal Conventional | |||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13 | |
| Musculo-skeletal Superficial | |||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13 | |
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CFM + PD |
| [4] | CMM |
| [5] | MView |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [12] | Strain |
| [13] | TP View |
Mary Slatel
(Division Sign-Off)
Radiological Devices tic Device Evaluation and Safety
510K K110688
,
39
7340 - LP323
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows
| Clinical Application | Mode of Operations | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13 | ||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | P | P | P | P | P | P | P | P: 4, 5, 6, 8, 9, 13 | ||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CFM + PD |
| [4] | CMM |
| [5] | MView |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [13] | TP View |
Device Evaluation and Safety
510K K110688
- Prescription Use Only Per 21 CFR 801 Part D
Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)
40
7340 - BS230
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhacement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | P | P | P | P | P | P | P | P | P | P: 4, 6, 7, 8, 9, 11, |
| 12 | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [6] | 3D |
| [7] | 4D |
| [8] | VPan |
| [9] | XView |
| [11] | Stress |
| [12] | Strain |
Mary Slatl
(Division Sign-Off)
insion of Rediological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110688
41
7340 - BC431
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 9, | ||
| 10 | ||||||||||
| Abdominal | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 9 | ||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 9, 12 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | ||||||||||
| Other (Urological) |
N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
Previously cleared via K091009
| [1] | Small Organs includes Breast, Thyroid and Testicle |
|---|---|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CFM + PD |
| [5] | MView |
| [6] | 3D |
| [7] | 4D |
| [8] | VPan |
| [9] | XView |
| [12] | Strain |
Mary Postle
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K R110688
Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)
42
7340 - BL433
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| [3] | Tissue | |||||||||
| Velocity | ||||||||||
| Mapping | ||||||||||
| (TVM) | Tissue | |||||||||
| Enhancement | ||||||||||
| Imaging (TEI) | Other (specify) | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Abdominal) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P | P: 4, 5, 6, 7, 8, 9, | ||
| 13 | ||||||||||
| Small Organ [1] | P | P | P | P | P | P | P | P: 4, 5, 6, 7, 8, 9, | ||
| 13 | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [2] | ||||||||||
| Transesophageal (Cardiac) | ||||||||||
| Transesophageal (Non Cardiac) | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P: 4, 5, 6, 7, 8, 9, | ||
| 13 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P: 4, 5, 6, 7, 8, 9, | ||
| 13 | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| (including Nerve Blocking) | P | P | P | P | P | P | P | P: 4, 5, 6, 7, 8, 9, | ||
| 13 | ||||||||||
| Other (Urological) |
Previously cleared via K091009
(1) Small Organs includes Breast, Thyroid and Testicles (2) Cardiac is Adult and Pediatric (3) Combined modes are: B + M + PW + CFM + PD (4) СММ ાંડા MView ાંઠા 3D (7) 4D (8) VPan ત્ત્વે XView (13) TP View
Mary S Patel
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Satet;
510K. K110688