(42 days)
No
The document does not mention AI, ML, or any related terms, and the description focuses on standard ultrasound technology and image processing.
No
The "Intended Use / Indications for Use" section states that the device is "indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis," which means it's a diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "image information for diagnosis," and the "Device Description" also labels it as "mobile diagnostic ultrasound systems."
No
The device description explicitly states it is a "mobile diagnostic ultrasound system" and mentions employing "a wide array of probes," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text clearly states that this is a "Diagnostic Ultrasound System." Ultrasound is an imaging modality that uses sound waves to create images of structures within the body, not on samples taken from the body.
- Intended Use: The intended use describes the visualization of structures and dynamic processes within the human body using ultrasound. This is consistent with in-vivo imaging, not in-vitro testing.
Therefore, based on the provided information, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Diagnostic Ultrasound System Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 And Aplio 300 Model TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the followinq clinical applications: fetal, abdominal, intraoperative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculo-skeletal (both conventional and superficial).
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
The Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 and Aplio 300 Model TUS-A300 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
fetal, abdominal, intraoperative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculo-skeletal (both conventional and superficial)
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)
Risk Analysis, Verification/Validation testing conducted through bench testing which are included in this submission demonstrates that the requirements for the improved/added features have been met. Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission. Additionally, testing of the modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
FEB 6 2013
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000
510(k) SUMMARY
-
- SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
- ADDRESS: 2. 2441 Michelle Drive Tustin, CA. 92780-2068
- ESTABLISHMENT REGISTRATION: 3. 2020563
- CONTACT PERSON: 4. Charlemagne Chua Manager, Regulatory Affairs (714) 669-7896
Date Prepared: ട. December 21, 2012
TRADE NAME(S): 6.
Diagnostic Ultrasound System Aplio 500 Model TUS-A500 V3.0 Aplio 400 Model TUS-A400 V3.0 Aplio 300 Model TUS-A300 V3.0
-
- COMMON NAME: System, Diagnostic Ultrasound
DEVICE CLASSIFICATION: 8.
Class II
Ultrasonic Pulsed Doppler Imaging System – Product Code: 90-IYN [per 21 CFR 892.1550] Ultrasonic Pulsed Echo Imaqinq System – Product Code: 90-IYO [per 21 CFR 892.1560] Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [per 21 CFR 892.1570]
9. PREDICATE DEVICE:
| Product | Marketed by | 510(k) Number | Clearance Date |
|---|---|---|---|
| Aplio 500/400/300 Diagnostic | |||
| Ultrasound System | Toshiba America | ||
| Medical Systems | K121422 | August 16, 2012 |
1
10. REASON FOR SUBMISSION:
Modification of a cleared device
11. DEVICE DESCRIPTION:
The Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 and Aplio 300 Model TUS-A300 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.
12. SUMMARY OF INTENDED USES:
The Diagnostic Ultrasound System Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 And Aplio 300 Model TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the followinq clinical applications: fetal, abdominal, intraoperative (abdominal), pediatric, small organs, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculo-skeletal (both conventional and superficial).
13. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the Aplio 500/400/300 Diaqnostic Ultrasound System, K121422, marketed by Toshiba America Medical Systems. The Aplio 500 Model TUS-A500 Version 3.0, Aplio 400 Model TUS-A400 Version 3.0 and Aplio 300 Model TUS-A300 Version 3.0, functions in a manner similar to and is intended for the same use as the predicate device. The subject device includes modifications to the cleared device which improves upon existing features such as imaging and report/communication transfer. Additionally, two new transducers, a new 4D optional feature, Luminance, and new hardware items intended to improve ease of use, are now available with the subject device.
A comparison table is included in this submission detailing the similarities and differences between the predicate device and the subject device.
14. SAFETY:
.
The device is designed and manufactured under the Quality System Requlations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, IEC 62304, NEMA UD3 Output Display and ISO 10993-1 standards.
15. TESTING
Risk Analysis, Verification/Validation testing conducted through bench testing which are included in this submission demonstrates that the requirements for the improved/added features have been met.
Software Documentation for a Moderate Level of Concern, per the FDA guidance
2
document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.
Additionally, testing of the modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices.
16. CONCLUSION
The modifications incorporated into the Aplio 500 Model TUS-A500 Version 3.0, Aplio 400 Model TUS-A400 Version 3.0 and Aplio 300 Model TUS-A300 Version 3.0 do not chanqe the indications for use or the intended use of the device. Based upon bench testing, successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 6, 2013
Toshiba America Medical Systems, Inc. c/o Mr. Charlemagne Chua Manager, Regulatory Affairs 2441 Michelle Drive TUSTIN CA 92780-2068
Re: K123992
Trade/Device Name: Aplio™ 500/400/300 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 21, 2012 Received: December 26, 2012
Dear Mr. Chua:
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 Aplio" 500/400/300 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| PST-25BT | PVT-661VT | PVT-745BTV | PLT-1005BT |
|---|---|---|---|
| PST-30BT | PVT-781VT | PVT-770RT | PLT-1202S |
| PST-50BT | PVT-674BT | PLT-604AT | PLT-1204BT |
| PST-65AT | PVT-675MV | PLT-704AT | PLT-1204BX |
| PVT-375BT | PVT-681MV | PLT-704SBT | PLT-1204MV |
| PVT-375MV | PVT-712BT | PLT-705BTF | PET-508MA |
| PVT-382BT | PVT-745BTF | PVT-705BTH | PET-510MB |
| PVT-382MV | PVT-745BTH | PLT-805AT | PET-512MC |
4
PC-20M PC-50M
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please 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.
Sean M. Boyd -S for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure(s)
5
Indications for Use
510(k) Number (if known):
Device Name:
Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
Indications for Use:
The Diagnostic Ultrasound System Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 And Aplio 300 Model TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diaqnosis in the followinq clinical applications: fetal, abdominal, intraoperative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculo-skeletal (both conventional and superficial).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Sean M. Boyd -S
Page 1 of _ 1
(Division Sign C
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
510(k) k03992
6
System: _Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer: _
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical
Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other [Note] |
|---------------------------------------------------|---|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|----------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | | P | 5,7,8,9,10,14 |
| Abdominal | P | P | P | P | P | 2,3 | P | P | P | | P | 5,7,8,9,10,11,12,14 |
| Intra-operative
(Abdominal) | P | P | P | | P | 2 | P | P | P | | | 4,5,7,11 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2,3 | P | P | P | | P | 5,7,8,9,10,12,14 |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14 |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Trans-rectal | P | P | P | | P | 2 | P | P | P | | P | 4,5,7,11,12 |
| Trans-vaginal | P | P | P | | P | 2 | P | P | P | | P | 4,5,7,11,12 |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph.
(non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | P | P | P | | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14 |
| Musculo-skeletal
(Superficial) | P | P | P | | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | | | | | 4,13 |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Previous 510(k) of the transducers: K121422 and K103629
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 8 STIC
Note 6 MicroPure
Note 10 STIC Color Note 11 Elastography
Note 12 Fusion Note 13 2D WMT Note 14 Boost
Note 7 Precision Imaging
Note 9 3D Color (Volume Color)
Note 5 ApliPure
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics
510(k) K123992
Sean M. Boyd -S
7
System: _ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer:__ PST-25BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | 11 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Prescription Use Only (Per 21 CFR 801.109)
Note 13 2D WMT
Note 14 Boost
Sean M. Boyd -S
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostic
510(k) C1239942
Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion
8
System: __ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer: PST-30BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | 11 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion
Note 13 2D WMT Note 14 Boost
(Division Sign Off) Division of Radiological Health
Prescription Use Only (Per 21 CFR 801.109)
Office of In Vitro
. Boyd -S
Sean N
510(k) K123992
9
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer:_ PST-50BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
(Note) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | 11 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI Note 5 ApliPure
Note 6 MicroPure
Note 7 Precision Imaging
Note 8 STIC
Note 9 3D Color (Volume Color)
Note 10 STIC Color
Note 11 Elastography Note 12 Fusion Note 13 2D WMT
Note 14 Boost
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics and
510(k) K123992
10
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer:__ PST-65AT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | 11 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost
(Division Sign Off) Division of Radiological ിന്നാം of In Vitro Diagno 510/k)
11
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: __ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer:_ PVT-375BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | 5, 7 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5, 7, 11, 12 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | 5, 7, 12 |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
510/k
- Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost
Sean M. Boyd -S.
Prescription Use Only (Per 21 CFR 801.109)
(Division Sign Off)
Division of Radiological He Office of In
12
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: __ Aplio 500, Aplio 400, Aplio 300 V3.0 PVT-375MV Transducer:_
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | N | 5,7,8,9,10 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | N | 5,7,8,9,10 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | N | 5,7,8,9,10 |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost
Prescription Use Only (Per 21 CFR 801.109)
Sean M. Boyd -S
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Di
510(k) K123992
13
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: _ Aplio 500, Aplio 400, Aplio 300 V3,0 Transducer: PVT-382BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | 5,7 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,7,12 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | 5,7,12 |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost
Prescription Use Only (Per 21 CFR 801.109)
Sean M. Boyd -S
(Division Signoff)
Division of Radiological Health
Office of In Vitro
510(k) 12392
14
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: _Aplio 500, Aplio 400, Aplio 300 V3.0 PVT-382MV Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | P | 5,7,9 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | P | 5,7,9 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | P | 5,7,9 |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost
(Division Sign of) Sean M. Boyd -S
Prescription Use Only (Per 21 CFR 801.109)
Office of In Vitro Diagnostics and Radiologi
Division of Radiological Health
510(k) K123992
15
and the same of the same of the same of the same of the states of the states and
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
Aplio 500, Aplio 400, Aplio 300 V3.0 System: __ Transducer:___PVT-661VT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | P | P | P | P | P | 2 | P | P | P | | | 4,5,7,11 |
| Trans-vaginal | P | P | P | P | P | 2 | P | P | P | | | 4,5,7,11 |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle.
Prescription Use Only (Per 21 CFR 801.109)
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes BM: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI Note 5 ApliPure Note 6 MicroPure
Note 7 Precision Imaging
Note 8 STIC
Note 9 3D Color (Volume Color)
Note 10 STIC Color Note 11 Elastography
Note 12 Fusion
Note 13 2D WMT
Note 14 Boost
Sean M. Boyd -S
(Division Sign Off)
Division of Radiological Heal
Office of In Vit
510(k) K123992
16
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer ... PVT-781VT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) | THI | Dynamic | ||||||||||
| Flow | Power | CHI | ||||||||||
| 2D | 4D | Other | ||||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | E | E | E | E | E | 2 | E | E | E | 4,5,7,11,12 | ||
| Trans-vaginal | E | E | E | E | E | 2 | E | E | E | 4,5,7,11,12 | ||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal | ||||||||||||
| (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: N/A (This transducer is being added under this submission)
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 MicroPure
- Note 7 Precision Imaging Note 8 STIC
- Note 9 3D Color (Volume Color)
- Note 10 STIC Color
- Note 11 Elastography Note 12 Fusion
Note 13 2D WMT
- Note 14 Boost
Prescription Use Only (Per 21 CFR 801.109)
Sean M. Boyd -S
Division of Radiological H
Office of In Viti Diagnostics and Radiologic
510(k) K123992
17
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: _ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer:__ PVT-674BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | | | 5,7,14 |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | | 5,7,14 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | P | | | 5,7,14 |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost
Prescription Use Only (Per 21 CFR 801.109)
Sean M. Boyd -S
(Division Sign Off)
Division of Radiological Office of In Vitro I
18
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: __ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer: PVT-675MV
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes BM: B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost
(Division Org. Pt. 2)
Office of In Vitro Diagnostics and Radiological Health
510(k) K123992
19
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: _ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer: __ PVT-681MV
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
(Note) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | P | P | P | P | P | 2 | P | P | P | P | P | 4,5,7,9,1 |
| Trans-vaginal | P | P | P | P | P | 2 | P | P | P | P | P | 4,5,7,9,1 |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography Note 12 Fusion (Division Sign Off) Note 13 2D WMT Note 14 Boost Division of Rac
Prescription Use Only (Per 21 CFR 801.109)
Office of In \
510(k) K123942
20
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: __ Aplio 500, Aplio_400, Aplio 300 V3.0 Transducer:___PVT-712BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | P | 5,7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | P | | | 5,7 |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 2 | P | P | P | | | 5,7 |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid. breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color (Division Sign Off) Note 11 Elastography Note 12 Fusion Division of Radiological Health Note 13 2D WMT Note 14 Boost Office of In Vitro Dia
Office of In Vitro Diagnostics and Radiological Health
Sean M. Bove
510(k) K123192
21
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: Aplio 300, Aplio 400, Aplio 500 v3.0 PVT-745BTF Transducer:_
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,7 |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | P | | | 5,7 |
| Intra-operative (Neuro) | | | | | | 1 | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) (Division Sign Off) Note 10 STIC Color Division of Radiological Health Note 11 Elastography Note 12 Fusion Office of In Vitro Diagnostics and Radiological Note 13 2D WMT Note 14 Boost
K123992 Sean M. Boyd -S
22
System: _ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer:_ PVT-745BTH
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | |||||||||||
| (Specify) | THI | Dynamic | ||||||||||
| Flow | Power | CHI | ||||||||||
| 2D | 4D | Other | ||||||||||
| [Note] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | P | P | P | P | P | 2 | P | P | P | 5,7 | ||
| Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | 5,7 | ||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal | ||||||||||||
| (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography (Division Sign Off) Note 12 Fusion Note 13 2D WMT Division of Radiglogical H Note 14 Boost
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
Sean M. Boyd - S
510(k) K123942
23
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: __ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer:__ PVT-745BTV
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
|------------------------------------------------|---|---|-----|-----|------------------|-----------------------|-----|-----------------|-------|-----------|----|-----------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | | 5,7 |
| Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | | | 5,7 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC (Division Sign Off) Note 9 3D Color (Volume Color) Note 10 STIC Color Division of Radiological Health Note 11 Elastography Note 12 Fusion Office of In Vitro Diagnostics and Radiological Health Note 13 2D WMT Note 14 Boost
510(K
24
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: __ Aplio 500, Aplio 400, Aplio 300 V3,0 Transducer:_ PVT-770RT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD CWD | Color | ||||||||
| Doppler | Combined THI | |||||||||||
| (Specify) |
- | | Dynamic
Flow | Power | CHI
20 | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | P | P | P | | P | 2 | P | P | P | | | 4,5,7,11 |
| Trans-vaginal | P | b | P | | P | 2 | P | P | b | | | 4,5,7,11 |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging
Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color
Note 11 Elastography
Note 12 Fusion Note 13 2D WMT
Note 14 Boost
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radlological Hea
Prescription Use Only (Per 21 CFR 801.109)
510(k)
25
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: __ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer:_ PLT-604AT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | P | P | 2 | P | P | P | | | 5,7 | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | P | P | P | P | P | 2 | P | P | P | | | 5,7 | |
| Musculo-skeletal (Superficial) | P | P | P | P | P | 2 | P | P | P | | | 5,7 | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | 2 | P | P | P | | | 5,7 | |
| Other (Specify) | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes BM; BPWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (Division Sign Off) Note 8 STIC Note 9 3D Color (Volume Color) Division of Radiological Health Note 10 STIC Color Note 11 Elastography Office of In Vitro Diagnostics and Radiological Health Note 12 Fusion Note 13 2D WMT Note 14 Boost
510(k) K123492 Sean M. Boyd -S
26
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: _ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer:_ PLT-704AT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | 5,7 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | P | P | P | | P | 2 | P | P | P | | | 5,7 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | 5,7 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | P | | | 5,7 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) (Division Sign Off) Note 10 STIC Color Note 11 Elastography Division of Radiological Health Note 12 Fusion Office of In Vitro Diagnostics and Flaction of Hackorogical Health
Office of In Vitro Diagnostics and Flaction of Health
Note 13 2D WMT Note 14 Boost
ites and Radiological Hea
(K) K123442 Sean M. Boyd -S
27
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: _ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer:___PLT-704SBT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD CWD | Color | ||||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 40 | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | 5,7,14 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | P | P | P | | P | 2 | P | P | P | | | 5,7,14 |
| Musculo-skeletal (Superficial) | b | P | P | | P | 2 | P | P | P | | | 5,7,14 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | P | | | 5,7,14 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) (Division Sign Off) Note 10 STIC Color Division of Radiological Health Note 11 Elastography Office of In Vitro Diagnostics are Note 12 Fusion Note 13 2D WMT Note 14 Boost Prescription Use Only (Per 21 CFR 801.109)
28
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: __ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer:____PLT-705BTF
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||
| (Tracks 3) | B | M | PWD CWD | Color | |||||||
| Doppler | Combined | ||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | P | 2 | P | P | P | | | 5,7 |
| Intra-operative (Abdominal) | P | P | P | P | 2 | P | P | P | | | 5,7 |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/MD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC (Division Sign Off) Note 9 3D Color (Volume Color) Note 10 STIC Color Division of Radiological Health Note 11 Elastography Note 12 Fusion Office of In Vitro Diagnostics and Radiological Health Note 13 2D WMT Note 14 Boost
510(k) 423992 Sean M. Boyd -S
29
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: _ Aplio 500, Aplio 400, Aplio 300 V3.0 PVT-705BTH Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | | 5,7 | |
| Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | | | 5,7 | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure (Division Sign Off) Note 6 MicroPure Note 7 Precision Imaging Division of Radiological Health Note 8 STIC Note 9 3D Color (Volume Color) Office of In Vitro Diagnostics and Radiological Health Note 10 STIC Color Note 11 Elastography 123492 Note 12 Fusion 510K Note 13 2D WMT Note 14 Boost
Prescription Use Only (Per 21 CFR 801.109)
Sean M. Boyd -S
30
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: _Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer: PLT-805AT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | P | P | 2 | P | P | P | | | | 5,6,7,11 |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | P | P | 2 | P | P | P | | | | 5,6,7,11 |
| Musculo-skeletal (Superficial) | P | P | P | P | P | 2 | P | P | P | | | | 5,6,7,11 |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | 2 | P | P | P | | | | 5,6,7,11 |
| Other (Specify) | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) Note 10 STIC Color
Note 11 Elastography
Note 12 Fusion Note 13 2D WMT Note 14 Boost
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
510(k) _M23992
Sean M. Boyd -S
31
System: _Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer: PLT-1005BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||
| (Tracks 3) | B | M PWD CWD | Color | ||||||||
| Doppler | Combined | ||||||||||
| (Specify) | THI | Dynamic | |||||||||
| Flow | Power | CHI | |||||||||
| 2D | 4D | Other | |||||||||
| (Notel | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-operative (Abdominal) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify) (1) | E | E | E | E | 2 | E | E | E | 5,6,7,11,14 | ||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | E | E | E | E | 2 | E | E | E | 5,6,7,11,14 | ||
| Musculo-skeletal (Superficial) | E | E | E | E | 2 | E | E | E | 5,6,7,11,14 | ||
| Intravascular | |||||||||||
| Other (Specify) | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Intravascular (Cardiac) | |||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Other (Specify) | |||||||||||
| Peripheral vessel | E | ਦਿ | E | ਦ | 2 | E | E | E | 5,6,7,11,14 | ||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: N/A (This transducer is being added under this submisston)
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes BM: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
2100
- Note 4 TDI
- Note 5 ApliPure
Note 6 MicroPure
-
Note 7 Precision Imaging
Note 8 STIC -
Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography
Note 12 Fusion Note 13 2D WMT
Note 14 Boost
(Division Sign Off)
Division of Radiological Heatth
Office of In Vitro Diagnostics and Radiological Health
Sean M. Boyd -S
32
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer:____ PLT-1202S
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
(Note) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | | P | | | 4,5,11 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | | P | | | 4,5,11 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | | P | | | 4,5,11 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | | P | | | 4,5,11 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | N | N | N | | N | 2 | N | | N | | | 4,5,11 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 . Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI Note 5 ApliPure
Note 6 MicroPure
Note 7 Precision Imaging
Note 8 STIC
Note 9 3D Color (Volume Color)
Note 10 STIC Color Note 11 Elastography
Note 12 Fusion
Note 13 2D WMT Note 14 Boost
(Division Sign Off)
Division of Radiological Health
Office of in Vitro Diagnostics and
Mental Health
510(k) 123492 - Sean M. Boyd -S
33
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: __ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer: PLT-1204BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,1 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,1 |
| Musculo-skeletal (Superficial) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,1 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | N | N | N | N | N | 2 | N | N | N | | | 4,5,6,7,1 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC (Division Sign Off) Note 9 3D Color (Volume Color) Note 10 STIC Calor Division of Radiological Health Note 11 Elastography Note 12 Fusion Office of In Vitro Diagnostics and Radiological Health Note 13 2D WMT Note 14 Boost
510(k) K123992-Sean M. Boyd - S
34
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: Aplio 500 V3.0 Transducer: PLT-1204BX
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) | THI | Dynamic | |||||||||||
| Flow | Power | CHI | |||||||||||
| 2D | 4D | Other | |||||||||||
| [Note] | |||||||||||||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intra-operative (Abdominal) | |||||||||||||
| Intra-operative (Neuro) | |||||||||||||
| Laparoscopic | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Specify) (1) | P | P | P | P | 2 | P | P | P | 5,7 | ||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Trans-rectal | |||||||||||||
| Trans-vaginal | |||||||||||||
| Trans-urethral | |||||||||||||
| Trans-esoph. (non-Card.) | |||||||||||||
| Musculo-skeletal | |||||||||||||
| (Conventional) | P | P | P | P | 2 | P | P | P | 5,7 | ||||
| Musculo-skeletal (Superficial) | P | P | P | P | 2 | P | P | P | 5,7 | ||||
| Intravascular | |||||||||||||
| Other (Specify) | |||||||||||||
| Cardiac Adult | |||||||||||||
| Cardiac Pediatric | |||||||||||||
| Intravascular (Cardiac) | |||||||||||||
| Trans-esoph. (Cardiac) | |||||||||||||
| Intra-cardiac | |||||||||||||
| Other (Specify) | |||||||||||||
| Peripheral vessel | P | P | P | P | 2 | P | P | P | 5,7 | ||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging Note 8 STIC Note 9 3D Color (Volume Color) (Division Sign Off) Note 10 STIC Color Note 11 Elastography Division of Radiological Health Note 12 Fusion Note 13 2D WMT Office of in Vitro Diagnostics and Note 14 Boost
Office or In Vitro Diagnostics and Radiological Health
510(k) C123992 Sean M. Boyd -
35
System: __ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer:_ PLT-1204MV
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||
| (Tracks 3) | B | M | PWD CWD | Color | |||||||
| Doppler | Combined | ||||||||||
| (Specify) | THI | Dynamic | |||||||||
| Flow | Power | CHI | |||||||||
| 2D | 4D | Other | |||||||||
| [Note] | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-operative (Abdominal) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify) (1) | P | P | P | P | 2 | P | P | P | P | 5,7,8,9,10 | |
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | P | P | P | P | 2 | P | P | P | P | 5,7,8,9,10 | |
| Musculo-skeletal (Superficial) | P | P | P | P | 2 | P | P | P | P | 5,7,8,9,10 | |
| Intravascular | |||||||||||
| Other (Specify) | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Intravascular (Cardiac) | |||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Other (Specify) | |||||||||||
| Peripheral vessel | P | P | P | P | 2 | P | P | P | P | 5,7,8,9,10 | |
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (Division Sign Off) Note 8 STIC Note 9 3D Color (Volume Color) Division of Radiotogical Health Note 10 STIC Color Note 11 Elastography Office of In Vitro Diagnostics and Radiological Health Note 12 Fusion Note 13 2D WMT Note 14 Boost
510(k) 1223992 Sean M. Boyd -S
36
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: _ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer:_ PET-508MA
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) * | THI | Dynamic | |||||||||||
| Flow | Power | CHI | |||||||||||
| 2D | 4D | Other | |||||||||||
| [Note] | |||||||||||||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intra-operative (Abdominal) | |||||||||||||
| Intra-operative (Neuro) | |||||||||||||
| Laparoscopic | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Specify) (1) | |||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Trans-rectal | |||||||||||||
| Trans-vaginal | |||||||||||||
| Trans-urethral | |||||||||||||
| Trans-esoph. (non-Card.) | |||||||||||||
| Musculo-skeletal | |||||||||||||
| (Conventional) | |||||||||||||
| Musculo-skeletal (Superficial) | |||||||||||||
| Intravascular | |||||||||||||
| Other (Specify) | |||||||||||||
| Cardiac Adult | |||||||||||||
| Cardiac Pediatric | |||||||||||||
| Intravascular (Cardiac) | |||||||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | 4,13 | |||||
| Intra-cardiac | |||||||||||||
| Other (Specify) | |||||||||||||
| Peripheral vessel | |||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes BM; BPWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure (Division Sign Off) Note 7 Precision Imaging Note 8 STIC Division of Radiological Health Note 9 3D Color (Volume Color) Office of In Vitro Diagnostics and Radiological Health Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT 510(K Note 14 Boost
Sean M. Boyd -S
37
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer:_ PET-510MB
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) | THI | Dynamic | ||||||||||
| Flow | Power | CHI | ||||||||||
| 2D | 4D | Other [Note] | ||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal | ||||||||||||
| (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | 4,13 | ||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure (Division Sign Off) Note 7 Precision Imaging Division of Radiological Health Note 8 STIC Note 9 3D Color (Volume Color) Office of In Vitro Diagnostics and Radiological Health Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT Note 14 Boost
Prescription Use Only (Per 21 CFR 801.109)
Sean M. Bovd -S
38
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: _ Aplio 500, Aplio 400, Aplio 300 V3.0 Transducer: PET-512MC
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) | THI | Dynamic | |||||||||||
| Flow | Power | CHI | |||||||||||
| 2D | 4D | Other | |||||||||||
| [Note] | |||||||||||||
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intra-operative (Abdominal) | |||||||||||||
| Intra-operative (Neuro) | |||||||||||||
| Laparoscopic | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Specify) (1) | |||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Trans-rectal | |||||||||||||
| Trans-vaginal | |||||||||||||
| Trans-urethral | |||||||||||||
| Trans-esoph. (non-Card.) | |||||||||||||
| Musculo-skeletal | |||||||||||||
| (Conventional) | |||||||||||||
| Musculo-skeletal (Superficial) | |||||||||||||
| Intravascular | |||||||||||||
| Other (Specify) | |||||||||||||
| Cardiac Adult | |||||||||||||
| Cardiac Pediatric | |||||||||||||
| Intravascular (Cardiac) | |||||||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | 4,13 | |||||
| Intra-cardiac | |||||||||||||
| Other (Specify) | |||||||||||||
| Peripheral vessel | |||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K103629
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes BM; BPWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure Note 7 Precision Imaging (Division Sign Off) Note 8 STIC Note 9 3D Color (Volume Color) Division of Radiological Health Note 10 STIC Color Note 11 Elastography Office of In Vitro Diagnostics and Radiological Health Note 12 Fusion Note 13 2D WMT Note 14 Boost 5100
(k) H. 2392 Sean M. Boyd -S
39
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: _ Aplio 500, Aplio 400, Aplio 300 V3,0 Transducer:_ PC-20M
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
|------------------------------------------------|---|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | P | | | | | | | | | |
| Cardiac Pediatric | | | P | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | P | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 5 ApliPure Note 6 MicroPure (Division Sign Off) Note 7 Precision Imaging Note 8 STIC Division of Radiological Health Note 9 3D Color (Volume Color) Office of In Vitro Diagnostics and Radiological Health Note 10 STIC Color Note 11 Elastography Note 12 Fusion Note 13 2D WMT 510(K Note 14 Boost
Prescription Use Only (Per 21 CFR 801.109)
Sean M. Boyd -S
40
510(k) Premarket Notification Aplio 500/400/300 V3.0 Diagnostic Ultrasound System
System: _ Aplio 500, Aplio 400, Aplio 300 V3.0 FC-50M Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify)* | THI | Dynamic | ||||||||||
| Flow | Power | CHI | ||||||||||
| 2D | 4D | Other | ||||||||||
| (Note) | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal | ||||||||||||
| (Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | P | |||||||||||
| Cardiac Pediatric | P | |||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | P | |||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121422
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 MicroPure
Note 7 Precision Imaging
Note 8 STIC
Note 9 3D Color (Volume Color) Note 10 STIC Color Note 11 Elastography
Note 12 Fusion
Note 13 2D WMT Note 14 Boost
510(k) 423992 Sean M. Boyd - S
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health