(15 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like training sets, test sets, or performance metrics typically associated with AI/ML devices.
No
The "Intended Use / Indications for Use" section clearly states "Diagnostic ultrasound imaging or fluid flow analysis", indicating its primary function is diagnostic, not therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." This directly indicates its role in diagnosis.
No
The device description explicitly states it employs a wide range 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. They are used to examine these samples outside of the body.
- Device Description: The description clearly states this is a "Diagnostic ultrasound imaging or fluid flow analysis of the human body". Ultrasound is a non-invasive imaging technique that uses sound waves to create images of internal body structures within the body.
- Intended Use: The intended use is for imaging and fluid flow analysis of the human body, not for testing samples taken from the body.
Therefore, based on the provided information, this device is a diagnostic imaging system, specifically an ultrasound system, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended to be used for the following type of studies; cardiac, transesophageal, abdominal and peripheral vascular.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
For the system with all transducers:
Small Organ, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel.
Abdominal (New Indication)
Cardiac Adult (New Indication)
Cardiac Pediatric (New Indication)
For transducer PST-25SX:
Cardiac Adult, Cardiac Pediatric
For transducer PST-30BT:
Abdominal (New Indication)
Cardiac Adult (New Indication)
Cardiac Pediatric (New Indication)
For transducer PST-30SBT:
Cardiac Adult, Cardiac Pediatric
For transducer PST-50BT:
Cardiac Adult (New Indication)
Cardiac Pediatric (New Indication)
For transducer PST-65AT:
Cardiac Adult (New Indication)
Cardiac Pediatric (New Indication)
For transducer PLT-704SBT:
Small Organ, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Peripheral vessel.
For transducer PET-511BTM:
Trans-esoph. (Cardiac)
For transducer PC-20M:
Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
This device is a mobile system is a Track 3 device that employs a wide range of probes that include flat linear array and sector array with a frequency range of approximately 2.5 MHz to 7.5 MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic pulsed doppler imaging, Ultrasonic pulsed echo imaging
Anatomical Site
Cardiac, transesophageal, abdominal, peripheral vascular, Small Organ, Musculo-skeletal (Conventional), Musculo-skeletal (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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
FEB - 62009
Toshiba America Medical Systems, Inc.
510(k) Premarke: Notification Aplio™ Artida (v2.0) SSH-880CV Ultrasound System
510(k) Summary
Submitter's Name: Toshiba America Medical Systems, Inc. Address: PO Box 2068, 2441 Michelle Drive, Tustin, CA 92781-2068 Contact: Paul Biggins, Director of Regulatory Affairs Telephone No .: (714) 730-5000
Device Proprietary Name: Aplio Artida v2.0 SSH-880CV Common Name: Diagnostic Ultrasound System
Classification:
- Regulatory Class: II A
- Review Category: Tier II
- . Ultrasonic Pulsed Doppler Imaging System - Product Code: 90-IYN [Federal Reg. No .: 892.1550]
- Ultrasonic Pulsed Echo Imaging System Product Code: 90-IYO . [Federal Reg. No .: 892.1560]
- Diagnostic Ultrasonic Transducer Product Code: 90-ITX . [Federal Reg. No .: 892.1570]
Identification of Predicate Devices:
Toshiba America Medical Systems believes that this device is substantially equivalent to:
- Toshiba Ultrasound Diagnostic System Aplio Artida v2.0 SSH-880CV; 510(k) K080160. ◆
- . Toshiba Ultrasound Diagnostic System Aplio XG SSA-790A V3.0; 510(k) K082119.
Device Description:
This device is a mobile system is a Track 3 device that employs a wide range of probes that include flat linear array and sector array with a frequency range of approximately 2.5 MHz to 7.5 MHz.
Indication of Use:
This device is intended to be used for the following type of studies; cardiac, transesophageal, abdominal and peripheral vascular.
Declaration of Conformity:
This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-1 (applicable portions), IEC 60601-1-2 (applicable portion), IEC 60601-1-4 (applicable portions), IEC60601-2-37 (applicable portions), and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.
1
Image /page/1/Picture/0 description: The image shows the text "510(k) Premarket Notification". The text is in a simple, sans-serif font. Above the text is a dark, irregular shape that appears to be an obscured image or logo.
Aplio™ Artida (v2.0) SSH-880CV Ultrasound System
' Standards Form:
(
Please see the attached standard form of the IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4 and IEC 60601-2-37.
Reason for Submission:
There is no new clinical application. The indication of use "abdominal" is added to the Indication of Use.
Submission Type:
This device is a Track 3 device. The submission type is Track 3.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K090158
Trade/Device Name: Aplio Artida v2.0 SSH-880CV Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 21, 2009 Received: January 22, 2009
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
EB - 6 2009
This determination of substantial equivalence applies to the following transducers intended for use with the Aplio Artida v2.0 SSH-880CV, as described in your premarket notification:
Transducer Model Number
PST-25SX PST-30BT PST-30SBT PST-50BT PST-65AT PLT-704SBT
3
PET-511BTM PC-20M
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact John Chen at (240) 276-3666.
Sincerely yours,
Helene Leun
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
4
510(k) Premarket Notification Aplio™ Artida (v2.0) SSH-880CV Ultrasound System
Diagnostic Ultrasound Indications For Use Form
System: __Aplio Artida v2.0 SSH-880CV 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 | TDI | CHI
2D | 4D
(Realtime
3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | N | N | N | N | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | P | P | P | P | P | P | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | P | P | P | | P | P | P | P | P | | | |
| Musculo-skeletal (Superficial) | P | P | P | | P | P | P | P | P | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | P | P | N | N | P | P | P |
| Cardiac Pediatric | P | P | P | P | P | P | P | N | N | P | P | P |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | | | P | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | P | P | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Previous 510(k) of the transducer: K080160
Pr
Prescription Use Only (Per 21 CFR 801:109)
(Division Sigh-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
5
510(k) Premarket Notification Aplio™ Artida (v2.0) SSH-880CV Ultrasound System
Diagnostic Ultrasound Indications For Use Form
System: Aplio Artida v2.0 SSH-880CV Transducer: PST-25SX
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 | TDI | CHI
2D | 4D
(Realtime
3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| 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 | | | | | P | | | | | P | |
| Cardiac Pediatric | P | | | | | P | | | | | P | |
| 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 *Combined mode includes B/M, B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Previous 510(k) of the transducer: K080160
Pr
Prescription Use (Per 21 CFR 801.109)
(División Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K090158
6
.
. .
Diagnostic Ultrasound Indications For Use Form
System: Aplio Artida v2.0 SSH-880CV Transducer:_ PST-30BT 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
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 | TDI | CHI
2D | 4D
(Realtime
3D) |
|------------------------------------------------|---|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----|-----------|------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | N | N | N | N | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| 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 | N | N | N | N | N | N | N | N | N | N | N | N |
| Cardiac Pediatric | N | N | N | N | N | N | N | N | N | N | N | N |
| 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 *Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Prescription Use Only (Per 21 CFR 801.109)
Tony M. Why
(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
7
.
Diagnostic Ultrasound Indications For Use Form
System: _ Aplio Artida v2:0 SSH-880CV Transducer: PST-30SBT
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 | TDI | CHI
2D | 4D
(Realtime
3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| 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 | P | P | P | P | P | P | | | P | P | |
| Cardiac Pediatric | P | P | P | P | P | P | P | | | P | P | |
| 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 *Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Previous 510(k) of the transducer: K080160
Prescription Use Only (Per 21 CFR 801.109)
Prescription
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
8
Diagnostic Ultrasound Indications For Use Form
System: Aplio Artida v2.0 SSH-880CV 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 | TDI | CHI
2D | 4D
(Realtime
3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| 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 | N | N | N | N | N | N | N | | | N | | |
| Cardiac Pediatric | N | N | N | N | N | N | N | | | N | | |
| 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 *Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Prescription Use Only (Per 21 CFR 801.109)
louis M. Whang
(Division Sigh-Off) Division of Reproductive, Abdominal and adiological Devices 09015 510(k) Number
·
关系
9
Diagnostic Ultrasound Indications For Use Form
System: Aplio Artida v2.0 SSH-880CV 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 | TDI | CHI | |||||||||
| 2D | 4D | |||||||||||
| (Realtime | ||||||||||||
| 3D) | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify) | ||||||||||||
| 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 | N | N | N | N | N | N | N | N | ||||
| Cardiac Pediatric | N | N | N | N | N | N | N | N | ||||
| 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 *Combined mode includes B/M; B/P/WD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Prescription Use Only (Per 21 CFR 801.109)
tony M. Whang
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
.
10
Diagnostic Ultrasound Indications For Use Form
System: __ Aplio Artida v2.0 SSH-880CV 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 | TDI | CHI
2D | 4D
(Realtime
3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | P | P | P | P | P | P | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | P | P | P | P | P | P | P | P | P | | | |
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | P | P | P | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | P | P | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix *Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Previous 510(k) of the transducer: K080160
Prescription
Prescription Use Only (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K090158
11
510(k) Premarket Notification Aplio™ Artida (v2.0) SSH-880CV Ultrasound System
Diagnostic Ultrasound Indications For Use Form
System: Aplio Artida v2.0 SSH-880CV Transducer: PET-511BTM
.
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 | TDI | CHI
2D | 4D
(Realtime
3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| 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 | P | P | | | P | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix *Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
-- ·
Previous 510(k) of the transducer: K080160
" "
Prescription Use Only (Per 21 CFR 801.109)
Longworth Withers
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices Kogo158 510(k) Number
12
Diagnostic Ultrasound Indications For Use Form
System: Aplio Artida v2.0 SSH-880CV Transducer:_ PC-20M
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 | TDI | CHI
2D | 4D
(Realtime
3D) |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| 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 *Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Previous 510(k) of the transducer: K080160
Proscription Use Only (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices K090158 510(k) Number __