SSA-390A/POWER VISION 8000
Device Facts
| Record ID | K991858 |
|---|---|
| Device Name | SSA-390A/POWER VISION 8000 |
| Applicant | Toshiba America Medical Systems, In.C |
| Product Code | IYN · Radiology |
| Decision Date | Jun 16, 1999 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The Power Vision 8000 is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transesophageal, peripheral vascular, and musculo-skeletal (both conventional and superficial).
Device Story
Mobile diagnostic ultrasound system; utilizes wide array of probes (flat linear, convex linear, sector) with 2-10 MHz frequency range. Inputs: acoustic signals from patient tissue. Processing: ultrasonic pulsed echo and Doppler imaging; transforms signals into real-time visual images. Outputs: B-mode, M-mode, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, and Harmonic Imaging. Used in clinical settings by trained healthcare professionals. Output displayed on monitor for diagnostic assessment; assists in clinical decision-making across various anatomical regions. Benefits: non-invasive visualization of internal structures and blood flow.
Clinical Evidence
No clinical data. Substantial equivalence is based on bench testing, including acoustic output measurements compliant with AIUM-NEMA UD2 and UD3 standards, and engineering assessments comparing the subject device to the predicate system.
Technological Characteristics
Mobile ultrasound system; Track 3 device. Transducers: flat linear, convex linear, sector arrays (2-10 MHz). Compliance: IEC 60601, AIUM-NEMA UD2 (acoustic output), AIUM-NEMA UD3 (display). Imaging modes: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity, Harmonic Imaging. Sterilization: per manufacturer instructions for transducers.
Indications for Use
Indicated for diagnostic ultrasound imaging in fetal, abdominal, intraoperative, pediatric, small organ, neonatal/adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vascular, and musculoskeletal applications. Contraindicated for in vitro fertilization and percutaneous umbilical blood sampling.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- SSA-380A/PowerVision 7000 (K933743, K943303, K963705, K964805, K970047, K981397)
Related Devices
- K013633 — SSA-770A, APLIO ULTRASOUND SYSTEM · Toshiba America Medical Systems, In.C · Nov 13, 2001
- K133277 — XARIO 100 · Toshibamedical Systems Corporation · Jan 17, 2014
- K093171 — VIAMO SSA-640A VERSION 1.2 · Toshiba America Medical Systems, In.C · Dec 4, 2009
- K092948 — APLIO MX SSA-780A, VERSION 1.0 · Toshiba America Medical Systems, In.C · Oct 9, 2009
- K131507 — XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM · Toshibamedical Systems Corporation · Aug 28, 2013
Submission Summary (Full Text)
{0}------------------------------------------------
K991858
#### JUN 1 6 1999 510(k) Summary of Safety and Effectiveness: 21 CFR 807.92
| <b>Submitter's Name:</b> | Toshiba America Medical Systems, Inc. |
|--------------------------|-------------------------------------------------------|
| <b>Address:</b> | PO Box 2068,2441 Michelle Drive Tustin, CA 92781-2068 |
| <b>Contact:</b> | Paul Biggins, Regulatory Affairs Specialist |
| <b>Telephone No.:</b> | (714) 730-5000 |
Device Proprietary Name: SSA-390A/PowerVision 8000 Ultrasound Imaging System Common Name:
# Classification:
:
| Regulatory Class: | II |
|-------------------|---------|
| Review Category: | Tier II |
Ultrasonic Pulsed Doppler Imaging System - Procode: 90-IYN [Fed.Reg.No .: 892.1550] Ultrasonic Pulsed Echo Imaging System - Procode: 90-IYO [Fed.Reg.No .: 892.1560] Diagnostic Ultrasonic Transducer - Procode: 90-ITX [Fed. Reg. No .: 892.1570]
# Identification of Predicate Devices:
Toshiba America Medical Systems believes that this device is substantially equivalent to the SSA-380A/PowerVision 7000, 510(k) control numbers K933743,K943303, K963705, K964805,K970047,K981397
## Device Description:
The PowerVision 8000 Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 10 MHz.
## Intended Use:
The Power Vision 8000 is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transesophageal, peripheral vascular, and musculo-skeletal (both conventional and superficial).
## Safety Considerations:
This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601 (applicable portions), the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard. This unit is similar to that of the Toshiba SSA-380A/PowerVision 7000 and engineering assessments identify no new issues of risk or safety.
{1}------------------------------------------------
IIII
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 16 1999
Toshiba America Medical Systems, Inc. C/O Carole Stamp 510(k) Program Manager TUV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891
K991858 RE:
SSA-390A PowerVision 8000 Diagnostic Ultrasound System Dated: May 28, 1999 Received: June 21, 1999 Regulatory Class: II 21 CFR 892.1550/Procode: 90 IYN 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1570/Procode: 90 ITX
Dear Ms. Stamp:
We have reviewed your Section 510(k) 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 also applies to the following transducers intended for use with the SSA-390A Power Vision 8000 Diagnostic Ultrasound System as described in your premarket notification:
Transducer Model Number(s):
PSN-20CT, PSN-37CT, PSN-25AT, PSN37AT, PSN-50AT, PSN-70AT, PLN-503AT, PLN-703AT, PLN-805AT, PVN-375AT, PVM-656AT, PVN-672AT, PC-19M, PLF-308P, PVF-738F, PVF-738H, PVF-745V, PVM-740RT, PEF-5190MB, PEK-510MB, PVN-661VT and PVN-760ST
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page -2 -- Ms. Carole Stamp
Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.
This determination of substantial equivalence is granted on the condition that prior to shipping of the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurement based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturer's Seeking Marketing Clearance of Diagnostic Ultrasound System and Transducers." If the special report is incomplete or contains unacceptable values, (e.g., not apply to the production units which is a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked as " ADD TO FILE" and should be submitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entifled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
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Page -3 - Ms. Carole Stamp
If you have any questions regarding the content of this letter, please contact Robert Phillips, Ph.D at (301) 594-1212.
Sincerely yours,
David li. dyarm
hn
CAPT Daniel Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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# Diagnostic Ultrasound Indications For Use Form
Transducer____________________________________________________________________________________________________________________________________________________________________ System _X Model_ SSA-390A 510(k) Number(s) __
| | | Mode of Operation | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
| Ophthalmic | n | n | n | n | n | n | n | n | n | n |
| Fetal | n | n | n | n | n | n | n | n | n | n |
| Abdominal | n | n | n | n | n | n | n | n | n | n |
| Intraoperative (Specify) | n | n | n | n | n | n | n | n | n | n |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | n | n | n | n | n | n | n | n | n | n |
| Small Organ (Specify) | n | n | n | n | n | n | n | n | n | |
| Neonatal Cephalic | n | n | n | n | n | n | n | n | n | |
| Adult Cephalic | n | n | n | n | n | n | n | n | n | |
| Cardiac | n | n | n | n | n | n | n | n | n | n |
| Transesophageal | n | n | n | n | n | n | n | n | n | |
| Transrectal | n | n | n | n | n | n | n | n | n | |
| Transvaginal | n | n | n | n | n | n | n | n | n | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | n | n | n | n | n | n | n | n | n | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | n | n | n | n | n | n | n | n | n | |
| Musculo-skeletal | n | n | n | n | n | n | n | n | n | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; Additional Comments: BDF/MDF/PWD;B-TDI; M-TDI
> SEE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTHER Concurrence of CDRH, Office of Device Evaluation
David A. Slegmm
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological I
510(k) Number Prescription Use (Per 21 CFR 801.109)
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Transducer Model Number: PSN-20CT 510(k) Control Number: K970047
| | Mode of Operation | | | | | | | | | |
|------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | P | P | |
| Adult Cephalic | | P | P | P | P | P | P | P | P | |
| Cardiac | | P | P | P | P | P | P | P | P | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI
NOTE: Original model number was PSK-20C
PLEASE DO NOT WRITTE BELOW THIS LINE-CONTINUE ON Concurrence of CDRH, Office of Device Eval
Vland A. Legrim
(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological De 510(k) Number
{6}------------------------------------------------
Transducer Model Number: PSN-37CT 510(k) Control Number: K933743
| | | Mode of Operation | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | E | E | E | E | E | E | E | E | E | |
| Abdominal | E | E | E | E | E | E | E | E | E | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | E | E | E | E | E | E | E | E | E | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | E | E | E | E | E | E | E | E | E | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI
NOTE: Original model number was PSK-37CT
(PLEASE DO NOT WRITTS BELOW THIS LINE-CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number _
{7}------------------------------------------------
Transducer Model Number: PSN-25AT 510(k) Control Number: K933743
| | Mode of Operation | | | | | | | | | |
|------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | P | P | P |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | P | P | P |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; Additional Comments: BDF/MDF/PWD;B-TDI; M-TDI
NOTE: Original model number was PSK-25AT
Color Harmonic Imaging is applied to BDF & BDF/PWD Modes
Concurrence of CDRH, Office of Device Evaluation (ODE) 49451
David W. Ayres
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devic 510(k) Number
{8}------------------------------------------------
# Transducer Model Number: PSN-37AT 510(k) Control Number: K933743
| | | Mode of Operation | | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | E | E | E | E | E | E | E | E | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | E | E | E | E | E | E | E | E | E | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; Additional Comments: BDF/MDF/PWD;B-TDI; M-TDI
NOTE: Original model number was PSK-37AT
(PLEASE DO NOT WRITTE DELOW THIS LINE -- CONTINUE ON OTHER PAGES IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Elvin A. Lyons
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number .
{9}------------------------------------------------
# Transducer Model Number: PSN-50AT 510(k) Control Number: K933743
| | | Mode of Operation | | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | E | E | E | E | E | E | E | E | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | E | E | E | E | E | E | E | E | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | E | E | E | E | E | E | E | E | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; Additional Comments: BDF/MDF/PWD;B-TDI; M-TDI
NOTE: Original model number was PSK-50AT
(PLEASE DO NOT WRITTS RELOW THIS LINE-CONTINUE ON OTHER PAGES IF NEFFICED Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
{10}------------------------------------------------
# Transducer Model Number: PSN-70AT 510(k) Control Number: K933743
| | | Mode of Operation | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | E | E | E | E | E | E | E | E | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | E | E | E | E | E | E | E | E | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | E | E | E | E | E | E | E | E | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; Additional Comments: BDF/MDF/PWD;B-TDI; M-TDI
NOTE: Original model number was PSK-70LT
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTHER Concurrence of CDRH, Office of Device Evaluation (C
David A. Lugann
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Dev
s10(k) Number K911834
{11}------------------------------------------------
## Transducer Model Number: PLN-503AT 510(k) Control Number: K933743
| | | Mode of Operation | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | E | E | E | | E | E | E | E | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | E | E | E | | E | E | E | E | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | E | E | E | | E | E | E | E | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; Additional Comments: BDF/MDF/PWD;B-TDI; M-TDI
NOTE: Original model number was PLK-703AT
ISLE ASE DO NOT WAITE DELOW THIS LINE CONTINUE ON OTHER DAGES IS NEEDERS Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Device 510(k) Number
{12}------------------------------------------------
# Transducer Model Number: PLN-703AT 510(k) Control Number: K933743
| | | Mode of Operation | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | P | P | P | | P | P | P | P | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | P | P | P | | P | P | P | P | |
| Musculo-skeletal | | P | P | P | | P | P | P | P | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; Additional Comments: _BDF/MDF/PWD;B-TDI; M-TDI
NOTE: Original model number was PLK-703AT
PLEASE DO NOT WRITTS BELOW THIS LINE CONTINUE ON OTHER PAGES IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Elind M. Segura
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number J
{13}------------------------------------------------
# Transducer Model Number: PLN-805AT 510(k) Control Number: K933743
| Clinical Application | Mode of Operation | | | | | | | | | |
|------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | E | E | E | | E | E | E | E | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | E | E | E | | E | E | E | E | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | E | E | E | | E | E | E | E | |
| Musculo-skeletal | | E | E | E | | E | E | E | E | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; Additional Comments: BDF/MDF/PED; B-TDI; M-TDI
NOTE: Original model number was PLK-703AT
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTANUE ON OTHER PAGES IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Nygren
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number
{14}------------------------------------------------
Transducer Model Number: PVN-375AT
510(k) Control Number: K943303
| | | Mode of Operation | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P | P |
| Abdominal | | P | P | P | | P | P | P | P | P |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | P | P | P |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; Additional Comments: BDF/MDF/PWD;B-TDI; M-TDI
NOTE: Original model number was PVK357AT
Color Harmonic Imaging is applied to BDF & BDF/PWD Modes
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTHER PAGES IF NEEDE
Concurrence of CDRH, Office of Device Evaluation (ODE)
ep
David Myers
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number
{15}------------------------------------------------
# NEW TRANSDUCER TABLE
Transducer Model Number: PVM-656AT 510(k) Control Number:
| | Mode of Operation | | | | | | | | | |
|------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | N | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; Additional Comments: BDF/MDF/PWD;B-TDI; M-TDI
Concurrence of CDRH, Office of Device Evaluation
David L. Segura
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number .
{16}------------------------------------------------
# NEW TRANSDUCER TABLE
Transducer Model Number: PVN-672AT 510(k) Control Number:
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
|------------------------------|---|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | N | N | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | N | N | N | | N | N | N | N | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI
> SELL OW THE LINE CONTINUE ON OTHER D Concurrence of CDRH, Office of Device Evaluation (ODE)
Edward A. Ingram
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number .
{17}------------------------------------------------
Transducer Model Number: PC-19M 510(k) Control Number: K933473
| | | Mode of Operation | | | | | | | | |
|------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | P | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments:_________________________________________________________________________…
