(15 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
No
The device is intended for diagnostic imaging studies across various anatomical sites and not for treating conditions.
Yes
The device is an ultrasound system intended for various studies (fetal, abdominal, cardiac, etc.), which are typically performed to gather information for diagnosis.
No
The device description explicitly states it is a "mobile system" and employs "a wide array of probes," which are hardware components.
Based on the provided information, the Power Vision 6000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Power Vision 6000 Function: The description clearly states that the Power Vision 6000 is an Ultrasound System. Ultrasound systems use sound waves to create images of internal body structures. They do not analyze specimens taken from the body.
- Intended Use: The intended uses listed (fetal, abdominal, cardiac, etc.) are all related to imaging internal anatomy, which is consistent with an ultrasound device, not an IVD.
Therefore, the Power Vision 6000 is a medical imaging device, specifically an ultrasound system, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Power Vision 6000 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).
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
The PowerVision 6000 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transesophageal, peripheral vascular, musculo-skeletal
Indicated Patient Age Range
pediatric, neonatal, adult
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.
K933743, K943303, K963705, K964865, K970047, K981397
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.
K964865, K943303, K990490, K852159, K933473, K933743, K970047
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
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '991710'. The numbers are written in a simple, clear style, making them easily readable.
510(k) Summary of Safety and Effectiveness: 21 CFR 807.92 JUN 3 1999
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
|---|---|
| Address: | P.O. Box 2068,2441 Michelle Drive Tustin, CA 92781-2068 |
| Contact: | Paul Biggins, Regulatory Affairs Specialist |
| Telephone No.: | (714) 730-5000 |
Device Proprietary Name: SSA-370A/PowerVision 6000 Common Name: Ultrasound Imaging System
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, K964865,K970047,K981397
Device Description:
The PowerVision 6000 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 6000 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
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract appearance. The text is arranged to follow the curve of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left and "USA" on the right.
JUN 3 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Toshiba America Medical Systems c/o Carole Stamp TUV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891
Re: K991710 Trade Name: SSA-370A PowerVision 6000 Regulatory Class: 892.1560, 892.1560, 892.1570 Product Code: 90-IYO, 90-IYN, 90-ITX Classification: II Dated: May 18, 1999 May 19, 1999 Received:
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, Druq, 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 SSA-370A PowerVision 6000 as described in your premarket notification:
Transducer Model Numbers
PLM-703AT, PLM-503AT, PLM-805AT, PC-19M, PLF-308P, PSM-20CT, PSM-25AT, PSM-37AT, PSM-50AT, PSM-37CT, PVF-738F, PVF-738H, PVM-662AT, PEF-510MB, PVM-621VT, PVM-375AT, PVF-620ST.
If your device is classified (see above) into either class II (Special Controls) or class III (Pre-market 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 requlation 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.
2
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 Therefore, your product labeling must be consistent with FDA's CFR, Part 812. position on this use.
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 entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Robert Phillips, Ph.D. at (301) 594-1212.
Sincerely yours,
CAPT Daniel G. 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)
3
Diagnostic Ultrasound Indications For Use Form
Transducer____________________________________________________________________________________________________________________________________________________________________ System_X_ Model_________________________________________________________________________________________________________________________________________________________________________
. i
510(k) Number(s) _
ﺮ ﺍ
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Harmonic | |||||||||
| Imaging | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | n | n | n | n | n | n | n | n | n | |
| Abdominal | n | n | n | n | n | n | n | n | n | |
| Intraoperative (Specify) | n | n | n | n | n | n | n | |||
| Intraoperative Neurological | ||||||||||
| Pediatric | n | n | n | n | n | n | n | n | n | |
| Small Organ (Specify) | n | n | n | n | n | n | n | |||
| Neonatal Cephalic | n | n | n | n | n | n | n | n | ||
| Adult Cephalic | n | n | n | n | n | n | n | n | ||
| Cardiac | n | n | n | n | n | n | n | n | n | |
| Transesophageal | n | n | n | n | n | n | n | n | ||
| Transrectal | n | n | n | n | n | n | n | |||
| Transvaginal | n | n | n | n | n | n | n | |||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | n | n | n | n | n | n | n | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | n | n | n | n | n | n | n | |||
| Musculo-skeletal | n | n | n | n | n | n | n | |||
| 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
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTHER PAGES IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Device
510(k) Number . Prescription Use (Per 21 CFR 801.109)
4
Transducer Model Number: PVF-620ST 510(k) Control Number: K964865
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | P | P | P | P | |||
| Transvaginal | P | P | P | P | P | P | P | |||
| 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 PVK-720ST
. i
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON OTHER PAGES IF NEEPED Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT.
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K991710
5
Transducer Model Number: PVM-375AT 510(k) Control Number: K943303
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic 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)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI
Color Harmonic Imaging is applied to BDF and BDF/PWD modes NOTE: Original model number was PVK-357AT
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PACES IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
Radiological Devices
510(k) Number K991710
6
NEW TRANSDUCER TABLE
Transducer Model Number: PVM-621VT 510(k) Control Number:
| 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 | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | N | N | N | N | N | N | N | |||
| 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
IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON O Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number .
7
EXISTING TRANSDUCER TABLE Transducer Model Number: PEF-510MB 510(k) Control Number: K964865
| | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | P | P | P | P | P | P | P | P | |
| 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 PEF-511SA (K890969)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEGDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number.
8
NEW TRANSDUCER TABLE
Transducer Model Number: PVM-662AT 510(k) Control Number:
| 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 | N | N | N | N | N | N | N | N | |||
| Small Organ (Specify) | |||||||||||
| Neonatal Cephalic | N | 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) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K991710
9
Transducer Model Number: PVF-738H 510(k) Control Number: K990490
ﺎﻣﻴﺔ، ﺇ
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | P | |||
| Intraoperative (Specify) | P | P | P | P | P | P | P | |||
| 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 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Other (specify) |
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI
NOTE: Original model number was IOE-703H (K852159)
. :
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Signature
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _
10
Transducer Model Number: PVF-738F 510(k) Control Number: K990490
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | P | |||
| Intraoperative (Specify) | P | P | P | P | P | P | P | |||
| 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 | ||||||||||
| 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 IOE-703F (K852159)
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KPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON OTHER PAGES IF NEEDDEE Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
11
Transducer Model Number: PSM-37CT 510(k) Control Number: K933743
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Harmonic | |||||||||
| 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 | ||||||||||
| 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-37CT
(PLEASE DO NOT WRITTS BELOW THIS LINE CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) . i (Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
് 10(k) Number _
12
Transducer Model Number: PSM-50AT 510(k) Control Number: K933743
Mode of Operation PWD B M CWD Color Amplitude Color Combined Other A Clinical Application (Specify) Doppler (Specify) Doppler Velocity Imaging Ophthalmic Fetal Abdominal Intraoperative (Specify) Intraoperative Neurological E Pediatric 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)
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-50LT
. :
DI EASE DA NOT WATTE RELOW THIS LINE CONTINUE ONLOTHER DAGES IS NE Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device
510(k) Number K991710
13
Transducer Model Number: PSM-37AT 510(k) Control Number: K933743
ﺴﻴ
......
: 、
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| 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-37AT
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTHER PAGES IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K991710 |
|---|---|
| --------------- | --------- |
14
Transducer Model Number: PSM-25AT 510(k) Control Number: K933743
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Harmonic | |||||||||
| 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
Color Harmonic Imaging is applied to BDF and BDF/PWD modes
NOTE: Original model number was PSK-25AT
. i
SE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEED Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _
15
Transducer Model Number: PSM-20CT 510(k) Control Number: K970047
ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
| 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 | ||||||||||
| 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-20CT
. i
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON OTHER PAG. Concurrence of CDRH, Office of Device Evaluation (ODE
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number -
16
Transducer Model Number: PLF-308P 510(k) Control Number: K852159
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Harmonic | |||||||||
| Imaging | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | P | |||
| Intraoperative (Specify) | P | P | P | P | P | P | P | |||
| Intraoperative Neurological | ||||||||||
| Pediatric | 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)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; B-TDI; M-TDI
NOTE: Original model number was GCE-406M
. :
(PLEASE DO NOT WRITTE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number .
17
.
Transducer Model Number: PC-19M 510(k) Control Number: K933473
ﺎ
... .
| 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 | 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:
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTHER PAGES IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of Reproductive, Abdominal, ENT, and Radiological Devices
Prescription Use (Per 21 CFR 801.109)
510(k) Number ________________________________________________________________________________________________________________________________________________________________
18
Transducer Model Number: PLM-805AT 510(k) Control Number: K933743
198
| 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) | 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)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; B-TDI; M-TDI
NOTE: Original model number was PLK-703AT
. i
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON OTHER PAGES IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K991710
19
Transducer Model Number: PLM-503AT 510(k) Control Number: K933743
| 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) | 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)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; B-TDI; M-TDI
NOTE: Original model number was PLK-703AT
. i
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTHER PAGES IF NEEDE Concurrence of CDRH, Office of Device Evaluation (ODE)
Seth
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K991710
20
Transducer Model Number: PLM-703AT 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) | 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)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI
NOTE: Original model number was PLK-703AT
. ﻧ
(PLEASE DO NOT WRITTE BELOW THIS LINE CONTINUE ON OTHER Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrency of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
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510(k) Number K991710