(14 days)
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific AI/ML-driven features.
No
The device is described as an "Ultrasound System" intended for "fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular, and musculo-skeletal" studies, which are diagnostic imaging purposes, not therapeutic interventions.
Yes
The device is an ultrasound system intended for studies of various anatomical sites (fetal organ, abdominal, cardiac, etc.). Ultrasound is an imaging modality used by healthcare professionals to visualize internal body structures for medical assessment, which is a diagnostic purpose.
No
The device description explicitly states it is an "Ultrasound System" available as a "compact portable system" or "mobile system with a 12 inch monitor" and employs "a wide array of probes." These are hardware components, not solely software.
Based on the provided information, the JustVision Ultrasound System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used for various types of in vivo (within a living organism) ultrasound studies on different anatomical sites. IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside of a living organism) to diagnose or monitor conditions.
- Device Description: The description details an ultrasound system with probes, which is a typical medical imaging device used for visualizing internal structures of the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples or perform tests on specimens.
Therefore, the JustVision Ultrasound System is a medical imaging device used for diagnostic purposes, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The JustVision is intended to be used for the following type of studies; fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular, and musculo-skeletal (both conventional and superficial).
Product codes
90-IYO, 90 ITX
Device Description
The JustVision Ultrasound System is available as a compact portable system or can be configured as a mobile system with a 12 inch monitor. This system is a Track 1 device that employs a wide array of probes that include flat linear array and convex linear 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 organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular, musculo-skeletal (both conventional and superficial).
The following specific transducers have additional indications:
- PVG-366M: Fetal, Abdominal.
- PVG-381M: Fetal, Abdominal, Cardiac.
- PVG-681S: Abdominal, Neonatal Cephalic.
- PVG-600S: Transrectal.
- PVG-601V: Fetal, Transvaginal.
- PVG-720S: Fetal, Small Organ, Peripheral Vascular, Musculo-skeletal Superficial, Musculo-skeletal Conventional.
- PVF-738F: Abdominal, Intraoperative, Small Organ, Peripheral Vascular, Musculo-skeletal Superficial, Musculo-skeletal Conventional.
- PVF-738H: Abdominal, Intraoperative, Small Organ, Peripheral Vascular, Musculo-skeletal Superficial, Musculo-skeletal Conventional.
- PVF-745V: Abdominal, Intraoperative, Small Organ, Neonatal Cephalic, Peripheral Vascular, Musculo-skeletal Superficial, Musculo-skeletal Conventional.
- PLG-308P: Abdominal.
- PLG-506M: Small Organ, Musculo-skeletal Superficial, Musculo-skeletal Conventional.
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
3/2/99
q90490
510(k) Summary of Safety and Effectiveness: 21 CFR 807.92
| 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 |
Just Vision 200 and Just Vision 400 Device Proprietary Name: Common Name: Ultrasound Imaging System
Classification:
Regulatory Class: II Review Category: Tier II Ultrasonic Pulsed Echo Imaging System [Fed.Reg.No .: 892.1560,Pro.Code:90-IYO]
Identification of Predicate Devices:
Toshiba America Medical Systems believes that this device is substantially equivalent to the SSA-220A Capasee, 510(k) control number K933747
Device Description:
The JustVision Ultrasound System is available as a compact portable system or can be configured as a mobile system with a 12 inch monitor. This system is a Track 1 device that employs a wide array of probes that include flat linear array and convex linear array, with a frequency range of approximately 2 MHz to 10 MHz.
Intended Use:
The JustVision is intended to be used for the following type of studies; fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular, and musculo-skeletal (both conventional and superficial).
Safety Considerations:
This device is designed and manufactured in conjunction with the Quality System Regulation, ISO- 60601 (applicable portions) and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 1 Ultrasound systems. This unit is similar to that of the Toshiba SSA-220A Capasee and engineering assessments identify no new issues of risk or safety.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem that features three stylized human figures, possibly representing people, in a flowing, abstract design.
MAR - 2 1999
Toshiba America Medical Systems, Inc. C/o Carole Stamp TUV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891
K990490 Re: SSA-320A JustVision 200 and SSA-325A JustVision 400 Regulatory Class: II/ 21 CFR 892.1560/21 CFR 892.1570 Product Code: 90 IYO/ 90 ITX Dated: February 11, 1999 Received: February 16, 1999
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 applies to the following transducers intended for use with the SSA-320A JustVision 200 and SSA-325A JustVision 400, as described in your premarket notification:
Transducer Model Number PVG-366M PVG-381M PVG-681S PVG-600S PVG-601V PVG-720S PVG-738F PVF-738H PVF-745V PLG-308P PLG-506M
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 (OS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic OS 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.
2
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded. 1. 1. 1. 1. 1. 18. 1. 18. 1. 1. 1. 1. 1. 1. 1. 1.
有限公司 > 上一篇: 上一篇:
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "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 entitled, "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".
If you have any questions regarding the content of this letter, please contact Robert A. Phillips, Ph.D. at (301) 594-1212.
Sincerely vours.
Kamil A. Seymann
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
Enclosures
3
Transducer_ System X_ Model____SSA -320A/SSA-325A_ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number(s) _____________________________________________________________________________________________________________________________________________________________
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | n | n | n | |||||||
| Abdominal | n | n | n | |||||||
| Intraoperative (Specify) | n | n | n | |||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | n | n | n | |||||||
| Small Organ (Specify) | n | n | n | |||||||
| Neonatal Cephalic | n | n | n | |||||||
| Adult Cephalic | ||||||||||
| Cardiac | n | n | n | |||||||
| Transesophageal | ||||||||||
| Transrectal | n | n | n | |||||||
| Transvaginal | n | n | n | |||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | n | n | n | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | n | n | n | |||||||
| Musculo-skeletal | ||||||||||
| Conventional | n | n | n | |||||||
| Other (specify) |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: _________________________________________________________________________________________________________________________________________________________
and the comments of the comments of the comments of the comments of the comments of ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER CCC IS NEDDED --Concyfrence of CDRH, Office of Device Evaluation (ODE)
David A. Segner
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Device
Radiological Devices
510(k) Number K990490
4
Transducer_x__ System PVG-366M Model_ 510(k) Number(s) _
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | P | P | ||||||||
| Abdominal | P | P | P | ||||||||
| 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)
Additional Comments: Combined mode is B+M
Note: This transducer was originally cleared with the SSA-220A via 510(k) control number K933747
Concerrence of CDRH. Office of Device Evaluatio
David G. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
2
5
Transducer_x System ___ PVG-381M_ Model 510(k) Number(s) _
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | P | P | ||||||||
| Abdominal | P | P | P | ||||||||
| Intraoperative (Specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | 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 mode is B+M
Note: This transducer was originally cleared with the SSA-220A via 510(k) control number K933747
Concurrence of CDRH. Office of Device Evalua
David A. Syzmon
(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devi 510(k) Number
6
Transducer_X System _ Model_ PVG-681S_ 510(k) Number(s) __
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | N | N | N | ||||||||
| Intraoperative (Specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify) | |||||||||||
| Neonatal Cephalic | 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 mode is B+M
Device Evaluat
Uhmil A. Syonn
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109)
4
7
System _ Transducer_X__ PVG-600S Model
510(k) Number(s) __
| 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 | N | N | N | ||||||||
| 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 mode is B+M
Note: This transducer was originally cleared with the SSA-140A via 510(k) control number
Concurrence of CDRH. Office of Device Evaluatio
David A. Seznor
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev
510(k) Number K140440
8
Transducer_X_ System _ PVG-601V Model 510(k) Number(s) _
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | |||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | 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 mode is B+M
Note: This transducer was originally cleared with the SSA-220A via 510(k) control number K933747
4PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON OTHER PA Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Tegner
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number
9
System _ Transducer_X_ -PVG-720S Model_ 510(k) Number(s) _
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | |||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | N | N | N | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | N | N | N | |||||||
| Musculo-skeletal | P | P | P | |||||||
| Conventional | ||||||||||
| Other (specify) | ||||||||||
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined mode is B+M
Note: This transducer was originally cleared with the SSA-220A via 510(k) control number
Concurrence of CDRH, Office of Device Evaluatio
David G. Segner
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number
10
Transducer_X System PVF-738F Model ______________________________________________________________________________________________________________________________________________________________________________ 510(k) Number(s) _____________________________________________________________________________________________________________________________________________________________
| 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 | |||||||
| Intraoperative (Specify) | P | P | P | |||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | P | P | P | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | N | N | N | |||||||
| Musculo-skeletal | N | N | N | |||||||
| Conventional | ||||||||||
| Other (specify) | ||||||||||
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined mode is B+M
Note: This transducer was originally cleared as probe IOE-703F with the SSA-90A via 510(k) control number K852159
PLACE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (C
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K990490
Prescription Use (Per 21 CFR 801.109)
8
11
System __ Transducer_X_ PVF-738H_ Model ______________________________________________________________________________________________________________________________________________________________________________
510(k) Number(s) __
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | |||||||
| Intraoperative (Specify) | P | P | P | |||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | P | P | P | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | N | N | N | |||||||
| Musculo-skeletal | N | N | N | |||||||
| Conventional | ||||||||||
| Other (specify) | ||||||||||
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined mode is B+M
Note: This transducer was originally cleared as probe IOE-703H with the SSA-90A via 510(k) control number K852159
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER DALES IN NECKED Concurrence of CDRH, Office of Device Evaluation (ODE)
Clint G. Seppam
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devic
510(k) Number K992446
9
12
System __ __ Transducer_X_ Model_ PVF-745V 510(k) Number(s) _
| 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 | |||||||
| Intraoperative (Specify) | P | P | P | |||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | P | P | P | |||||||
| Neonatal Cephalic | N | N | N | |||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | N | N | N | |||||||
| Musculo-skeletal | N | N | N | |||||||
| Conventional | ||||||||||
| Other (specify) | ||||||||||
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined mode is B+M
Note: This transducer was originally cleared as probe IOE-703F with the SSA-90A via 510(k) control number K852159
Concurrence of CDR
David G. Segner
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Devi
510(k) Number K990445
13
Transducer_X_ System _ Model_ PLG-308P 510(k) Number(s) _
| 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 | |||||||
| 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)
Additional Comments: Combined mode is B+M
Note: This transducer was originally cleared as probe GCE-406M With the SSA-90A via 510(k)
| control number | K852159 |
|---|---|
| ---------------- | --------- |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE Concurrence of CDRH, Office of Device Evaluation
David A. Sezmann
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K990440
14
Transducer_X_ System _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ PLG-506M Model_ 510(k) Number(s) _
| 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) | N | N | N | ||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Superficial | N | N | N | ||||||||
| Musculo-skeletal | N | N | N | ||||||||
| Conventional | |||||||||||
| Other (specify) |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined mode is B+M
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number .