(20 days)
Not Found
No
The summary describes a standard ultrasound system with various imaging modes and measurement capabilities, but there is no mention of AI or ML in the intended use, device description, or any other section.
No.
The device is described as a "diagnostic ultrasound system" intended for "clinical diagnosis purposes" and "Diagnostic ultrasound imaging or fluid flow analysis of the human body." It acquires data and displays it in various modes, all of which are for imaging and analysis rather than treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system provides "analysis packages that provide information that is used for clinical diagnosis purposes" and also mentions "Diagnostic ultrasound imaging or fluid flow analysis of the human body." Furthermore, the "Device Description" identifies the SONOLINE Elegra as a "diagnostic ultrasound system."
No
The device description explicitly states it is a "general purpose, mobile, software-controlled, diagnostic ultrasound system," indicating it includes hardware components (the ultrasound system itself) in addition to software.
No, this device is not an IVD (In Vitro Diagnostic).
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 about a person's health. This testing happens outside the body (in vitro).
- Device Description: The SONOLINE Elegra is described as a diagnostic ultrasound system that acquires ultrasound data and displays it in various modes. Ultrasound is a non-invasive imaging technique that uses sound waves to create images of structures inside the body.
- Intended Use/Indications for Use: The intended uses listed are all related to imaging and analyzing structures within the human body (e.g., Abdominal, OB/GYN, Vascular, Musculoskeletal). While it provides information for clinical diagnosis, it does so through imaging the body directly, not by testing samples taken from the body.
Therefore, based on the provided information, the SONOLINE Elegra is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SONOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications. The addition of 3-D Imaging will not add new indications for use to the Elegra. It will allow the user to display regions of interest in 3-dimensional format, either by showing views in three orthagonal planes or allowing surface rendering of objects.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral vessel, Musculo-skeletal Conventional.
For 2.0 CW probe: Fetal, Abdominal, Intraoperative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral vessel, Musculo-skeletal.
For 2.5PL20 Phased Array Transducer: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral vessel.
For 3.5PL28 Phased Array Transducer: Ophthalmic, Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Peripheral vessel.
For 3.5C40 Curved Array Transducer: Fetal, Abdominal, Pediatric, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional.
For 5.0HDPL40 Linear Array Transducer: Fetal, Abdominal, Pediatric, Peripheral vessel, Musculo-skeletal Conventional.
For 5.0C50 Curved Array Transducer: Fetal, Abdominal, Pediatric, Peripheral vessel, Musculo-skeletal Conventional.
For 6.5EC10 Curved Array Transducer: Small Organ, Transrectal, Transvaginal.
For 6.5EV13 Curved Array Transducer: Small Organ, Neonatal Cephalic, Transrectal, Transvaginal.
For 7.5C30 Curved Array Transducer: Fetal, Abdominal, Pediatric, Small Organ, Peripheral vessel, Musculo-skeletal Conventional.
For 7.5L40 Linear Array Transducer: Fetal, Abdominal, Intraoperative, Pediatric, Small Organ, Neonatal Cephalic, Peripheral vessel, Musculo-skeletal Conventional.
For 7.5PL13 Phased Array Transducer: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Peripheral vessel, Musculo-skeletal Conventional.
Product codes (comma separated list FDA assigned to the subject device)
90 IYN, 90 IYO, 90 ITX
Device Description
The SONOLINE Elegra is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular.
Indicated Patient Age Range
Neonatal/Adult Cephalic, Fetal, Pediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 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
MAY 2 7 1998 510(K) SUMMARY
Addition of 3 D Imaging to SONOLINE Elegra Diagnostic Ultrasound system
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
Submitted By: 1.
Siemens Medical Systems, Inc., Ultrasound Group 22010 S.E. 51st Street Issaquah, WA 98027-7002
Contact Person: Steve Hesler Manager of Regulatory Affairs (425) 557-1629
Date Prepared: March 31, 1998
-
- Proprietary Name: SONOLINE Elegra Advanced SONOLINE Elegra
Common/ Usual Name: Diagnostic Ultrasound System with Accessories
- Proprietary Name: SONOLINE Elegra Advanced SONOLINE Elegra
Classification Name: Ultrasonic Pulsed Doppler Imaging System (Product Code 90 IYN, 21 CFR 892.1550)
3. Predicate Device:
K945072, 11/21/95, cleared as the Q4000, marketed as the SONOLINE Elegra Advanced
K950517, 4/5/96, cleared as Q64XX, marketed as the SONOLINE Elegra K961833, 10/29/96, SieScape panoramic display for SONOLINE Elegra Advanced
4. Device Description:
The SONOLINE Elegra is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.
The SONOLINE ® Elegra, has been designed to meet the following product safety standards:
- UL 2601, Safety Requirements for Medical Equipment .
- CSA 22.2 No. 601-1, Safety Requirements for Medical Equipment .
- Standard for Real Time Display of Themal and Mechanical Indices on . Diagnostic Ultrasound Equipment, AlUM/NEMA, 1992.
- 93/42/EEC Medical Devices Directive
EN60601 = (IEC 601-1-1 + IEC 601-1-2), Safety and EMC Requirements for Medical Equipment
1
5. Intended Uses:
The SONOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications. The addition of 3-D Imaging will not add new indications for use to the Elegra. It will allow the user to display regions of interest in 3-dimensional format, either by showing views in three orthagonal planes or allowing surface rendering of objects.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Technological Comparison to Predicate Device: 6.
SONOLINE Elegra is a previously cleared device. The purpose of this submission is to receive clearance for the addition of 3 dimensional imaging to the already-cleared svstem. This real-time reconstruction technique is equivalent to the SieScape panaoramic imaging feature already cleared by 510(k) (see K961833, 10/29/96).
End of 510(k) Summary
t with 5
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a row.
MAY 2 7 1998
Siemens Medical Systems. Inc. Ultrasound Group c/o Joseph P. Murnane Underwriters Laboratories, Inc. 1285 Walt Whitman Road Melville, New York 11747-3081 Rc:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
K981626 Sonoline® Elegra Diagnostic Ultrasound System Dated: May 1, 1998 Received: May 7, 1998 Regulatory class: II Procodes: 90 IYN, 21 CFR 892.1550 90 IYO, 21 CFR 892.1560 90 ITX, 21 CFR 892. 1570
Dear Mr. Murnane:
We have reviewed your Section 510%) 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 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 Festeral 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 agginst misbranding and adulteration.
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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devise in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electrotic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) 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 the 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) 594-4613. 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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.html".
Sincerely yours,
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
510 (k) Number (if
known) :
SONOLINE Elegra with SieScape and 3 D Imaging Device Name :
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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 | P | P | P | | BMDC (P) | |
| Abdominal | | P | P | P | P | P | P | | BMDC (P) | |
| Intraoperative
(Specify) | | P | P | P | P | P | P | | BMDC (P) | |
| Pediatric | | P | P | P | P | P | P | | BMDC (P) | |
| Small Organ
(Specify) | | P | P | P | P | P | P | | BMDC (P) | |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC (P) | |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC (P) | |
| Cardiac | | P | P | P | P | P | P | | BMDC (P) | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | P | P | P | | BMDC (P) | |
| Transvaginal | | P | P | P | P | P | P | | BMDC (P) | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC (P) | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | P | P | P | | BMDC (P) | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication;
P = previously cleared by FDA;
E = added
under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David G. Seymore
(Division Sign-Off)
(Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K981626
4
510 (k) Number (if
known) :
2.0 CW probe Device Name :
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | P | | | | | |
| Abdominal | | | | | P | | | | | |
| Intraoperative
(Specify) | | | | | P | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ
(Specify) | | | | | P | | | | | |
| Neonatal Cephalic | | | | | P | | | | | |
| Adult Cephalic | | | | | P | | | | | |
| Cardiac | | | | | P | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | P | | | | | |
| Transvaginal | | | | | P | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | P | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
under Appendix E
Additional Comments:___
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Severson
(Division Sign-Off)
(Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K481626
5
510 (k) Number (if
known) :
2.5PL20 Phased Array Transducer Device Name :
Intended Use:
2.5F E20 Friased Aray andy or fluid flow analysis of the human body as follows:
Mode of Operation
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | |
|----------------------------------------------------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | E | E | E | E | | E | | BMDC (E) | | |
| Abdominal | | E | E | E | E | | E | | BMDC (E) | | |
| Intraoperative
(Specify) | | | | | | | | | | | |
| Pediatric | | E | E | E | E | E | E | | BMDC (E) | | |
| Small Organ
(Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | E | E | E | E | E | E | | BMDC (E) | | |
| Adult Cephalic | | E | E | E | E | E | E | | BMDC (E) | | |
| Cardiac | | E | E | E | E | E | E | | BMDC (E) | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | E | E | E | E | E | | E | | BMDC (E) | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| N = new indication; P = previously cleared by FDA; E = added
under Appendix E
Additional Comments: | | | | | | | | | | | |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Segerson
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number _ K981626
6
510 (k) Number (if
known) :
3.5PL28 Phased Array Transducer Device Name :
Intended Use:
5.5F E20 Thused Airay Truid flow analysis of the human body as follows:
Mode of Operation
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|--------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | P | P | P | P | | BMDC (P) | |
| Fetal | | P | P | P | P | P | P | | BMDC (P) | |
| Abdominal | | P | P | P | P | | P | | BMDC (P) | |
| Intraoperative
(Specify) | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC (P) | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC (P) | |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC (P) | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC (P) | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| N = new indication; P = previously cleared by FDA; E = added | | | | | | | | | | |
| under Appendix E | | | | | | | | | | |
| Additional Comments: | | | | | | | | | | |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Jarid a. Jesson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
981626 510(k) Number
7
510 (k) Number (if
known) :
3.5C40 Curved Array Transducer Device Name :
Intended Use:
3.5040 Cul ved Array Transade of the data visis of the human body as follows:
Mode of Operation
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | E | E | E | E | E | BMDC (E) | ||||
| Abdominal | E | E | E | E | E | BMDC (E) | ||||
| Intraoperative (Specify) | ||||||||||
| Pediatric | E | E | E | E | E | BMDC (E) | ||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | E | E | E | E | E | BMDC (E) | ||||
| Laparoscopic | E | E | E | E | E | BMDC (E) | ||||
| Musculo-skeletal Conventional | E | E | E | E | E | |||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) | ||||||||||
| N = new indication; P = previously cleared by FDA; E = added under Appendix E Additional Comments: |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lyons
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K487422
8
510 (k) Number (if known) : Device Name :
5.0HDPL40 Linear Array Transducer
Diagnostic ultrasound imaging or fluid flow analysis of the Intended Use: human body as follows:
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 | | P | P | | BMDC (P) | |
| Abdominal | | P | P | P | | P | P | | BMDC (P) | |
| Intraoperative
(Specify) | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC (P) | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC (P) | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMDC (P) | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication;
P = previously cleared by FDA;
E = added
under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Bergman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K981626
9
510 (k) Number (if known) :
5.0C50 Curved Array Transducer Device Name :
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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 | | P | P | | BMDC (P) | |
| Abdominal | | P | P | P | | P | P | | BMDC (P) | |
| Intraoperative
(Specify) | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC (P) | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC (P) | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMDC (P) | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| N = new indication: P = previously cleared by FDA: E = added | | | | | | | | | | |
under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Hanson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K981626
10
510 (k) Number (if
known) :
6.5EC10 Curved Array Transducer Device Name :
Diagnostic ultrasound imaging or fluid flow analysis of the Intended Use: human body as follows:
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) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | E | E | E | | E | E | | BMDC (E) | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | E | E | E | | E | E | | BMDC (E) | |
| Transvaginal | | E | E | E | | E | E | | BMDC (E) | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| N = new indication; P = previously cleared by FDA; E = added
under Appendix F | | | | | | | | | | |
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seigman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K981626
11
510 (k) Number (if
known) :
6.5EV13 Curved Array Transducer Device Name :
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | P | P | P | | P | P | | BMDC (P) | |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC (P) | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC (P) | |
| Transvaginal | | P | P | P | | P | P | | BMDC (P) | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seymon
(Division Sign-Off) (Porision of Reproductive, Abdominal, ENT,
and Radiological Devices and Radiological Devices
510(k) Number K981626
12
510 (k) Number (if known) : Device Name :
7.5C30 Curved Array Transducer
Diagnostic ultrasound imaging or fluid flow analysis of the Intended Use: human body as follows:
Mode of Operation
| Clinical | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|--------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Application | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | E | E | E | | E | E | | BMDC (E) | |
| Abdominal | | E | E | E | | E | E | | BMDC (E) | |
| Intraoperative | | | | | | | | | | |
| (Specify) | | | | | | | | | | |
| Pediatric | | E | E | E | | E | E | | BMDC (E) | |
| Small Organ | | E | E | E | | E | E | | BMDC (E) | |
| (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | E | E | E | | E | E | | BMDC (E) | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | E | E | E | | E | E | | BMDC (E) | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| N = new indication; P = previously cleared by FDA; E = added | | | | | | | | | | |
under Appendix E Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Thail G. Seyman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K 78/626
(
13
510 (k) Number (if
known) :
7.5L40 Linear Array Transducer Device Name :
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
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 | | P | P | | BMDC (P) | |
| Abdominal | | P | P | P | | P | P | | BMDC (P) | |
| Intraoperative
(Specify) | | P | P | P | | P | P | | BMDC (F) | |
| Pediatric | | P | P | P | | P | P | | BMDC (P) | |
| Small Organ
(Specify) | | P | P | P | | P | P | | BMDC (P) | |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC (P) | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC (P) | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | BMDC (P) | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| N = new indication. D = previously cleared by FDA. E = added. | | | | | | | | | | |
under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Hind G. Hyam
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number_K481626
14
510 (k) Number (if
known) :
7.5PL13 Phased Array Transducer Device Name :
Diagnostic ultrasound imaging or fluid flow analysis of the Intended Use: human body as follows:
Mode of Operation
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | E | E | E | E | E | E | | BMDC (E) | |
| Abdominal | | E | E | E | E | E | E | | BMDC (E) | |
| Intraoperative
(Specify) | | | | | | | | | | |
| Pediatric | | E | E | E | E | E | E | | BMDC (E) | |
| Small Organ
(Specify) | | E | E | E | E | E | E | | BMDC (E) | |
| Neonatal Cephalic | | E | E | E | E | E | E | | BMDC (E) | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | E | E | E | E | E | E | | BMDC (E) | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | E | E | E | E | E | E | | BMDC (E) | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication;
P = previously cleared by FDA;
E = added
under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Thind le. Beynam
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K981626