(32 days)
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific algorithms associated with AI/ML processing of images or data. The description focuses on standard ultrasound modes and hardware.
No
The 'Intended Use / Indications for Use' section states "Diagnostic ultrasound imaging or Doppler analysis of the human body", indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or Doppler analysis of the human body". Furthermore, the "Device Description" calls it a "mobile diagnostic ultrasound system."
No
The device description explicitly states it is a "mobile diagnostic ultrasound system" with "flat linear array, convex linear" and a frequency range, indicating it includes hardware components (transducers and the system itself) in addition to any potential software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The description clearly states the sarano is a "mobile diagnostic ultrasound system." Ultrasound is an imaging modality that uses sound waves to create images of structures inside the body.
- Intended Use: The intended use lists various anatomical sites for imaging and Doppler analysis within the human body.
Therefore, based on the provided information, the sarano is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The sarano is intended for the following applications: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.
Product codes
90-IYO, 90-ITX
Device Description
The sarano is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, or in a combination of modes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial, Musculo-skeletal Conventional, Transrectal
Indicated Patient Age Range
Fetal, Pediatric, Neonatal (Cephalic), Adult (Cephalic)
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)
Shimadzu Corporation SDU-1100 (K050510, 4/1/05)
Reference Device(s)
Not Found
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
KD61641
JUL 1 4 2006
510(k) Summary
1.0 SUBMITTER INFORMATION
1.1 Submitter: SHIMADZU MEDICAL SYSTEMS 20101 South Vermont Ave. Torrance, CA 90502-1328 PH: 310-217-8855 FX: 310-217-8869
1.2 Contact: Randal Walker
- 1.3 Date: March 31, 2006
2.0 DEVICE NAME
| 2.1 Proprietary Name: | sarano |
|---|---|
| 2.2 Common Name: | Ultrasound Imaging System |
| 2.3 Classification: | Ultrasonic Pulsed Echo Imaging System |
| FR # 892.1560, Product Code 90-IYO | |
| Diagnostic Ultrasound Transducer | |
| FR # 892.1570, Product Code 90-ITX | |
| 2.4 Predicate Device: | Shimadzu Corporation SDU-1100 (K050510, 4/1/05) |
3.0 DEVICE DESCRIPTION
The sarano is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, or in a combination of modes.
4.0 INTENDED USE
The sarano is intended for the following applications: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.
1
5.0 SAFETY CONSIDERATIONS
The sarano has been designed to meet the following voluntary and measurement standards:
- . IEC 60601-1 Safety of Medical Electric Equipment
- AIUM NEMA UD2 Acoustic Output Measurement Standard for Diagnostic . Ultrasound Equipment
- Acoustic Output Measurement and Labeling Standard for Diagnostic . Ultrasound Equipment Revision 1 (AIUM 1998)
- AIUM NEMA UD3 Standard for Real-time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
2
Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
JUL 1 4 2006
Mr. Randal Walker National Service Manager Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328
Re: K061641
Trade Name: EchoView/Shimasonic Diagnostic Ultrasound System - sarano Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: Dated: May 12, 2006 Received: June 13, 2006
Dear Mr. Walker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the sarano Diagnostic Ultrasound System, as described in your premarket notification:
3
Transducer Model Number
| L040-120HU | VA40R-035U | L072-050U |
|---|---|---|
| L040-100U | VA57R-0375WU | VA20R-035U |
| L070-075U | TV11R-055U | VA57R-0375U |
| VA11R-055U | EC11R-055U | |
| VA13R-035U | UB10R-065U |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This 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.
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.
4
Page 2 - Mr. Walker
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (301) 594-1212.
Sincerely yours,
David A. Legum
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
Ultrasound Device Indications Statement
Page _ 1 _ of __ 13
KOGI64 510(k) Number (if known) : Device Name : Diagnostic Ultrasound System sarano, system
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | นับบัง ประเทศเมน
Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Tissue
Harmonic
Imaging | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|--------------------------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | N | |
| Abdominal | | N | N | | | | | | N | N | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | N | N | | | | | | N | N | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | N | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | N | N | | | | | | N | N | |
| Transvaginal | | N | N | | | | | | N | N | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | | N | N | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | N | N | | | | | | N | N | |
| Musculo-skeletal
Superficial | | N | N | | | | | | N | N | |
| Other (Specify) | | | | | | | | | | | |
Mode of Oneration
N= new indication: P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
- Thyroid. Testicles. Breast ** В/М
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Degnan
11 Fridarrating 2
K06641
Prescription Use
6
Ultrasound Device Indications Statement
Page _2 _ of _ 14
K061641 510(k) Number (if known) : _
Device Name : Diagnostic Ultrasound System sarano. L040-120HU
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Tissue
Harmonic
Imaging | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | N | N | | | | | | N | N | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | | N | N | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | N | N | | | | | | N | N | |
| Musculo-skeletal
Superficial | | N | N | | | | | | N | N | |
| Others (Specify) | | | | | | | | | | | |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
- Thyroid. Testicles. Breast
** B/M
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE)
Daniel A. Lygonn
val.
Prescription Use
7
Ultrasound Device Indications Statement
Page _ 3 of _ 14
510(k) Number (if known): K061641.
Device Name: Diagnostic Ultrasound System sarano, L040-100U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Tissue
Harmoni
c
Imaging | Other
(Specify) |
|----------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-----------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative | | | | | | | | | | | |
| (Specify) | | | | | | | | | | | |
| Intra-operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | N | N | | | | | | N | N | |
| (Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | | N | N | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal | | N | N | | | | | | N | N | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal | | N | N | | | | | | N | N | |
| Superficial | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
| LA-AL-A-MILL-A-A-
STATE A-1-1-1-1-11-1
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11. 8. 1 9 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
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THE OWNER OF |
David Ch. Leggeem
Abdominal,
K061641
Prescription Else
8
Page ___ of Ultrasound Device Indications Statement
510(k) Number (if known): K061641
910(tr) Name : Diagnostic Ultrasound System sarano. L070-075U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Tissue
Harmonic
Imaging | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | N | N | | | | | | N | N | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | | N | N | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | N | N | | | | | | N | N | |
| Musculo-skeletal
Superficial | | N | N | | | | | | N | N | |
| Others (Specify) | | | | | | | | | | | |
Mode of Operation
14
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
- Thyroid, Testicles, Breast
** B/M
David h. Syomm
Abdominal
9
Ultrasound Device Indications Statement Page 5 of 14
510(k) Number (if known): K061641.
Device Name : Diagnostic Ultrasound stem sarano. VA11R-055U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Tissue
Harmonic
Imaging | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | N | |
| Abdominal | | N | N | | | | | | N | N | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | N | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |
Mode of Operation
N= new indication: P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
** B/M
David A. Lepore
Teproductive, Abdominal,
10
Ultrasound Device Indications Statement Page 6 of _14
510(k) Number (if known) : K061641
Device Name : Diagnostic Ultrasound VA13R-035U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Tissue
Harmonic
Imaging | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | N | |
| Abdominal | | N | N | | | | | | N | N | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | N | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
B/M
David A. Ingram
Reproductive, Abdon
| Labels | Values |
|---|---|
| ------------------------- | ------------------------- |
11
Ultrasound Device Indications Statement
Page _ 7 of _ 14
510(k) Number (if known): `