← Product Code [IYO](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO) · K992046
# SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM (K992046)
_Siemens Medical Solutions USA, Inc. · IYO · Aug 13, 1999 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO/K992046
## Device Facts
- **Applicant:** Siemens Medical Solutions USA, Inc.
- **Product Code:** [IYO](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO.md)
- **Decision Date:** Aug 13, 1999
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1560
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric
## Indications for Use
The SONOLINE 7XX 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 THI Imaging will not add new indications for use to the 7XX. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
## Device Story
SONOLINE 7XX is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via transducers and displays images in B-Mode, M-Mode, Color Mode, Pulsed (PW) Doppler, and Continuous (CW) Doppler on a CRT display. The device includes an on-screen display for thermal and mechanical indices. This submission adds Tissue Harmonic Imaging (THI) to the system, a feature previously cleared on the SONOLINE Elegra. The system is used by clinicians in various clinical settings to perform anatomical measurements and analysis for diagnostic purposes. Output is visualized by the healthcare provider to assist in clinical decision-making across multiple specialties.
## Clinical Evidence
No clinical data provided. Substantial equivalence is based on technological comparison and the fact that THI is already cleared on a predicate device.
## Technological Characteristics
Mobile diagnostic ultrasound system. Supports B-Mode, M-Mode, Color, PW Doppler, and CW Doppler. Includes THI imaging. Complies with UL 2601, CSA 22.2 No. 601-1, and IEC 601-1-1/1-2 safety standards. Displays thermal and mechanical indices per AIUM/NEMA 1992 standards.
## Regulatory 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.
## Special Controls
*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.
## Predicate Devices
- SONOLINE Versa Pro ([K945773](/device/K945773.md))
- SONOLINE Sienna ([K945773](/device/K945773.md))
- SONOLINE Elegra with THI Imaging ([K981528](/device/K981528.md))
## Submission Summary (Full Text)
> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).
{0}------------------------------------------------
# 510(K) SUMMARY
# Addition of Tissue Harmonic Imaging to SONOLINE 7XX 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.
- 1. Submitted By:
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: June 14, 1999
- 2. Proprietary Name: SONOLINE 7XX
Common/ Usual Name: Diagnostic Ultrasound System with Accessories
## Classification Name:
Ultrasonic Pulsed Doppler Imaging System (Product Code 90 IYN, 21 CFR 892.1550)
#### 3. Predicate Device:
K945773, 8/7/95, cleared as the Versa, marketed as the SONOLINE Versa Pro and SONOLINE Sienna SONOLINE Elegra with THI Imaging (K981528, cleared 10/29/98)
#### 4. Device Description:
The SONOLINE 7XX 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 ® 7XX, has been designed to meet the following product safety standards:
- 이 UL 2601, Safety Requirements for Medical Equipment
- 트 CSA 22.2 No. 601-1. Safety Requirements for Medical Equipment
- Standard for Real Time Display of Thermal and Mechanical Indices on Diagnostic I Ultrasound Equipment, AIUM/NEMA, 1992.
- 트 93/42/EEC Medical Devices Directive
- 트 EN60601 = (IEC 601-1-1 + IEC 601-1-2), Safety and EMC Requirements for Medical Equipment
#### 5. Intended Uses:
The SONOLINE 7XX ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial,
{1}------------------------------------------------
72040
(2)
OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications. The addition of THI Imaging will not add new indications for use to the 7XX.
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 7XX is a previously cleared device. The purpose of this submission is to receive clearance for the addition of THI to the already-cleared system. THI is already cleared on another Siemens system, the SONOLINE Elegra.
## End of 510(k) Summary
{2}------------------------------------------------
Public Health Service
1 3 1999 AUG
Steve Hesler Manager of Regulatory Affairs Siemens Medical Systems, Inc. 22010 S. E. 51st Street Issaquah, WA 98029-7002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
K992046 Re:
.
SONOLINE 7XX Diagnostic Ultrasound System (Addition of Harmonic Imaging Option) Dated: June 14, 1999 Received: June 17, 1999 Regulatory Class: II 21 CFR 892.1550/Procode: 90 IYN 21 CFR 892.1560 / Procode: 90 IYO
Dear Mr. Hesler:
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 SONOLINE 7XX Diagnostic Ultrasound System, as described in your premarket notification:
#### Transducer Model Number(s)
2.5 P20 3.5 C40+ 5.0 L45
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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.
{3}------------------------------------------------
Page -2 - Mr. Hesler
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 REVIEWER at (301) 594-1212.
Sincerely yours,
Vivid G. Lymm
CAPT Daniel Schulte, M.D.
CAPT Daniel Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
## Attachment 3
## Ultrasound Device Indications Statement
Note: Indications for use are unchanged from what was originally submitted to FDA for both the Versa Pro and the Versa Plus. The table below represents a compilation of all applications for all transducers cleared for use with the Versa family of products. The Versa family currently includes the SONOLINE Sienna and the SONOLINE Versa Plus.
510 (k) Number (if known) K962142 (May 29, 1997), K9945773 (August 7, 1995)
- Device Name : SONOLINE Versa Family of Diagnostic Ultrasound Systems
- Indications For Use: Diagnostic ultrasound imaging and Doppler analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Tissue
Harmonic
Imaging | |
|-------------------------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-------------------------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC (P) | N | |
| Abdominal | | P | P | P | P | P | P | | BMDC (P) | N | |
| Intraoperative
Abdominal | | P | P | P | | | P | P | | BMDC (P) | |
| Neurosurgical | | P | P | P | | P | P | | BMDC (P) | | |
| Pediatric | | P | P | P | P | P | P | | BMDC (P) | N | |
| Small Organ
(Specify) | | P | P | P | P | P | P | | BMDC (P) | N | |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC (P) | N | |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC (P) | N | |
| Cardiac | | P | P | P | P | P | P | | BMDC (P) | N | |
| Transesophageal | | P | P | P | | P | P | | BMDC (P) | | |
| Transrectal | | P | P | P | | P | P | | BMDC (P) | | |
| Transvaginal | | P | P | P | | P | P | | BMDC (P) | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC (P) | N | |
| Laparoscopic | | P | P | P | | P | P | | BMDC (P) | | |
| Musculo-skeletal
Conventional | | P | P | P | P | P | P | | BMDC (P) | N | |
| Musculo-skeletal
Superficial | | P | P | P | P | P | P | | BMDC (P) | | |
| Other (specify) | | | | | | | | | | | |
| N = new indication; P = previously cleared by FDA; E = added under Appendix E | | | | | | | | | | | |
(Applications which do not apply are heavily shaded)
N = new indication; Other Indications or Modes: _ E = added under Appendix E
***_*** and**_**, and I am unable to answer the question.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Prescription Use (Per 21 CFR 801.109)
Jamil Ch. Seapom
n Sign-Off) Division of Reproductive, Abdomina and Radiological I
vplsthi510kb.doc
) Number K992046
1
{5}------------------------------------------------
K962142 (May 29, 1997) 510 (k) Number (if known) 2.5P20 transducer for use with SONOLINE 7XX Device Name : Diagnostic ultrasound imaging and Doppler analysis Indications For Use: of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Tissue
Harmonic
Imaging | |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-------------------------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | E | E | E | E | E | E | | BMDC (E) | N | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC (P) | N | |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC (P) | N | |
| Cardiac | | P | P | P | P | P | P | | BMDC (P) | N | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
# (Applications which do not apply are heavily shaded)
N = new indication;
E = added under Appendix E
- Other Indications or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CFR 801.109)
P = previously cleared by FDA;
Emil h. Sypman
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devi 510(k) Number
{6}------------------------------------------------
# 510 (k) Number (if known)
K962142 (May 29, 1997)
Device Name :
Indications For Use:
3.5C40+ transducer for use with SONOLINE 7XX
Diagnostic ultrasound imaging and Doppler analysis of the human body as follows:
| Clinical
Application | ಗ | 3 | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Tissue
Harmonic
Imaging |
|----------------------------------|----------|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ophthalmic | 1 Cati | 1995 - 1 | 1356 | 1477 27933 | | A BART AND A BEACH | 143 × 62 × 6 × 2 × 3 × 5 × 5 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × 3 × | 991 1220 1 | 2019 - 10:40 PM #11 - 1 | ARENTAMENTAR |
| Fetal | | P | P | P | 0 | P | p | ASSESS OF ASSESS OF | BMDC (P) | N |
| Abdominal | | 0 | p | P | P | P | P | 36 2017 13 499 | BMDC (P) | N |
| Intraoperative
Abdominal | | | | | ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ | | | ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ | | |
| Neurosurgical | | | | | 1999 1999 | | | of the comments of | | |
| Pediatric | | p | P | p | P | P | P | Portugues of | BMDC (P) | ਮ |
| Small Organ
(Specify) | | | | | | | | ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ | | |
| Neonatal Cephalic | | | | | | | | 2017 12:00:50 | | |
| Adult Cephalic | | | | | | | | のおりしくなって | | |
| Cardiac | | | | | | | | のおり、おすす | | |
| Transesophageal | | | | | | | | Antaliana Andressa ( | | |
| Transrectal | | | | | 123233 | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | ្រទេស រុ | | 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | 1 24 | 1999 - 1991 | | 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 | 2017 2017 19:41 | ARTICLE A | |
| intravascular | : 大 | 12 1075 | 1991 - 199 | 2 : 2017 : 2 | 出版社 | Bearing and a | 1991 31 114 114 | 10 - 12 - 2 - 2 - 2 - 2 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 3 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - | 11 10 10 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 1 | 家 - 大 - 大 - 大 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 - 人 |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | And States of the States | | |
| Musculo-skeletal
Conventional | | | | | | | | 2017-02-01 | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | 发大发展的新闻 | | 2006 000 000 |
## (Applications which do not apply are heavily shaded)
N = new Indication;
P = previously cleared by FDA;
E = added under Appendix E
Other Indications or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED).
Prescription Use (Per 21 CFR 801.109)
Eurid le. Seppon
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological I 510(k) Number
{7}------------------------------------------------
| 510 (k) Number (if known) | K962142 (May 29, 1997) |
|---------------------------|----------------------------------------------------------------------------------|
| Device Name : | 5.0L45 transducer for use with SONOLINE 7XX |
| Indications For Use: | Diagnostic ultrasound imaging and Doppler analysis of the human body as follows: |
# (Applications which do not apply are heavily shaded)
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Tissue
Harmonic
Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | P | P | P | P | P | P | | BMDC (P) | N |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC (P) | N |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | P | P | P | | BMDC (P) | N |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication;
E = added under Appendix E P = previously cleared by FDA;
Other Indications or Modes: __________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CFR 801.109)
David L. Sigmon
(Division Sign-Off) 0 Division of Reproductive, Abdominal, E and Radiological Device 510(k) Number
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO/K992046](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO/K992046)
**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).
**Cite:** Innolitics at https://innolitics.com