← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K182932
# RS85 Diagnostic Ultrasound System (K182932)
_Samsung Medison Co., Ltd. · IYN · Feb 15, 2019 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K182932
## Device Facts
- **Applicant:** Samsung Medison Co., Ltd.
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** Feb 15, 2019
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric
## Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.
## Device Story
RS85 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers (linear, curved, phased, endocavity, static) and displays images in 2D, Color Doppler, Power Doppler (S-Flow), PW/CW Spectral Doppler, Harmonic imaging, Tissue Doppler, 3D/4D, and Elastoscan modes. Used in clinical settings by healthcare professionals to visualize anatomical structures and analyze body fluids. The system provides real-time acoustic output (mechanical/thermal indices) and includes analysis packages for measurements. Operators use the system to aid in diagnosis. Benefits include non-invasive diagnostic imaging and guidance for procedures like biopsies.
## Clinical Evidence
No clinical studies were required to support substantial equivalence. Evidence is based on bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection validation, and electrical/electromagnetic safety testing per IEC/ISO standards.
## Technological Characteristics
Mobile cart-based system with 192 transmit/receive channels. Transducer frequencies: 1.0–20.0 MHz. Features LCD monitor (LED backlight), 256 gray shades, and 100-240VAC power. Connectivity includes WLAN. Software-driven imaging modes: B, M, PW/CW Doppler, Color Doppler, 3D/4D, Elastoscan, S-Fusion, S-Shearwave, and S-Detect. Biocompatibility per ISO 10993-1. Electrical safety per ANSI AAMI ES60601-1. EMC per IEC 60601-1-2.
## Regulatory Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
## Predicate Devices
- RS85 Diagnostic Ultrasound System ([K173204](/device/K173204.md))
## Reference Devices
- LOGIQ E9 Diagnostic Ultrasound System ([K142160](/device/K142160.md))
- Aplio i900/i800/i700/i600 Diagnostic Ultrasound System ([K182679](/device/K182679.md))
## Submission Summary (Full Text)
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February 15, 2019
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SAMSUNG MEDISON CO., LTD. % Ji Yea Lee Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA
Re: K182932
Trade/Device Name: RS85 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 11, 2019 Received: January 15, 2019
Dear Ji Yea Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K182932
Device Name RS85 Diagnostic Ultrasound System
Indications for Use (Describe)
The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluid. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) No.:
Device Name: RS85 Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|-------------------------------------------|--|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 3, 4, 7, 8, 9, 11, 14 | |
| | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 4, 5, 6, 7, 8, 9, 11, 12, 14, 15 | |
| | Intra-operative (See Note 6) | P | P | P | | P | Note 1 | Note 7, 9, 11 | |
| | Intra-operative (Neuro.) | P | P | P | | P | Note 1 | Note 7, 9, 11 | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 | |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12, 14 | |
| | Neonatal Cephalic | P | P | P | | P | Note 1 | Notes 8, 9, 11 | |
| | Adult Cephalic | P | P | P | P | P | Note 1 | Notes 7 | |
| | Trans-rectal | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11, 12 | |
| | Trans-vaginal | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11, 12 | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | |
| | Intra-luminal | | | | | | | | |
| | Other (See Note 13) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 12 | |
| | Cardiac Adult | P | P | P | P | P | Note 1 | Notes 4, 7 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Notes 4, 7 | |
| | Trans-esophageal (Cardiac) | P | P | P | P | P | Note 1 | Notes 4, 7 | |
| | Other (spec.) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | |
| | Other (spec.) | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
{4}------------------------------------------------
510(k) No.:
### Device Name: CA1-7A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|--------------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2,4,7,8,9,11,14 |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 2,6,7,8,9,11,14,15 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 2,6,7,8,9,11,14 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Notes 2,6,7,8,9,11,14 |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | P | P | P | | P | Note 1 | Notes 2,6,7,8,9,11,14 |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Notes 2,6,7,8,9,11,14 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPL, B+CW, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion Note 15: S-Shearwave
{5}------------------------------------------------
510(k) No.:
### Device Name: CF4-9 for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | | | | | | | |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 7, 8, 9, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 7, 8, 9, 11 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | Note 1 | Notes 7, 8, 9, 11 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Notes 8, 9, 11 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion Note 15: S-Shearwave
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510(k) No.:
### Device Name: CA2-8A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-------------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+DPI, B+CW, B+C+PW, B+PD+PW, B+PPF+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
- Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
- Note 6: Abdominal organs and peripheral vessel
- Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
- Note 9: MultiVision (Spatial Compound Imaging)
- Note 10: Includes Renal, Gynecology/Pelvis
- Note 11: Panoramic imaging
- Note 12: ElastoScan
- Note 13: Includes Urology/Prostate
- Note 14: S-Fusion Note 15: S-Shearwave
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510(k) No.:
### Device Name: CA3-10A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-------------------------|--|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 3, 7, 8, 9, 11 | |
| | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 | |
| | Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 | |
| | Intra-luminal | | | | | | | | |
| | Other (See Note 13) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| | | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 | |
| | Other (spec.) | | | | | | | | |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CV, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
- Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
- Note 10: Includes Renal, Gynecology/Pelvis
- Note 11: Panoramic imaging
- Note 12: ElastoScan
- Note 13: Includes Urology/Prostate Note 14: S-Fusion
Note 15: S-Shearwave
{8}------------------------------------------------
510(k) No.:
### Device Name: E3-12A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|----------------------|--|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | |
| | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | |
| | Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (See Note 13) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion Note 15: S-Shearwave
{9}------------------------------------------------
510(k) No.:
### Device Name: L3-12A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-----------------------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | | | | | | | |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12, 14 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPL, B+CW, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion Note 15: S-Shearwave
{10}------------------------------------------------
### 510(k) No.:
Device Name: EA2-11B for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9 |
| | Abdominal (See Note 12) | P | P | P | P | P | Note 1 | Note 2, 6, 7, 8, 9, 12 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 |
| | Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPH+W, B+PPH+PW, B+ID+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
- Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
- Note 9: MultiVision (Spatial Compound Imaging)
- Note 10: Includes Renal, Gynecology/Pelvis
- Note 11: Panoramic imaging
- Note 12: ElastoScan
- Note 13: Includes Urology/Prostate
- Note 14: S-Fusion
- Note 15: S-Shearwave
{11}------------------------------------------------
510(k) No.:
### Device Name: LA2-9A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|---------------------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | | | | | | | |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11,12,15 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11,12,15 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11,12,15 |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion Note 15: S-Shearwave
{12}------------------------------------------------
510(k) No.:
### Device Name: LA3-16A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | |
|-----------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|----------------------------|
| General | Specific | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
| (Track I only) | (Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | | | | | | | |
| | Abdominal (See Note 10) | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging
&
Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11, 12 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CV, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
- Note 6: Abdominal organs and peripheral vessel
- Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
- Note 9: MultiVision (Spatial Compound Imaging)
- Note 10: Includes Renal, Gynecology/Pelvis
- Note 11: Panoramic imaging
- Note 12: ElastoScan
- Note 13: Includes Urology/Prostate
- Note 14: S-Fusion Note 15: S-Shearwave
{13}------------------------------------------------
510(k) No.:
### Device Name: LA3-16AI for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
& Other | Fetal/Obstetrics (See Note 3) | | | | | | | |
| | Abdominal (See Note 10) | | | | | | | |
| | Intra-operative (See Note 6) | P | P | P | | P | Note 1 | Note 7, 9, 11 |
| | Intra-operative (Neuro.) | P | P | P | | P | Note 1 | Note 7, 9, 11 |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 7, 9, 11 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 7, 9, 11 |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 7, 9, 11 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CV, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
- Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
- Note 9: MultiVision (Spatial Compound Imaging)
- Note 10: Includes Renal, Gynecology/Pelvis
- Note 11: Panoramic imaging
- Note 12: ElastoScan
- Note 13: Includes Urology/Prostate Note 14: S-Fusion
- Note 15: S-Shearwave
{14}------------------------------------------------
510(k) No.:
### Device Name: LA4-18B for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|--|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-----------------------------------|
| General
(Track I only) | Specific
(Tracks I & III) | | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | |…
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K182932](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K182932)
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