ALOKA LISENDO 880
Device Facts
| Record ID | K162583 |
|---|---|
| Device Name | ALOKA LISENDO 880 |
| Applicant | Hitachi , Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Nov 17, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
ALOKA LISENDO 880 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Spec.), Intra-operative (Spec.), Neonatal Cephalic, Musculo-skel. (Convent./Superfic.), Peripheral vessel, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card), Adult Cephalic clinical applications. The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.
Device Story
The ALOKA LISENDO 880 is a diagnostic ultrasound system used by clinicians (doctors, sonographers) in clinical settings. It utilizes ultrasound transducers to transmit energy into the body and detect reflected echoes. A computer system processes these signals to generate images or Doppler data, which are displayed on a video monitor. The device supports multiple modes, including B-mode, M-mode, Pulsed/Continuous Wave Doppler, Color/Power Doppler, Tissue Doppler Imaging, and 3D/4D imaging. Clinicians use the output to perform diagnostic evaluations and fluid flow analysis. The system aids in clinical decision-making by providing real-time visualization of internal structures and hemodynamics, facilitating procedures such as biopsies and general diagnostic assessments.
Clinical Evidence
No clinical data was required or provided. Substantial equivalence is supported by bench testing, including acoustic output measurements, biocompatibility, electromagnetic compatibility, and electrical/mechanical safety testing in accordance with applicable standards.
Technological Characteristics
Diagnostic ultrasound system with convex, linear, and sector transducers. Features include B, M, PW, CW, Color/Power Doppler, TDI, and 3D/4D imaging. Connectivity includes DICOM (SR, QR). Biocompatibility per ISO 10993-1. System is designed for re-usable probes with defined cleaning/disinfection protocols. Operates under Track 3 FDA limits.
Indications for Use
Indicated for diagnostic ultrasound evaluation of fetal, abdominal, pediatric, small organ, intra-operative, neonatal cephalic, musculoskeletal, peripheral vessel, cardiac (adult/pediatric), trans-esophageal, and adult cephalic applications in adult and pediatric patients.
Regulatory Classification
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
- ARIETTA 70 (K134016)
Related Devices
- K134016 — ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER · Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · Mar 28, 2014
- K060059 — ALOKA SD-3500 ULTRASOUND SYSTEM · Aloka Co., Ltd. · Jan 13, 2006
- K040719 — ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY · Aloka Co., Ltd. · Mar 26, 2004
- K111227 — ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM · Aloka Co., Ltd. · May 13, 2011
- K173739 — ALOKA ARIETTA 850 · Hitachi Healthcare Americas Corporation · Feb 28, 2018
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2016
Hitachi, Ltd. % Ms. Angela Van Arsdale RA/QA Manager Hitachi Aloka Medical America, Inc. 10 Fairfield Boulevard WALLINGFORD CT 06492-5903
Re: K162583
Trade/Device Name: ALOKA LISENDO 880 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 29, 2016 Received: September 30, 2016
Dear Ms. Van Arsdale:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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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## Indications for Use
510(k) Number (if known) K162583
Device Name ALOKA LISENDO 880
### Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
ALOKA LISENDO 880 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Spec.), Intra-operative (Spec.), Neonatal Cephalic, Musculo-skel. (Convent./Superfic.), Peripheral vessel, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card), Adult Cephalic clinical applications.
The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
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{3}------------------------------------------------
#### Device Name: ALOKA LISENDO 880
| Clinical Application | | | | Mode of Operation | | | | |
|---------------------------|------------------------------------|----|----|-------------------|-----|------------------|-------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | P | P | P | P |
| Fetal Imaging<br>& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | Pb |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd |
| | Neonatal Cephalic | P | P | P | P | P | P | P |
| | Adult Cephalic | P | P | P | P | P | P | P |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | Pg | Pg | Pg | Pg | Pg | Pg | Pg |
| | Musculo-skel. (Convent.) | P | P | P | P | P | P | P |
| | Musculo-skel. (Superfic.) | P | P | P | P | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| | Trans-esophageal (Adult/Pediatric) | Pg | Pg | Pg | Pg | Pg | Pg | Pg |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | P | P | P |
| Vessel | Other (spec.) | | | | | | | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
|--------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------|
N = new indication; P = previously cleared in K134016, K142368
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography). Tissue Doppler Imaging, Free Angular M-mode, 3D Imaging
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Includes imaging for guidance of trans-vaginal biopsy. Subscript "f":
Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 2 of 17
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## Device Name: ALOKA LISENDO 880 Transducer: C251 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|--|-------------------|----|-----|-----|------------------|-------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | P | P | P | P | P | P | P |
| Fetal Imaging<br>& Other | Abdominal | | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | | Pd | Pd | Pd | Pd | Pd | Pd | Pd |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (Wound) | | | | | | | | |
| | Other (Gynecological) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |
N = new indication; P = previously cleared in K134016
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 3 of 17
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## Device Name: ALOKA LISENDO 880 Transducer: C252 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|----|----|-----|-----|------------------|--------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe) | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | P | P | P | P |
| Fetal Imaging<br>& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K134016
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 4 of 17
{6}------------------------------------------------
## Device Name: ALOKA LISENDO 880 Transducer: C35 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|----|-----|-----|------------------|-------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | P | P | P | P |
| Fetal Imaging<br>& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K134016
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 5 of 17
{7}------------------------------------------------
## Device Name: ALOKA LISENDO 880 Transducer: C42K Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation B M PWD CWD Color Other** General Specific Combined* (Track I only) (Tracks I & III) Doppler (Spe (Spec.) Ophthalmic Ophthalmic Fetal Fetal Imaging Abdominal & Other Intra-operative (Spec.) Pb Pb Pb Pb Pb Pb Intra-operative (Neuro.) Laparoscopic Pediatric Small Organ (Spec.) Pd Pd Pd Pd Pd Pd Neonatal Cephalic P P P P P P Adult Cenhalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Intra-luminal Other (Wound) Other (Gynecological) Cardiac Adult Cardiac Cardiac Pediatric Trans-esophageal (Adult/Pediatric) Other (spec.) Peripheral vessel Peripheral Vessel Other (spec.) N = new indication; P = previously cleared in K134016
* Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Free Angular M-mode
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Includes imaging for guidance of trans-rectal biopsy Subscript "e":
Includes imaging for guidance of trans-vaginal biopsy. Subscript "f":
Subscript "g": For Adult and pediatric patients
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 6 of 17
{8}------------------------------------------------
## Device Name: ALOKA LISENDO 880 Transducer: L34 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|----|-----|-----|------------------|----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spec.) | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging<br>& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | P | P | P | P |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | P |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K134016
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Includes imaging of organs and structures exposed during surgery and laparoscopic procedures). Subscript "b":
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 7 of 17
{9}------------------------------------------------
## Device Name: ALOKA LISENDO 880 Transducer: L441 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | | Mode of Operation | | | | |
|---------------------------|------------------------------------|----|----|-------------------|-----|------------------|-------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging<br>& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | P | P | P | P |
| | Musculo-skel. (Superfic.) | P | P | P | P | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | P |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K134016, K142368
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery
- (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
- Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Includes imaging for guidance of trans-vaginal biopsy. Subscript "f":
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 8 of 17
{10}------------------------------------------------
# Device Name: ALOKA LISENDO 880 Transducer: L64
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation B M PWD CWD Color Other** General Specific Combined* (Track I only) (Tracks I & III) Doppler (Spe (Spec.) Ophthalmic Ophthalmic Fetal Fetal Imaging Abdominal Pa Pa Pa Pa Pa Pa Pa & Other Intra-operative (Spec.) Intra-operative (Neuro.) Laparoscopic Pediatric P P P P P P P Small Organ (Spec.) Pd Pd Pd Pd Pd Pd Pd Neonatal Cephalic Adult Cenhalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) P P P P P P P P Musculo-skel. (Superfic.) P P P P P P Intra-luminal Other (Wound) Other (Gynecological) Cardiac Adult Cardiac Cardiac Pediatric Trans-esophageal (Adult/Pediatric) Other (spec.) Peripheral vessel P P P P P P P Peripheral Vessel Other (spec.)
N = new indication; P = previously cleared in K134016, K142368
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Free Angular M-mode
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures)
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Includes imaging for guidance of trans-rectal biopsy Subscript "e":
Includes imaging for guidance of trans-vaginal biopsy. Subscript "f":
Subscript "g": For Adult and pediatric patients
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 9 of 17
{11}------------------------------------------------
## Device Name: ALOKA LISENDO 880 Transducer: MXS1 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|----------------------|--------------------|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spec.) | Other**<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | P | P | P | P | |
| Fetal Imaging<br>& Other | Abdominal | P | P | P | P | P | P | P | |
| | Intra-operative (Spec.) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | |
| | Small Organ (Spec.) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | P | P | P | P | P | P | P | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (Wound) | | | | | | | | |
| | Other (Gynecological) | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | |
| | Cardiac Pediatric | P | P | P | P | P | P | P | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | P | |
| | Other (spec.) | | | | | | | | |
N = new indication; P = previously cleared in K134016
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Dopler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode, 3D Imaging
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures)
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 10 of 17
{12}------------------------------------------------
#### Device Name: ALOKA LISENDO 880 Transducer: MXS2ESLL Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
intended use. Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows.
| | Clinical Application | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|----|-----|-----|------------------|-------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging | Abdominal | | | | | | | |
| & Other | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | Pg | Pg | Pg | Pg | Pg | Pg | Pg |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | Pg | Pg | Pg | Pg | Pg | Pg | Pg |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K134016, K142368
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Dopler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode, 3D Imaging
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript g. For Adult and pediatric patients.
Subscript “h.” Includes imaging for Cavernous/Naso
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 11 of 17
{13}------------------------------------------------
## Device Name: ALOKA LISENDO 880 Transducer: S121 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | P | P | P | P |
| Fetal Imaging | Abdominal | P | P | P | P | P | P | P |
| & Other | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | P | P | P | P | P | P | P |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | P | P | P |
| Vessel | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K134016
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 12 of 17
{14}------------------------------------------------
## Device Name: ALOKA LISENDO 880 Transducer: S31 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
intended use. Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation |
|----------------------|-------------------|
|----------------------|-------------------|
| | Clinical Application<br>Mode of Operation | | | | | | | |
|---------------------------|-------------------------------------------|---|---|-----|-----|------------------|-------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging<br>& Other | Abdominal | P | P | P | P | P | P | P |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | P | P |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K134016
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 13 of 17
{15}------------------------------------------------
## Device Name: ALOKA LISENDO 880 Transducer: S3ESEL Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Intended use. Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows.
| Clinical Application | | | Mode of Operation | | | | | |
|---------------------------|------------------------------------|----|-------------------|-----|-----|------------------|-------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging<br>& Other | Abdominal | | | | | | | |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | Pg | Pg | Pg | Pg | Pg | Pg | Pg |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | Pg | Pg | Pg | Pg | Pg | Pg | Pg |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K134016, K142368
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures)
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 14 of 17
{16}------------------------------------------------
## Device Name: ALOKA LISENDO 880 Transducer: S42 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging<br>& Other | Abdominal | P | P | P | P | P | P | P |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P…
