← Product Code [IYN](/productcode/IYN) · K040409 # LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM (K040409) _Larsen & Toubro Limited · IYN · Feb 27, 2004 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K040409 ## Device Facts - **Applicant:** Larsen & Toubro Limited - **Product Code:** [IYN](/productcode/IYN.md) - **Decision Date:** Feb 27, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1550 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Pediatric, 3rd-Party Reviewed ## Indications for Use The Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. ## Device Story The SENORITA Colour Doppler Ultrasound System is a diagnostic imaging device used in clinical settings by healthcare professionals. It utilizes ultrasound transducers (linear and curved linear arrays) to transmit acoustic pulses into the human body and receive echoes. The system processes these signals to generate B-mode, M-mode, Pulsed Wave (PW) Doppler, and Color Doppler images. It features multi-frequency support, transmit/receive focusing, and image processing tools like edge enhancement, tissue discrimination, and flash suppression. The system is operated via a keyboard console and 15-inch SVGA monitor. Output is displayed as real-time images or fluid flow analysis, assisting clinicians in diagnosing conditions across various anatomical regions. The device benefits patients by providing non-invasive visualization of internal structures and blood flow, supporting clinical decision-making. ## Clinical Evidence Bench testing only. The submission relies on technical specifications, acoustic output measurements, and performance comparisons to predicate devices. No clinical studies were required or provided to establish substantial equivalence. ## Technological Characteristics System is a Class I, Type BF/CF device. Features 15" SVGA monitor, Windows 2000 OS, and two ITT Cannon DL 156 probe connectors. Supports linear and curved linear arrays (up to 128 elements). Imaging modes: B, M, PW, Color, Power Doppler. Connectivity includes RJ45 (LAN), USB, and VGA. Safety compliance per IEC 60601. Acoustic power control and 8-level TGC. Image processing includes focus, dynamic range, persistence, and edge enhancement. ## 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 - TETRAD 2300 E/U Ultrasound Imaging System with Color Flow Doppler Imaging ([K946277](/device/K946277.md)) - Acuson Aspen System ([K991805](/device/K991805.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}------------------------------------------------ K04 0409 FEB 27 2004 # 510(k) Summary for Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System - 1. SPONSOR Larsen & Toubro Limited Medical Equipment & Systems SBU KIADB Industrial Area Hebbal, Hootagalli Mysore - 570018 Karnataka, INDIA | Contact Person: | Mr. A. B. Deshpande | |-----------------|---------------------------------------------| | | Head - Quality Assurance & Customer Support | | | Medical Equipment & Systems | | | Larsen & Toubro Limited | | Phone: | 011-91-821-402561 | | Fax: | 011-91-821-2402468 | | E-mail: | DeshpandeAB@myw.ltindia.com | - Date Prepared: November 20, 2003 #### 2. DEVICE NAME | Proprietary Name: | Larsen & Toubro Limited SENORITA Colour
Doppler Ultrasound System | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common/Usual Name: | Ultrasound System and Transducers | | Classification Name: | Ultrasonic Pulsed Doppler Imaging System
(21 CFR 892.1550, 90 ΙΥΝ)
Ultrasonic Pulsed Echo Imaging System
(21 CFR 892.1560, 90 IYO)
Diagnostic Ultrasound Transducer
(21 CFR 892.1570, 90-ITX) | #### 3. PREDICATE DEVICES TETRAD 2300 E/U Ultrasound Imaging System with Color Flow Doppler Imaging (K946277), and Acuson Aspen System (K991805). - INTENDED USE 4. The Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis {1}------------------------------------------------ of the human body; specific indications for use a tabulated in Section 4.3 of this submission. ### Device Description 5. Technical specifications for the Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System are as follows: # System Specifications | Type of protection against
electric shocks | Class I | |-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Degree of protection against
electric shock
for ultrasound probes
For ECG electrodes | Type "BF"
Type 'CF" | | Degree of protection against
hazard of explosion | Not protected | | Degree of protections against
ingress of liquids | IPXO | | Power Requirements
AC input | 110 V AC
60 Hz single phase | | Fuse | Two (2) 12A, slow blow, glass cartridge fuses
in Line and Neutral | | Load | Total: 1000A
(System: 850 VA,
Aux. Output: 150 VA) | | Leakage | <145μA as per UL2601 | | General Specifications | | | Dimensions | 1400mm(H) x 620mm(W) x 800mm(D) | | Weight | 120kg/270 lbs. (approximate) | | Keyboard console rotation
Rotation of console
Monitor tilt | Keyboard +/- 30°
+/-30 | | External Ports | FDD
CDRW
Parallel port-inkjet printer
USB port (rear panel) Laser printer
RJ45 (LAN) port - Networking
VGA port-SVGA monitor (slave)
DIN Port-Footswitch
Audio Port (real panel) Relay out
Audio port (front panel) Headphone
USB port (front panel) Thumb Drive
Auxiliary power - additional Monitor | | Monitor | 15" SVGA monitor | | Size of image | 512 x 512 pixels | | Operating temperature | 10°C to 35°C | | Humidity | 80% RH | | Safety | The product shall comply to the Safety
Standards as per IEC 60601 | | Language | English | | Technical Specifications | | | Operating System | Windows 2000 | | Probe Connectors | Two (2) ITT Cannon DL 156 connectors | | Options | Colour Doppler
PW Spectral Doppler | | Gain | Overall gain controls for B & M modes
(combined)
D mode (Pulsed Doppler)
C mode (Colour Doppler)
P mode (Power/amplitude Doppler) | | Power | Acoustic power control | | TGC | Eight (8) slide switches for eight (8) depths | | Image Processing
General | Focus
Multifocus
Dynamic Range
Sensitivity
Persistence | {2}------------------------------------------------ {3}------------------------------------------------ | Pre-processing
M mode speed
D mode speed
Image Memory Size
Grey Scale | Temporal averaging
Tissue discrimination
Colour maps
Thresholding
Flash Suppression
Edge Enhancement
2s, 4s, and 8s
2s, 4s, and 8s
512 x 512 x 8 bits
256 levels | | | |-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-------------------------------------------| | Image Specifications | | | | | Array types | Linear
Curved Linear | | | | Maximum array size | 128 elements | | | | Maximum symmetric aperture | 48 elements | | | | Scan conversion | PCI card color
(8 bit grayscale output with 256 shades) | | | | Display | 24 bit color
Selectable gray maps | | | | Imaging resolution | (Best case, measured in water, assuming f/2
for lateral resolution measurement)
Freq.
3 MHz
5 MHz
7.5 MHz | Axial
1 mm
0.65 mm
0.41 | Lateral
1.025 mm
0.75 mm
0.49 mm | | Magnification | Magnification factors: 1.5, 1.8, 2.0 real time
images | | | | Image orientation | Horizontal (left/right) and
Vertical (up/down) inversion of image | | | | Probes supported | Standard Abdominal
Endovaginal
Tightly curved Cardiovascular
Vascular | | | | Multi-Frequency | Supported on all probes | | | | Center Frequency | 3.0 -12.0 MHz (20 MHz upper band edge) | | | {4}------------------------------------------------ | Transmit Focus | Multi-zones, 1 to 8 zones, interleaved | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Received focus methods | Dynamic
Updated every 1.5 mm in depth
Errors ≤ 10° in the 3 to 12 MHz range
Envelope delays switched between transmit
zones
Transmit focus increment - 10 ns
Transmit waveform - bipolar burst
150 V p-p max | ### б. BASIS FOR SUBSTANTIAL EQUIVALENCE The Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System is substantially equivalent to the TETRAD 2300 E/U Ultrasound Imaging System with Color Flow Doppler Imaging, and to the Acuson Aspen System. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 resembling an eagle or bird with three stylized wing-like shapes. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Larsen & Toubro Limited % Mr. Juergen Welte 510(k) Program Manager TUV Rheinland of North America 1279 Quarry Lane, Suite A PLEASANTON CA 94566 Re: K040409 Trade Name: Senorita Colour Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regualtion Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and IYX Dated: January 26, 2004 Received: February 18, 2004 ## Dear Mr. Welte: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. FEB 27 2004 This determination of substantial equivalence applies to the following transducers intended for use with the Senorita Colour Doppler Ultrasound System, as described in your premarket notification: Transducer Model Number TC-101-CP (2.5 - 5.0 MHz Curved Linear Array Transducer) TC-110-CP (2.5 - 4.5 MHz Curved Linear Transducer) TC-200-LP (6 - 9 MHz Linear Transducer) {6}------------------------------------------------ ## TC-201-LP (5 - 8 MHz Linear Transducer) TC-400-EP (Curved Linear 5 - 9 MHz Transvaginal Transducer) If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded. The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to: > Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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", {7}------------------------------------------------ If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212. Sincerely yours, Nancy C. bogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosures {8}------------------------------------------------ System: Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System | Clinical Application | Mode of Operation | | | | | | | | |---------------------------|------------------------------------------------|---|----|------|-----|-------------------|--------------------|-------| | General
(Track I Only) | Specific
(Tracks I & III) | B | Ma | PWDb | CWD | Color
Dopplerc | Combined
Modesd | Other | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal | N | N | N | | N | N | | | | Abdominal | N | N | N | | N | N | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | Fetal Imaging
& Other | Pediatric | N | N | N | | N | N | | | | Small Organ (Thyroid,
Breast, Testes, etc.) | N | N | N | | N | N | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | N | N | N | | N | N | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel.
(Conventional) | N | N | N | | N | N | | | | Musculo-skel. (Superficial) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac Adult | N | N | N | | N | N | | | Cardiac | Cardiac Pediatric | N | N | N | | N | N | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral
Vessel | Peripheral vessel | N | N | N | | N | N | | | | Other (Specify) | | | | | | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: N: subject of this submission. ª Includes B+M. ് Includes B+PWD. E Includes Color Doppler (CD) ; Amplitude Doppler (AD); B+CD; B+AD. 4B+PWD+CD; B+PWD+AD (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109) Nancy C. Baughon (Division Sign Division of Renre and Radiological Dev 510(k) Number {9}------------------------------------------------ | Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System | | | | | | | | | |--------------------------------------------------------------------------------------------------|------------------------------------------------|-------------------|----|------|-----|-------------------|--------------------|-------| | Transducer: TC-101-CP (2.5 - 5.0 MHz Curved Linear Transducer) | | | | | | | | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | Clinical Application | | Mode of Operation | | | | | | | | General
(Track I Only) | Specific
(Tracks I & III) | B | Ma | PWDb | CWD | Color
Dopplerc | Combined
Modesd | Other | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal | N | N | N | | N | N | | | | Abdominal | N | N | N | | N | N | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | Fetal Imaging
& Other | Pediatric | N | N | N | | N | N | | | | Small Organ (Thyroid,
Breast, Testes, etc.) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel.
(Conventional) | | | | | | | | | | Musculo-skel. (Superficial) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral
Vessel | Peripheral vessel | | | | | | | | | | Other (Specify) | | | | | | | | N: subject of this submission. ª Includes B+M. b Includes B+PWD. 9 Includes Color Doppler (CD) ; Amplitude Doppler (AD); B+CD; B+AD. ªB+PWD+CD; B+PWD+AD (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devi 510(k) Number ________________________________________________________________________________________________________________________________________________________________ {10}------------------------------------------------ | System: _______ Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System _______ | | | | | | | | | |--------------------------------------------------------------------------------------------------|------------------------------------------------|-------------------|---|-----|-----|------------------|-------------------|-------| | Transducer: _______ TC-110-CP (2.5 - 4.5 MHz Curved Linear Transducer) | | | | | | | | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | Clinical Application | | Mode of Operation | | | | | | | | General
(Track I Only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined
Modes | Other | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging
& Other | Fetal | | | | | | | | | | Abdominal | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (Thyroid,
Breast, Testes, etc.) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel.
(Conventional) | | | | | | | | | | Musculo-skel. (Superficial) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | N | N | N | | N | N | | | | Cardiac Pediatric | N | N | N | | N | N | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral
Vessel | Peripheral vessel | | | | | | | | | | Other (Specify) | | | | | | | | N: subject of this submission. a Includes B+M. °Includes B+PWD. ² Includes Color Doppler (CD) ; Amplitude Doppler (AD); B+CD; B+AD. "B+PWD+CD; B+PWD+AD (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation = Yes, intended for this mode/use combination. Prescription use (per 21 CFR 801.109) Nancy C Hodgon (Division Sign Off) Division in Reproductiv Abdomin are radiose grai Devis bi 1k; Mumber ___ {11}------------------------------------------------ System: Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System_ Transducer: TC-200-LP (6 -- 9 MHz Linear Transducer) | Clinical Application | | | Mode of Operation | | | | | | |--------------------------|------------------------------------------------|---|-------------------|------|-----|-------------------|--------------------|-------| | General | Specific | B | Ma | PWDb | CWD | Color
Dopplerc | Combined
Modesc | Other | | (Track I Only) | (Tracks I & III) | | | | | | | | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal | N | N | N | | N | N | | | | Abdominal | N | N | N | | N | N | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | Fetal Imaging
& Other | Pediatric | N | N | N | | N | N | | | | Small Organ (Thyroid,
Breast, Testes, etc.) | N | N | N | | N | N | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel.
(Conventional) | N | N | N | | N | N | | | | Musculo-skel. (Superficial) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral
Vessel | Peripheral vessel | N | N | N | | N | N | | | | Other (Specify) | | | | | | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: N: subject of this submission. 4 Includes B+M. ്includes B+PWD. ² Includes Color Doppler (CD) ; Amplitude Doppler (AD); B+CD; B+AD. ªB+PWD+CD; B+PWD+AD (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109) Nancy C. Broydon (Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ {12}------------------------------------------------ System: Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System_ Transducer: TC-201-LP (5 -- 8 MHz Linear Transducer) | Clinical Application | | Mode of Operation | | | | | | | |---------------------------|------------------------------------------------|-------------------|----|------|-----|-------------------|--------------------|-------| | General
(Track I Only) | Specific
(Tracks I & III) | B | Ma | PWDb | CWD | Color
Dopplerc | Combined
Modesd | Other | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal | N | N | N | | N | N | | | | Abdominal | N | N | N | | N | N | | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | Fetal Imaging
& Other | Pediatric | N | N | N | | N | N | | | | Small Organ (Thyroid,
Breast, Testes, etc.) | N | N | N | | N | N | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skel.
(Conventional) | N | N | N | | N | N | | | | Musculo-skel. (Superficial) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral
Vessel | Peripheral vessel | N | N | N | | N | N | | | | Other (Specify) | | | | | | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: N: subject of this submission. Includes B+M. b Includes B+PWD. ് Includes Color Doppler (CD) ; Amplitude Doppler (AD); B+CD; B+AD. 4B+PWD+CD; B+PWD+AD (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109) Nancy C. Broughton (Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number _ {13}------------------------------------------------ _Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System | Transducer: TC-400-EP (Curved Linear 5 – 9 MHz Transvaginal Transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|--|-------------------|----|------|-----|-------------------|--------------------|-------| | Clinical Application | | | Mode of Operation | | | | | | | | General
(Track I Only) | Specific
(Tracks I & III) | | Ba | Ma | PWDb | CWD | Color
Dopplerc | Combined
Modesd | Other | | Ophthalmic | Ophthalmic | | | | | | | | | | | Fetal | | | | | | | | | | | Abdominal | | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | Fetal Imaging
& Other | Pediatric | | | | | | | | | | | Small Organ (Thyroid,
Breast, Testes, etc.) | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | N | N | N | | N | N | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | Musculo-skel.
(Conventional) | | | | | | | | | | | Musculo-skel. (Superficial) | | | | | | | | | | | Intra-luminal | | | | | | | | | | | Other (Specify) | | | | | | | | | | | Cardiac Adult | | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Other (Specify) | | | | | | | | | | Peripheral
Vessel | Peripheral vessel | | | | | | | | | | | Other (Specify) | | | | | | | | | N: subject of this submission. ª Includes B+M. System: ් Includes B+PWD. ് Includes Color Doppler (CD) ; Amplitude Doppler (AD); B+CD; B+AD. ªB+PWD+CD; B+PWD+AD (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109) Nancy C Houghton (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _ --- **Source:** [https://fda-staging.innolitics.com/device/K040409](https://fda-staging.innolitics.com/device/K040409) **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