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K Number
K040409
Device Name
LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM
Manufacturer
LARSEN & TOUBRO LIMITED
Date Cleared
2004-02-27

(9 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.
Device Description
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: Type "BF" Degree of protection against electric shock For ECG electrodes: 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 Pre-processing: Temporal averaging Tissue discrimination Colour maps Thresholding Flash Suppression Edge Enhancement M mode speed: 2s, 4s, and 8s D mode speed: 2s, 4s, and 8s Image Memory Size: 512 x 512 x 8 bits Grey Scale: 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 Axial 1 mm Lateral 1.025 mm Freq. 5 MHz Axial 0.65 mm Lateral 0.75 mm Freq. 7.5 MHz Axial 0.41 Lateral 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) 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
More Information

K946277, K991805

Not Found

No
The document describes standard ultrasound system specifications and image processing techniques, with no mention of AI or ML.

No
The device is described as a "Colour Doppler Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body," which indicates a diagnostic rather than therapeutic purpose.

Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body".

No

The device description clearly outlines physical hardware components such as dimensions, weight, power requirements, external ports, monitor, and probe connectors, indicating it is a physical ultrasound system, not software only.

Based on the provided information, the Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use clearly states "diagnostic ultrasound imaging or fluid flow analysis of the human body." This describes a device that interacts directly with the patient to produce images or analyze physiological processes within the body.
  • Device Description: The technical specifications and description detail a system for generating and processing ultrasound waves and displaying the resulting images. This is consistent with an in-vivo imaging device.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or performing tests on biological specimens outside the body, which are the defining characteristics of an IVD.

Therefore, this device falls under the category of an in-vivo diagnostic imaging system, not an in-vitro diagnostic device.

N/A

Intended Use / 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; specific indications for use a tabulated in Section 4.3 of this submission.
Transducer: TC-101-CP (2.5 - 5.0 MHz Curved Linear Array Transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Trans-vaginal, Musculo-skel. (Conventional), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
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: Cardiac Adult, Cardiac Pediatric.
Transducer: TC-200-LP (6 -- 9 MHz Linear Transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Breast, Testes, etc.), Musculo-skel. (Conventional), Peripheral vessel.
Transducer: TC-201-LP (5 -- 8 MHz Linear Transducer)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Breast, Testes, etc.), Musculo-skel. (Conventional), Peripheral vessel.
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: Trans-vaginal.

Product codes (comma separated list FDA assigned to the subject device)

90 IYN, IYO, and IYX

Device Description

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: Type "BF"
Degree of protection against electric shock for ECG electrodes: 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:

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

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 shocksClass I
Degree of protection against
electric shock
for ultrasound probes
For ECG electrodesType "BF"
Type 'CF"
Degree of protection against
hazard of explosionNot protected
Degree of protections against
ingress of liquidsIPXO
Power Requirements
AC input110 V AC
60 Hz single phase
FuseTwo (2) 12A, slow blow, glass cartridge fuses
in Line and Neutral
LoadTotal: 1000A
(System: 850 VA,
Aux. Output: 150 VA)
LeakageFood 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 ApplicationMode of Operation
General
(Track I Only)Specific
(Tracks I & III)BMaPWDbCWDColor
DopplercCombined
ModesdOther
OphthalmicOphthalmic
FetalNNNNN
AbdominalNNNNN
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Fetal Imaging
& OtherPediatricNNNNN
Small Organ (Thyroid,
Breast, Testes, etc.)NNNNN
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginalNNNNN
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel.
(Conventional)NNNNN
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac AdultNNNNN
CardiacCardiac PediatricNNNNN
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral
VesselPeripheral vesselNNNNN
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 ApplicationMode of Operation
General
(Track I Only)Specific
(Tracks I & III)BMaPWDbCWDColor
DopplercCombined
ModesdOther
OphthalmicOphthalmic
FetalNNNNN
AbdominalNNNNN
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Fetal Imaging
& OtherPediatricNNNNN
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)
CardiacCardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral
VesselPeripheral 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 ApplicationMode of Operation
General
(Track I Only)Specific
(Tracks I & III)BMPWDCWDColor
DopplerCombined
ModesOther
OphthalmicOphthalmic
Fetal Imaging
& OtherFetal
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)
CardiacCardiac AdultNNNNN
Cardiac PediatricNNNNN
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral
VesselPeripheral 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 ApplicationMode of Operation
GeneralSpecificBMaPWDbCWDColor
DopplercCombined
ModescOther
(Track I Only)(Tracks I & III)
OphthalmicOphthalmic
FetalNNNNN
AbdominalNNNNN
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Fetal Imaging
& OtherPediatricNNNNN
Small Organ (Thyroid,
Breast, Testes, etc.)NNNNN
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel.
(Conventional)NNNNN
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
CardiacCardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral
VesselPeripheral vesselNNNNN
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 ApplicationMode of Operation
General
(Track I Only)Specific
(Tracks I & III)BMaPWDbCWDColor
DopplercCombined
ModesdOther
OphthalmicOphthalmic
FetalNNNNN
AbdominalNNNNN
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Fetal Imaging
& OtherPediatricNNNNN
Small Organ (Thyroid,
Breast, Testes, etc.)NNNNN
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel.
(Conventional)NNNNN
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
CardiacCardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral
VesselPeripheral vesselNNNNN
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 ApplicationMode of Operation
General
(Track I Only)Specific
(Tracks I & III)BaMaPWDbCWDColor
DopplercCombined
ModesdOther
OphthalmicOphthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Fetal Imaging
& OtherPediatric
Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginalNNNNN
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel.
(Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
CardiacCardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral
VesselPeripheral 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 _