(9 days)
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.
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
This document is a 510(k) Pre-market Notification for the Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System. It is an older document (dated 2003, cleared in 2004) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study with acceptance criteria and device performance as might be found in a more recent or novel device submission.
Therefore, the information you've requested regarding acceptance criteria and a study proving their fulfillment is not explicitly detailed in this document in the manner typically seen for performance claims of AI/CADe devices.
Instead, the submission for this diagnostic ultrasound system relies on demonstrating that its technical specifications and intended uses are substantially equivalent to already legally marketed predicate devices (TETRAD 2300 E/U Ultrasound Imaging System and Acuson Aspen System). The regulatory approval is based on safety and effectiveness being comparable to these existing devices, rather than a clinical trial demonstrating specific performance metrics against pre-defined acceptance criteria for a novel algorithm.
Here's a breakdown of what can be extracted or inferred based on the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy are provided in the document, nor are there explicit "reported device performance" values against such criteria. This type of detail is typical for software algorithms making diagnostic claims, which this ultrasound system itself is not directly. The "performance" assessment for this device is primarily through technical specifications and comparison to predicate devices.
The closest we get to "performance" are the "Imaging resolution" specifications, which are inherent physical properties of the ultrasound system:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Imaging Resolution (measured in water, assuming f/2) | |
| Axial Resolution (3 MHz) | 1 mm |
| Axial Resolution (5 MHz) | 0.65 mm |
| Axial Resolution (7.5 MHz) | 0.41 mm |
| Lateral Resolution (3 MHz) | 1.025 mm |
| Lateral Resolution (5 MHz) | 0.75 mm |
| Lateral Resolution (7.5 MHz) | 0.49 mm |
Note: These are technical specifications, not clinical performance metrics based on patient studies.
2. Sample size used for the test set and data provenance:
- Sample Size: Not applicable/Not mentioned. The submission relies on technical specifications and substantial equivalence, not a clinical test set for performance evaluation.
- Data Provenance: Not applicable/Not mentioned. There is no clinical data presented.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable/Not mentioned, as no clinical test set for ground truth establishment is described.
4. Adjudication method for the test set:
- Not applicable/Not mentioned, as no clinical test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This submission is for a conventional ultrasound imaging system, not an AI or CADe device. Therefore, the concept of human readers improving with AI assistance is not relevant to this document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This is not an algorithm being submitted for clearance, but an ultrasound machine.
7. The type of ground truth used:
- Not applicable/Not mentioned, as no clinical ground truth for a test set is described. The "ground truth" for proving this device's safety and effectiveness relies on its technical specifications meeting established standards and being comparable to predicate devices.
8. The sample size for the training set:
- Not applicable/Not mentioned, as there is no AI/machine learning algorithm being submitted that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned, as there is no AI/machine learning algorithm or training set described.
Summary of Study Type:
The "study" or evidence provided in this 510(k) submission is primarily:
- Technical Bench Testing and Specifications: The document lists detailed system and imaging specifications (e.g., dimensions, power requirements, imaging resolution in water, array types, frequency ranges). These specifications are inherently measurable and demonstrate the device's technical capabilities.
- Substantial Equivalence Comparison: The core of the 510(k) is the comparison of these technical specifications and the intended uses of the Larsen & Toubro SENORITA system to two predicate devices: TETRAD 2300 E/U Ultrasound Imaging System and Acuson Aspen System. The argument for clearance is that the new device performs within similar parameters and has similar intended uses as these already cleared devices, thus implying comparable safety and effectiveness.
- Compliance with Standards: The document mentions compliance with safety standards like IEC 60601 and UL2601, indicating that the device has undergone testing to ensure electrical and medical device safety.
In essence, this 510(k) demonstrates the device meets the regulatory requirements for clearance by showing its technical characteristics are similar to existing, legally marketed devices, rather than through a clinical performance study with specific acceptance criteria for diagnostic accuracy.
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K04 0409
FEB 27 2004
510(k) Summary for Larsen & Toubro Limited SENORITA Colour Doppler Ultrasound System
-
- SPONSOR
Larsen & Toubro Limited Medical Equipment & Systems SBU KIADB Industrial Area Hebbal, Hootagalli Mysore - 570018 Karnataka, INDIA
- SPONSOR
| 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 ColourDoppler 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 againstelectric shocks | Class I |
|---|---|
| Degree of protection againstelectric shockfor ultrasound probesFor ECG electrodes | Type "BF"Type 'CF" |
| Degree of protection againsthazard of explosion | Not protected |
| Degree of protections againstingress of liquids | IPXO |
| Power RequirementsAC input | 110 V AC60 Hz single phase |
| Fuse | Two (2) 12A, slow blow, glass cartridge fusesin 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 rotationRotation of consoleMonitor tilt | Keyboard +/- 30°+/-30 |
| External Ports | FDDCDRWParallel port-inkjet printerUSB port (rear panel) Laser printerRJ45 (LAN) port - NetworkingVGA port-SVGA monitor (slave)DIN Port-FootswitchAudio Port (real panel) Relay outAudio port (front panel) HeadphoneUSB port (front panel) Thumb DriveAuxiliary 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 SafetyStandards as per IEC 60601 |
| Language | English |
| Technical Specifications | |
| Operating System | Windows 2000 |
| Probe Connectors | Two (2) ITT Cannon DL 156 connectors |
| Options | Colour DopplerPW 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 ProcessingGeneral | FocusMultifocusDynamic RangeSensitivityPersistence |
{2}------------------------------------------------
{3}------------------------------------------------
| Pre-processingM mode speedD mode speedImage Memory SizeGrey Scale | Temporal averagingTissue discriminationColour mapsThresholdingFlash SuppressionEdge Enhancement2s, 4s, and 8s2s, 4s, and 8s512 x 512 x 8 bits256 levels | ||
|---|---|---|---|
| Image Specifications | |||
| Array types | LinearCurved 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 colorSelectable gray maps | ||
| Imaging resolution | (Best case, measured in water, assuming f/2for lateral resolution measurement)Freq.3 MHz5 MHz7.5 MHz | Axial1 mm0.65 mm0.41 | Lateral1.025 mm0.75 mm0.49 mm |
| Magnification | Magnification factors: 1.5, 1.8, 2.0 real timeimages | ||
| Image orientation | Horizontal (left/right) andVertical (up/down) inversion of image | ||
| Probes supported | Standard AbdominalEndovaginalTightly curved CardiovascularVascular | ||
| 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 | DynamicUpdated every 1.5 mm in depthErrors ≤ 10° in the 3 to 12 MHz rangeEnvelope delays switched between transmitzonesTransmit focus increment - 10 nsTransmit waveform - bipolar burst150 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 | ColorDopplerc | CombinedModesd | 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) | ||||||||
| PeripheralVessel | 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 | ColorDopplerc | CombinedModesd | 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) | ||||||||
| PeripheralVessel | 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 | ColorDoppler | CombinedModes | 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) | ||||||||
| PeripheralVessel | 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 | ColorDopplerc | CombinedModesc | 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) | ||||||||
| PeripheralVessel | 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 | ColorDopplerc | CombinedModesd | 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) | ||||||||
| PeripheralVessel | 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 | ColorDopplerc | CombinedModesd | 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) | |||||||||
| PeripheralVessel | 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 _
§ 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.