(15 days)
ATL HDI® 5000, Medison SA88 Plus, Cozumel ultrasound system
Not Found
No
The description focuses on standard ultrasound technology and image processing, with no mention of AI, ML, or related concepts. The system optimization is described as automatic based on user inputs, which is typical for modern ultrasound systems and doesn't necessarily imply AI/ML.
No
The "Intended Use / Indications for Use" section explicitly states that the device is for "Diagnostic ultrasound imaging or fluid flow analysis", and the "Device Description" states it is a "diagnostic ultrasound system". There is no mention of therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". Furthermore, the "Device Description" states that "C1 is a general purpose, highly portable, software-controlled. diagnostic ultrasound system" and that its analysis packages "provide information used for clinical diagnostic purposes."
No
The device description explicitly states it is a "software-controlled diagnostic ultrasound system" and mentions accepting "curved or linear transducers," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The description clearly states that this device is a diagnostic ultrasound system. It uses sound waves to create images of internal structures of the human body. This is an in vivo diagnostic method, meaning it is performed within the living body.
- Intended Use: The intended uses listed are all related to imaging various anatomical sites within the human body using ultrasound. There is no mention of analyzing samples taken from the body.
Therefore, the C1 ultrasound system, as described, falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
C1 intended uses as defined FDA guidance documents are:
- Fetal OB/GYN .
- Abdominal .
- Intraoperative (abdominal organs and vascular) ●
- Small Organs (breast, thyroid, testicle) ●
- Pediatric .
- Trans-vaginal .
- Peripheral Vessel ●
- Cardiac ●
- Musculo-skeletal (conventional) ●
- Neonatal Cephalic ●
- Trans-Rectal
Typical examinations performed using C1 system are:
- . General abdominal and pelvic studies including organ surveys, blood flow assessment, and retroperitoneal cavity studies.
- . Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall.
- Pediatric scans of organs, superficial, and bony structures. ●
- Monitoring procedures for infertility studies (other than in vitro fertilization).
- First, second and third trimester pregnancy studies. ●
- Neonatal head studies. .
- General cardiac studies in adults. .
- Prostate, prostate biopsy guidance, rectal wall studies
Product codes
90 IYN, 90 ITX, 90 IYO
Device Description
C1 is a general purpose, highly portable, software-controlled. diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, and Amplitude Doppler or in a combination of modes. C1 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes. C1 has an output display with two basic indices, a mechanical index (MI) and a thermal index (TI). One index is automatically displayed. MI is displayed in B-mode. TI is displayed in all other modes.
The C1 system is designed to accept a curved or linear transducer. All actions affecting the performance of the transducer are activated from the main system control panel.
The C1 system is designed to accept transducers of the following types and frequency:
frequency range: 2.0 - 7.0 MHz transducer types: Linear array Curved linear array
Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by the system software in response to user inputs such as depth, exam type, transducer, and optimize.
C1 has been designed to meet the following electromechanical safety standards:
- EN 60601-1 (IEC 601-1,) European Norm, Medical Electrical . Equipment
- UL 2601-1, Underwriters Laboratories Standards, Medical Electrical . Equipment
- C22.2 No. 601.1, Canadian Standards Association, Medical Electrical . Equipment
- CEI/IEC 1157:1992, International Electrotechnical Commission, . Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
- EN 60601-1-2 (IEC 601-1-2,) European Norm, Collateral Standard: . Electromagnetic Compatibility
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic Ultrasound
Anatomical Site
Fetal (OB/GYN), Abdominal (including intraoperative, abdominal organs, vascular, retroperitoneal cavity, prostate, and rectal wall), Small Organs (breast, thyroid, testicle), Pediatric (including organs, superficial, bony structures, neonatal cephalic, and cardiac), Trans-vaginal, Peripheral Vessel, Cardiac (adult), Musculoskeletal (conventional and superficial).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ATL HDI® 5000, Medison SA88 Plus, Cozumel ultrasound system
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
3/26/99 510(k) Premarket Notification
Modified Ultrasound Generator - February 20, 1999
K990806
C1 Ultrasound System
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1) Submitter's name, address, telephone number, contact person:
Howard Holman Director, Program Management and Compliance SonoSite, Inc. 19807 North Creek Parkway, Suite 200 Bothell, WA 98011-8214 (425) 487-7602
Date prepared: February 16, 1999
-
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/ Usual Name
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Diagnostic Ultrasound System with Accessories
Proprietary Name
C1 Ultrasound System (subject to change)
Classification Names
Ultrasonic Pulsed Doppler Imaging System | 90-IYN | 892.1550 |
---|---|---|
Diagnostic Ultrasonic Transducer | 90-ITX | 892.1570 |
Ultrasonic Pulsed Echo Imaging System | 90-IYO | 892.1560 |
3) Identification of the predicate or legally marketed device:
SonoSite, Inc. believes that C1 ultrasound system is substantially equivalent to the currently marketed ATL HDI® 5000 and Medison SA88 Plus diagnostic ultrasound systems and the previously cleared Cozumel ultrasound system.
1
4) Device Description:
C1 is a general purpose, highly portable, software-controlled. diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, and Amplitude Doppler or in a combination of modes. C1 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes. C1 has an output display with two basic indices, a mechanical index (MI) and a thermal index (TI). One index is automatically displayed. MI is displayed in B-mode. TI is displayed in all other modes.
The C1 system is designed to accept a curved or linear transducer. All actions affecting the performance of the transducer are activated from the main system control panel.
The C1 system is designed to accept transducers of the following types and frequency:
frequency range: 2.0 - 7.0 MHz transducer types: Linear array Curved linear array
Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by the system software in response to user inputs such as depth, exam type, transducer, and optimize.
C1 has been designed to meet the following electromechanical safety standards:
- EN 60601-1 (IEC 601-1,) European Norm, Medical Electrical . Equipment
- UL 2601-1, Underwriters Laboratories Standards, Medical Electrical . Equipment
- C22.2 No. 601.1, Canadian Standards Association, Medical Electrical . Equipment
- CEI/IEC 1157:1992, International Electrotechnical Commission, . Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
- EN 60601-1-2 (IEC 601-1-2,) European Norm, Collateral Standard: . Electromagnetic Compatibility
2
5) Intended Use:
C1 intended uses as defined FDA guidance documents are:
- Fetal OB/GYN .
- Abdominal .
- Intraoperative (abdominal organs and vascular) ●
- Small Organs (breast, thyroid, testicle) ●
- Pediatric .
- Trans-vaginal .
- Peripheral Vessel ●
- Cardiac ●
- Musculo-skeletal (conventional) ●
- Neonatal Cephalic ●
- Trans-Rectal
Typical examinations performed using C1 system are:
- . General abdominal and pelvic studies including organ surveys, blood flow assessment, and retroperitoneal cavity studies.
- . Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall.
- Pediatric scans of organs, superficial, and bony structures. ●
- Monitoring procedures for infertility studies (other than in vitro fertilization).
- First, second and third trimester pregnancy studies. ●
- Neonatal head studies. .
- General cardiac studies in adults. .
- Prostate, prostate biopsy guidance, rectal wall studies
6) Technological Characteristics:
This device operates identical to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as a 2D and M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, M-mode, and Amplitude Doppler) are the same as predicate devices identified in item 3. Transducer patient contact materials are biocompatible.
This device conforms to the Standard for Real-Time Display of Thermal
3
and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (AIUM/NEMA, 1992) for an on-screen display feature that provides information on potential thermal and cavitation bioeffect mechanisms. A user education program provides additional information so users may moderate the system's acoustic output in accordance with the ALARA (as low as reasonably achievable) principle.
The device's acoustic output limits are:
All Applications:
ISPTAd | 720 mW / cm2 | (Maximum) |
---|---|---|
TIS/TIB/TIC | 0.1 - 4.0 | (Range) |
Mechanical Index (MI) | 1.9 | (Maximum) |
ISPPAd | 0 - 700 W / cm2 | (Range) |
The limits are same as predicate Track 3 devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 26 1999
Sonosite, Inc. c/o TUV Product Service, Inc. Carol Stamp 1775 Old Highway 8 NW Suite 104 New Brighton, MN 55112
Re: K990806 C1 Ultrasound System Regulatory Class: II/21 CFR 892.1550, 21 CFR 892.1570 and 21 CFR 892.1560 Product Code: 90 IYN, 90 ITX and 90 IYO Dated: March 4, 1999 Received: March 11, 1999
Dear Mr. Stamp:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivations for use stated in the enclosure and we have had
marketed predicate devices marketed in interests communications for use sta marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enclosure) to legally Medical Device Amendments, or to devices that bevelop 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 provisions of the Actuale requirements for annual registerion,
and authersi
This determination of substantial equivalence applies to the following transducers intended for use with the Cl Ultrasound System, as described in your premarket notifications
Transducer Model Number
C7 - 4MHz IVT L7 - 4MHz Linear Array C4 - 2MHz Curves Array
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirent detemination assumes
for Medical Devices: General (GMB) Practice requirement, as set forth in the Quality System Reg for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic (QS
FDA will verify such assumptions . Railyre to compluguid . (2) CRP Part 800) pe FDA will verify such as not (2) ceation (21 certain and through periodic QS inspections, the addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal the Federal Register. Please not to your premarks notification does not affect any obligation your device in may have under sections 53 l and 542 of the Act for devices under the Electronic of the may obligation
may have under sections 53 l and 542 of the Act for devices under the E provisions, or other Federal laws or regulations.
5
Please be advised that the determination above Is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.
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 and additionally 809.10 for in vitro diagnostic devices), 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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".
6
Page 3 – Carol Stamp
If you have any questions regarding the content of this letter, please contact Robert Philllips, Ph.D.at (301) 594-1212.
Sincerely yours,
David A. Szyrman
for
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
7
System: C1 Ultrasound System
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 | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal | P | P | B+M | Note | ||||
Abdominal | P | P | B+M | Note | ||||
Intra-operative | ||||||||
(Abdominal organs and | ||||||||
vascular) | P | P | B+M | Note | ||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | P | P | B+M | Note | ||||
Small Organ (breast, | ||||||||
thyroid, testicles.) | P | P | B+M | Note | ||||
Neonatal Cephalic | P | P | B+M | Note | ||||
Adult Cephalic | ||||||||
Trans-rectal | N | N | B+M | Note | ||||
Trans-vaginal | P | P | B+M | Note | ||||
Trans-urethral | ||||||||
Trans-esoph. (non-Card.) | ||||||||
Musculo-skel. (Convent.) | P | P | B+M | Note | ||||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (spec.) | ||||||||
Cardiac | Cardiac Adult | P | P | B+M | Note | |||
Cardiac Pediatric | N | N | B+M | Note | ||||
Trans-esophageal (card.) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | P | B+M | Note | |||
Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Amplitude Doppler, combined B and Amplitude Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(k) K981505.
Note 2: Other includes Amplitude Doppler, combined B and Amplitude Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K990806
Prescription Use (Per 21 CFR 801.109)
Indications for Use
8
System: C1 Ultrasound System Transducer: C7-4 MHz IVT
:
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 | ||||||||
(Spec.) | Other | ||||||||
(Spec.) | |||||||||
Ophthalmic | Ophthalmic | ||||||||
Fetal | P | P | B+M | Note | |||||
Abdominal | |||||||||
Intra-operative | |||||||||
(Abdominal organs and | |||||||||
vascular) | |||||||||
Intra-operative (Neuro.) | |||||||||
Fetal Imaging | Laparoscopic | ||||||||
& Other | Pediatric | ||||||||
Small Organ (breast, | |||||||||
thyroid, testicles.) | |||||||||
Neonatal Cephalic | |||||||||
Adult Cephalic | |||||||||
Trans-rectal | N | N | B+M | Note | |||||
Trans-vaginal | P | P | B+M | Note | |||||
Trans-urethral | |||||||||
Trans-esoph. (non-Card.) | |||||||||
Musculo-skel. (Convent.) | |||||||||
Musculo-skel. (Superfic.) | |||||||||
Intra-luminal | |||||||||
Other (spec.) | |||||||||
Cardiac Adult | |||||||||
Cardiac | Cardiac Pediatric | ||||||||
Trans-esophageal (card.) | |||||||||
Other (spec.) | |||||||||
Peripheral | Peripheral vessel | ||||||||
Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Amplitude Doppler, combined B and Amplitude Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(k) K981505.
Note 2: Other includes Amplitude Doppler, combined B and Amplitude Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy.
David A. Szyman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K990806
Prescription Use (Per 21 CFR 801.109)
Indications for Use
9
System: C1 Ultrasound System Transducer: L7-4 MHz Linear Array
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 | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal Imaging | ||||||||
& Other | Fetal | P | P | B+M | Note | |||
Abdominal | P | P | B+M | Note | ||||
Intra-operative | ||||||||
(Abdominal organs and | ||||||||
vascular) | P | P | B+M | Note | ||||
Intra-operative (Neuro.) | ||||||||
Laparoscopic | ||||||||
Pediatric | P | P | B+M | Note | ||||
Small Organ (breast, | ||||||||
thyroid, testicles.) | P | P | B+M | Note | ||||
Neonatal Cephalic | P | P | B+M | Note | ||||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Card.) | ||||||||
Musculo-skel. (Convent.) | P | P | B+M | Note | ||||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (spec.) | ||||||||
Cardiac | Cardiac Adult | |||||||
Cardiac Pediatric | N | N | B+M | Note | ||||
Trans-esophageal (card.) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | P | B+M | Note | |||
Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Amplitude Doppler, combined B and Amplitude Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(k) K981505.
Note 2: Other includes Amplitude Doppler, combined B and Amplitude Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy
David h. Sezmm
Division Sign-Off Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K770206
Prescription Use (Per 21 CFR 801.109)
Indications for Use
10
System: C1 Ultrasound System Transducer: C4-2 MHz Curved Array
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 | |||||||
(Spec.) | Oth | |||||||
(Spec | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal | P | P | B+M | Note | ||||
Abdominal | P | P | B+M | Note | ||||
Intra-operative | ||||||||
(Abdominal organs and | ||||||||
vascular) | P | P | B+M | Note | ||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | P | P | B+M | Note | ||||
Small Organ (breast, | ||||||||
thyroid, testicles.) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Card.) | ||||||||
Musculo-skel. (Convent.) | ||||||||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (spec.) | ||||||||
Cardiac Adult | P | P | B+M | Note | ||||
Cardiac | Cardiac Pediatric | N | N | B+M | Note | |||
Trans-esophageal (card.) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | |||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Amplitude Doppler, combined B and Amplitude Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(k) K981505.
Note 2: Other includes Amplitude Doppler, combined B and Amplitude Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy
Yoril le. Sazhron
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K990806
Prescription Use (Per 21 CFR 801.109)
Indications for Use