SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM
Device Facts
| Record ID | K072541 |
|---|---|
| Device Name | SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM |
| Applicant | Senorx, Inc. |
| Product Code | ITX · Radiology |
| Decision Date | Sep 25, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The SenoSonix Ultrasound Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. The ultrasound module is intended for use in obstetrics/gynecology and general radiology examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of the ultrasound system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), small organ (breast, thyroid, testicle), pediatric and fetal imaging.
Device Story
SenoSonix integrates a percutaneous ultrasound-guided, vacuum-assisted biopsy device and an ultrasound imaging system into a single console. Input consists of ultrasound signals from transducers; system processes these to generate 2D, time-motion, and biometric images. Device used by physicians in clinical settings to visualize breast abnormalities and guide biopsy needle placement for tissue extraction. Output includes real-time ultrasound visualization and biopsy control via touch screen. Clinical benefit includes minimally invasive diagnostic sampling of breast tissue for histologic examination. System shares console, keyboard, and display components to streamline biopsy and imaging workflows.
Clinical Evidence
Bench testing only. No clinical data provided. Substantial equivalence is based on design, material, and technological similarities to previously cleared predicate devices.
Technological Characteristics
System integrates vacuum-assisted biopsy control and diagnostic ultrasound imaging. Features two flat panel displays (one for imaging, one for user operation/control). Transducers include convex (C5-2/60) and linear (L14-5/38, L14-5W/60, L9-4/38) models. Operates via pulsed echo and pulsed Doppler imaging. Uses same biopsy and ultrasound probes as predicates. Materials and manufacturing processes are identical to previously cleared devices.
Indications for Use
Indicated for patients requiring diagnostic breast tissue sampling of abnormalities. Ultrasound module indicated for use in obstetrics/gynecology and general radiology for soft tissue diagnosis/evaluation (abdominal, small parts, peripheral vascular, MSK, small organ, pediatric, fetal). No specific contraindications listed.
Regulatory Classification
Identification
A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.
Predicate Devices
- SenoCor 360 Circumferential Vacuum-Assisted Biopsy Device (K023923)
- SenoRx Biopsy Device II (K040842)
- Sonix Ultrasound Scanner (K061827)
Related Devices
- K980423 — SONOPSY LA SYSTEM · Neovision Corp. · Aug 7, 1998
- K013641 — SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS · Senorx, Inc. · Jan 29, 2002
- K252681 — EnCor EnCompass Breast Biopsy and Tissue Removal System · Bard Peripheral Vascular, Inc. · Dec 12, 2025
- K111100 — ENCOR ENSPIRE BREAST BIOPSY SYSTEM · C.R. Bard, Inc. · Jun 16, 2011
- K192948 — EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G · Bard Peripheral Vascular, Inc. · Nov 7, 2019
Submission Summary (Full Text)
{0}------------------------------------------------
K07254/
Image /page/0/Picture/1 description: The image shows the word "SENORx" in a stylized font. The letters are black and the word is centered. The "O" in the word is replaced by a ribbon.
SEP 2 5 2007
#### 5. 510(K) SUMMARY
| Prepared date | August 21, 2007 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) owner | SenoRx, Inc.<br>11 Columbia<br>Aliso Viejo, CA 92656<br>P. 949.362.4800 F. 949.362.3200 |
| Contact person | Eben Gordon |
| Device name | SenoSonix Ultrasound Breast Biopsy System |
| Common name | Biopsy device<br>Ultrasound Imaging System |
| Classification name | Gastroenterology-urology biopsy instrument 876.1075 KNW |
| | Diagnostic Ultrasound Module<br>Ultrasonic Pulsed Doppler Imaging System 892.1550 TYN<br>Ultrasonic Pulsed Echo Imaging System 892.1560 IYO<br>Diagnostic Ultrasound Transducer 892.1570 ITX |
| Review category | Tier II |
| Regulatory class | II |
| Predicate device | K023923 SenoCor 360 Circumferential Vacuum-Assisted<br>Biopsy Device<br>K040842 SenoRx Biopsy Device II<br>K061827 Sonix Ultrasound Scanner |
| Decision date | 12/11//2002 (K023923)<br>4/30/2004 (K040842)<br>8/4/2006 (K061827) |
| Device description | The SenoSonix System is a percutaneous ultrasound-guided,<br>vacuum-assisted biopsy device which is intended for use in<br>providing breast tissue samples for diagnostic sampling of breast<br>abnormalities. |
| | The SenoSonix System integrates the functions of the existing<br>SenoRx Control Module (K023923) and Vacuum System<br>(K023923) into a single console. An added feature of the<br>SenoSonix System is the integration of Ultrasonix Medical's<br>Sonix Ultrasound Scanner (K061827). |
| | The SenoSonix System has 2 flat panel displays. One displays<br>the ultrasound image and the other is for user operation and |
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the word "SenORx" in a stylized font. The letters are large and bold, with a slight serif. There is some noise or distortion in the middle of the word, between the "N" and the "O". The overall impression is of a logo or brand name.
### Indications for use
Summary of substantial equivalence
control. The biopsy module will be controlled by the small window on the touch screen when the biopsy tab is selected.
The SenoSonix Ultrasound Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The ultrasound module is intended for use in obstetrics/gynecology and general radiology examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies.
The specific intended uses of the ultrasound system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), small organ (breast, thyroid, testicle), pediatric and fetal imaging.
The indications for use for the SenoSonix System are a sub-set of the predicate devices. The design changes that have occurred to the SenoRx Biopsy System and the Sonix Ultrasound System are limited to those to take advantage of a shared console, keyboard, and display.
The software is only changed to integrate the functionality of the control module, vacuum system, and ultrasound module into a common console.
The SenoSonix System has the following similarities to that of the previously cleared predicate devices:
- . Has the same intended use;
- . Uses the same operating principle and has not altered the fundamental technology:
- . Incorporates the same biopsy and ultrasound probes;
- Incorporates the same patient contacting materials; and
- t Has the same manufacturing materials and processes
In summary, the SenoSonix Ultrasound Breast Biopsy System described in this submission is, in our opinion, substantially equivalent to the predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The caduceus is depicted with a series of curved lines that resemble a stylized bird or wing-like shape. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2007
SenoRx, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K072541
Trade/Device Name: SenoSonix Ultrasound Breast Biopsy System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 7, 2007 Received: September 10, 2007
Dear Mr. Job:
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.
This determination of substantial equivalence applies to the following transducers intended for use with the SenoSonix Ultrasound Breast Biopsy System, as described in your premarket notification:
Transducer Model Number
C5-2/60 convex 1/5MHz 60mm radius L14-5/38 linear 5/12MHz 38mm L14-5W/60 linear 5/12MHz 60mm L9-4/38 linear 4/9MHz 38mm
{3}------------------------------------------------
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 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.
Sincerely vours.
Ayu Tri Whay
Gr Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
# SenoSonix Ultrasound Module
## Diagnostic Ultrasound Indications for Use Form
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Clinical Application | Mode of Operation | | | | | | | | | |
|-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | N | N (a) | N (b) |
| Abdominal | | N | N | N | N | N | N | N | N (a) | N (b) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | N | N (a) | N (b) |
| Small Organ (specify) | | N | N | N | | N | N | N | N (a) | N (b) |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | N | N (a) | N (b) |
| Laparoscopic | | | | | | | | | | |
| MSK Conventional | | N | N | N | | N | N | N | N (a) | N (b) |
| MSK Superficial | | N | N | N | | N | N | N | N (a) | N (b) |
| Other (specify) (c) | | | | | | | | | | |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
### Additional Comments:
Small Organ: breast, thyroid, testicle
Intraoperative: abdominal organs and vascular
(a) B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
(b) Freehand 3D imaging, live 3D imaging, Directional Power Doppler (DPD)
### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
louis K. Whing
(Divisi Division o Radiolog 510(k) Num
{5}------------------------------------------------
# C5-2/60 convex 1/5MHz 60mm radius transduccr
## Diagnostic Ultrasound Indications for Use Form
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Mode of Operation | | | | | | | | | | |
|-----------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P (a) | P (b) |
| Abdominal | | P | P | P | | P | P | P | P (a) | P (b) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | P | P (a) | P (b) |
| Small Organ (specify) | | P | P | P | | P | P | P | P (a) | P (b) |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P (a) | P (b) |
| Laparoscopic | | | | | | | | | | |
| MSK Conventional | | P | P | P | | P | P | P | P (a) | P (b) |
| MSK Superficial | | P | P | P | | P | P | P | P (a) | P (b) |
| Other (specify) | | | | | | | | | | |
N=new indication; P=previously cleared by FDA (Ultrasonix Medical Corp. in K061827); B=added under Appendix E
#### Additional Comments:
Small Organ: breast, thyroid, testicle
- (a) BM, B/PWD, B/CFM/PWD, B/AD/PWD, B/D/PWD, B/CFM/CWD, B/AD/CWD, B/D/D/CWD, B/D/D/CWD
(b) Freehand 3D imaging, Directional Power Doppler (DPD), imaging for guidance of biogry
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Aonni M. Whang
(Division Sign Off)
{6}------------------------------------------------
## L14-5/38 linear 5/12MHz 38mm transducer
### Diagnostic Ultrasound Indications for Use Form
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| | Mode of Operation | | | | | | | | | |
|-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P (a) | P (b) |
| Abdominal | | P | P | P | | P | P | P | P (a) | P (b) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | P | P (a) | P (b) |
| Small Organ (specify) | | P | P | P | | P | P | P | P (a) | P (b) |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P (a) | P (b) |
| Laparoscopic | | | | | | | | | | |
| MSK Conventional | | P | P | P | | P | P | P | P (a) | P (b) |
| MSK Superficial | | P | P | P | | P | P | P | P (a) | P (b) |
| Other (specify) | | | | | | | | | | |
N=new indication (previously cleared by Utrasonix Medical Corp. in K061827); P=previously cleared by FDA; E
### Additional Comments:
Small Organ: breast, thyroid, testicle
- (a) B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/DPD/CWD
(b) Freehand 3D imaging, Directional Power Doppler (DPD), imaging for guidance of biopsy
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Torgu M. Whan
510(k) N
{7}------------------------------------------------
## L14-5W/60 linear 5/12MHz 60mm transducer
### Diagnostic Ultrasound Indications for Use Form
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| | Mode of Operation | | | | | | | | | |
|-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P (a) | P (b) |
| Abdominal | | P | P | P | | P | P | P | P (a) | P (b) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | P | P (a) | P (b) |
| Small Organ (specify) | | P | P | P | | P | P | P | P (a) | P (b) |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P (a) | P (b) |
| Laparoscopic | | | | | | | | | | |
| MSK Conventional | | P | P | P | | P | P | P | P (a) | P (b) |
| MSK Superficial | | P | P | P | | P | P | P | P (a) | P (b) |
| Other (specify) | | | | | | | | | | |
N=new indication (previously cleared by Ultrasonix Medical Corp. in K061827); P=previously cleared by FDA; E=added under Appendix E
### Additional Comments:
Small Organ: breast, thyroid, testicle
- (a) B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
(b) Freehand 3D imaging, Directional Power Doppler (DPD), imaging for guidance of biopsy
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Louie M. White
(Division Sign-Off)
Radiol 510(k) Nu
{8}------------------------------------------------
## L9-4/38 linear 4/9MHz 38mm transducer
## Diagnostic Ultrasound Indications for Use Form
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| | | Mode of Operation | | | | | | | | |
|-----------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P (a) | P (b) |
| Abdominal | | P | P | P | | P | P | P | P (a) | P (b) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | P | P (a) | P (b) |
| Small Organ (specify) | | P | P | P | | P | P | P | P (a) | P (b) |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P (a) | P (b) |
| Laparoscopic | | | | | | | | | | |
| MSK Conventional | | P | P | P | | P | P | P | P (a) | P (b) |
| MSK Superficial | | P | P | P | | P | P | P | P (a) | P (b) |
| Other (specify) | | | | | | | | | | |
N=new indication (previously cleared by Ultrasonix Medical Corp. in K0618278 K042326); P=previously cleared by FDA; E=added under Appendix E
Additional Comments:
Small Organ: breast, thyroid, testicle
- (a) B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
- (b) Freehand 3D imaging, Directional Power Doppler (DPD), imaging for guidance of biopsy
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Torrie M. Whan
510(k) Nu
{9}------------------------------------------------
#### র্বা INDICATIONS FOR USE
510(k) Number (if known):
SenoSonix Ultrasound Breast Biopsy System 510(k) Submission Device Name:
Indications for Use:
The SenoSonix Ultrasound Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
The ultrasound module is intended for use in obstetrics/gynecology and general radiology examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies.
The specific intended uses of the ultrasound system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), small organ (breast, thyroid, testicle), pediatric and fetal imaging.
Prescription Use X . . .
AND/OR
Over the Counter Use with a
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Lone M. Whang
Page of
12
