BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B

{0}------------------------------------------------ D9. 1 of 4 Section S \$101) Surmeи y у PAGE 1 of 13 PAGES OCT 1 5 2007 # 510(k) Summary For BRODASOUND Model AL3C34A, AL7L50A, AL3C79B, AL7L24B, AT3C42B, AT3C52B, AT5L40B, AT3P32A, and AT3P42A Diagnostic Ultrasound Transducer Assemblies | 510(k) Number: | K070195 | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Broadsound Corporation<br>5F, No. 31, Shintai Road<br>Jupei City, Hsinchu 30252, Taiwan<br>Tel: 886-3-5539868, Fax: 886-3-5539808 | | Contact Person: | Jiann-Hwa Jeng, Ph.D., President & CEO | | Date Prepared: | August 30, 2007 | | Device Name:<br>Trade Name: | BROADSOUND | | Model Name: | AL3C34A, AL7L50A, AL3C79B, AL7L24B<br>AT3C42B, AT3C52B, AT5L40B, AT3P32A, AT3P42A | | Common Name: | Diagnostic Ultrasound Transducer Assembly,<br>Ultrasound Imaging Probe,<br>Medical Ultrasound Probe, or<br>Diagnostic Ultrasound Probe | | Classification Name: | Transducer, Ultrasonic, Diagnostic | | Classification Regulation: | 21 CRF 892.1570 | | Product Code: | 90ITX | | Class: | II | S10(k) Number: K070195 {1}------------------------------------------------ K070195 pg. 2 of 4 5 HQ(la Summary PAGE Car H FAKES ## Device Comparison: Legally marketed devices for substantial equivalence comparison are listed as following: | Subject Device | 510(k) Number | Model Name | Manufacturer | |----------------|------------------|---------------|-----------------------| | AL3C34A | K900805, K880900 | UST-934N-3.5 | Aloka Ltd. | | AL7L50A | K900805, K880900 | UST-5512U-7.5 | Aloka Ltd. | | AL3C79B | K983879 | UST-979-3.5 | Aloka Ltd. | | AL7L24B | K983879 | UST-5524-7.5 | Aloka Ltd. | | AT3C42B | K002003 | C5-2 | ATL Ultrasound Inc. | | | Marketed product | C4-2 | ATL Ultrasound Inc. | | AT3C52B | K002003 | C5-2 | ATL Ultrasound Inc. | | AT5L40B | K002003 | L7-4 | ATL Ultrasound Inc. | | AT3P32A | K974269, K961459 | Medison P4-2 | Medison America, Inc. | | | Marketed product | ATL P3-2 | ATL Ultrasound Inc. | | AT3P42A | K974269, K961459 | Medison P4-2 | Medison America, Inc. | | | Marketed product | ATL P4-2 | ATL Ultrasound Inc. | Each of above referenced transducer assemblies is substantially equivalent to its corresponding predicate device, and both of them are very similar to each other in terms of features and use parameters; as well, they are used on the same diagnostic ultrasound systems. Legally marketed devices that Broadsound replacement transducers are intended to replace with are summarized as following: | Broadsound New<br>Replacement Model | Predicate OEM<br>Transducer Model | Indicated System | |-------------------------------------|-----------------------------------|------------------| | AL3C34A | Aloka UST-934N-3.5 | Aloka SSD-500 | | AL7L50A | Aloka UST-5512U-7.5 | Aloka SSD-500 | | AL3C79B | Aloka UST-979-3.5 | Aloka SSD-900 | | AL7L24B | Aloka UST-5524-7.5 | Aloka SSD-900 | | AT3C42B | ATL C4-2 | ATL HDI 5000 | | AT3C52B | ATL C5-2 | ATL HDI 5000 | | AT5L40B | ATL L7-4 | ATL HDI 5000 | | AT3P32A | ATL P3-2 | ATL HDI 5000 | | AT3P42A | ATL P4-2 | ATL HDI 5000 | #### Description of Devices: The above referenced devices are replacement ultrasound transducers used with standard ultrasound Each of them consists of piezoelectric crystals covered with an acoustic lens, a scan head systems. that fits around the lens, a cable with strain relief devices on both ends, and a connector to attach the transducer to the ultrasound console. {2}------------------------------------------------ K070195 pg. 3 of 4 Section 510(k) Summary 彩金彩金 4 01 13 PAGES | Specification | AL3C34A | AL7L50A | AL3C79B | AL7L24B | |-----------------|-----------|----------|-----------|----------| | Frequency range | 5-2 MHz | 10-5 MHz | 5-2 MHz | 10-5 MHz | | Array type | Convex | Linear | Convex | Linear | | Field of view | 60 degree | 38 mm | 70 degree | 42 mm | | Element number | 72 | 72 | 120 | 120 | | Pitch | 1.0 mm | 0.6 mm | 0.6 mm | 0.375 mm | The specifications of each transducer assembly are listed as following: | Specification | AT3C42B | AT3C52B | AT5L40B | AT3P32A | AT3P42A | |-----------------|-----------|-----------|---------|-----------|-----------| | Frequency range | 4-2 MHz | 5-2 MHz | 7-4 MHz | 3-2 MHz | 4-2 MHz | | Array type | Convex | Convex | Linear | Phased | Phased | | Field of view | 75 degree | 75 degree | 40 mm | 90 degree | 90 degree | | Element number | 128 | 128 | 128 | 64 | 64 | | Pitch | 0.4 mm | 0.4 mm | 0.6 mm | 0.32 mm | 0.32 mm | Intended Use: The above referenced Broadsound transducer assemblies are intended for use, with standard ultrasound systems, in diagnostic ultrasound imaging or fluid flow analysis of the human body and to be operated by or under the direction of a physician. Their specific indications for use are listed as following: | | Model Name | Specific Indications of Use* | |---|------------|-------------------------------------------------------------| | 1 | AL3C34A | Abdominal, Fetal | | 2 | AL7L50A | Small organ, Peripheral vascular | | 3 | AL3C79B | Abdominal, Fetal, Pediatric | | 4 | AL7L24B | Small organ, Peripheral vascular | | 5 | AT3C42B | Abdominal, Fetal, Pediatric | | 6 | AT3C52B | Abdominal, Fetal, Pediatric | | 7 | AT5L40B | Abdominal, Pediatric, Peripheral vascular, Musculo-skeletal | | 8 | AT3P32A | Abdominal, Adult cephalic, Cardiac | | 9 | AT3P42A | Abdominal, Adult cephalic, Cardiac | {3}------------------------------------------------ K070195 pg-Hof 4 3 (A) (2) 3 (2) (2007) (2007) PAGE of 13 CAGE Characteristics of Technology: Each of above referenced Broadsound transducer assemblies is substantially equivalent to its corresponding predicate device, and both of them are very similar to each other in terms of features and use parameters; as well, they are used on the same diagnostic ultrasound systems. No new technology is employed on these devices. ## Safety Testing: Electrical, Mechanical, thermal, and biocompatible safety testing were conducted on these devices; the results are included in the submission. ## Performance Testing: Each of above referenced ultrasound transducer assemblies and its corresponding predicate device were tested for acoustic output and found statistically comparable to each other. Performance testing was also conducted and included in the submission. - # CE Mark: All above referenced devices have been granted CE0197 mark of European Union by TÜV Rheinland Product Safety GmbH, Germany since April 2006, and the pertinent information is included in the submission. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # OCT 1 5 2007 Jiann-Hwa Jeng, Ph.D. President & CEO Broadsound Corporation 5F, No.31, Shintai Road JUPEI CITY HSINCHU 30252 TAIWAN Re: K070195 Trade/Device Name: BROADSOUND Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: August 31, 2007 Received: September 4, 2007 Dear Dr. Jeng: 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 BROADSOUND, as described in your premarket notification: | Transducer Model Number | | |--------------------------------------------------------------------------------|---| | and and the first and the first of the first of the American American American | I | | AL3C34A | AT3C52B | |---------|---------| | AL7L50A | AT5L40B | | AL3C79B | AT3P32A | | AL7L24B | AT3P42A | | AT3C42B | | {5}------------------------------------------------ ## Page 2 - Dr. Jeng 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 (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 {6}------------------------------------------------ Page 3 – Dr. Jeng If you have any questions regarding the content of this letter, please contact Ewa Czerska, MD at (240) 276-3666. Sincerely yours, Jouyi Tri Whang for Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure(s) {7}------------------------------------------------ Section 4 Indications For Use Statement PAGE: 1 of 1 PAGES # Indications For Use Statement | 510(k) Number: | K070195 | |----------------|----------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Diagnostic Ultrasound Transducer Assembly,<br>Ultrasound Imaging Probe,<br>Medical Ultrasound Probe, or<br>Diagnostic Ultrasound Probe | | Device Name | | | Trade Name: | BROADSOUND | | Model Name: | AL3C34A, AL7L50A, AL3C79B, AL7L24B,<br>AT3C42B, AT3C52B, AT5L40B, AT3P32A, AT3P42A | The above referenced devices are replacement ultrasound transducers intended to be used with standard ultrasound systems in diagnostic ultrasound imaging or fluid flow analysis of the human body and to be operated by or under the direction of a physician. Their specific indications for use are listed as following: | | Model Name | Specific Indications of Use* | |---|------------|-------------------------------------------------------------| | 1 | AL3C34A | Abdominal, Fetal | | 2 | AL7L50A | Small organ, Peripheral vascular | | 3 | AL3C79B | Abdominal, Fetal, Pediatric | | 4 | AL7L24B | Small organ, Peripheral vascular | | 5 | AT3C42B | Abdominal, Fetal, Pediatric | | 6 | AT3C52B | Abdominal, Fetal, Pediatric | | 7 | AT5L40B | Abdominal, Pediatric, Peripheral vascular, Musculo-skeletal | | 8 | AT3P32A | Abdominal, Adult cephalic, Cardiac | | 9 | AT3P42A | Abdominal, Adult cephalic, Cardiac | Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part21 CFR801 Subpart D) ![]() (Division Sign-Off) Division of Reproductive. Abdominal, and Radiological Devices 510(k) Number Over-The-Counter Use _ (Part21 CFR801 Subpart C) {8}------------------------------------------------ 510(K) Number (if known): K070195 Device Name (transducer): BROADSOUND AL3C34A Ultrasound System: Aloka SSD 500 series Indications for Use: Diagnostic ultrasound imaging of the human body as follows: | | Modes of Operation | | | | | | | | | | |--------------------------|--------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | P | P | | | | | | Note 1 | | | Abdominal | | P | P | | | | | | Note 1 | | | Intraoperative (specify) | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | Conventional | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared by FDA under K900805 and K88090; E = added under Appendix E Note 1: Combined application includes B/M mode. #### Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number {9}------------------------------------------------ Section 5 510(k) Summary PAGE 6 of 13 PAGES . ## Diagnostic Ultrasound Indications for Use Form | 510(K) Number (if known): | K070195 | |---------------------------|----------------------| | Device Name (transducer): | BROADSOUND AL7L50A | | Ultrasound System: | Aloka SSD 500 series | Indications for Use: Aloka SSD 500 series Diagnostic ultrasound imaging of the human body as follows: | | Modes 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 | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative<br>(specify) | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ<br>(specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | P | P | | | | | | Note 1 | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | Conventional | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared by FDA under K900805 and K88090; E = added under Appendix E Note 1: Combined application includes B/M mode. #### Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Wha (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number {10}------------------------------------------------ - | 510(K) Number (if known): | | |---------------------------|--| | Device Name (transducer): | | | Ultrasound System: | | K070195 BROADSOUND AL3C79B Aloka SSD 900 series Indications for Use: Diagnostic ultrasound imaging of the human body as follows: | | Modes 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 | | | | | | Note 1 | | | Abdominal | | P | P | | | | | | Note 1 | | | Intraoperative<br>(specify) | | | | | | | | | | | | Pediatric | | P | P | | | | | | Note 1 | | | Small Organ<br>(specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal<br>Conventional | | | | | | | | | | | | Musculo-skeletal<br>Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared by FDA under K983879; E = added under Appendix E Note 1: Combined application includes B/M mode. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Division of Reproductive, Abdominal, a Radiological Devices 510(k) Number {11}------------------------------------------------ Section 5 510(k) Summary PAGE 8 of 13 PAGES ### Diagnostic Ultrasound Indications for Use Form 510(K) Number (if known): K070195 Device Name (transducer): BROADSOUND AL7L24B Ultrasound System: Aloka SSD 900 series Indications for Use: Diagnostic ultrasound imaging of the human body as follows: | | Modes 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 | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative<br>(specify) | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ<br>(specify) | | P | P | | | | | | Note 1 | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | P | P | | | | | | Note 1 | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | Conventional | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared by FDA under K983879; E = added under Appendix E Note 1: Combined application includes B/M mode. Small organ applications: Breast, Testes, Thyroid #### Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) louis Whan (Divided Ben. Off) (Division Sign-Off) Division of Reproductive. Abdominal, a Radiological Devices 510(k) Number {12}------------------------------------------------ 510(K) Number (if known): Device Name (transducer): Ultrasound System: K070195 BROADSOUND AT3C42B ATL HDI 5000 series Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Modes of Operation | | | | | | | | | | |--------------------------|--------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | P | P | P | | P | P | | Note 1 | | | Abdominal | | P | P | P | | P | P | | Note 2 | | | Intraoperative (specify) | | | | | | | | | | | | Pediatric | | P | P | P | | P | P | | Note 2 | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | Conventional | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared by FDA under K002003; E = added under Appendix E Note 1: Combined application includes B/M mode. Note 2: Combined applications include B/M, PWD/Color Doppler, and PWD/ Power Doppler modes. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Tony M. White ctive. Abdomin Badiolo 510(k) Num {13}------------------------------------------------ 510(K) Number (if known): K070195 Device Name (transducer): Ultrasound System: Indications for Use: BROADSOUND AT3C52B ATL HDI 5000 series Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Modes 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 | | Note 1 | | | Abdominal | | P | P | P | | P | P | | Note 2 | | | Intraoperative<br>(specify) | | | | | | | | | | | | Pediatric | | P | P | P | | P | P | | Note 2 | | | Small Organ<br>(specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal<br>Conventional | | | | | | | | | | | | Musculo-skeletal<br>Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared by FDA under K002003; E = added under Appendix E Note 1: Combined application includes B/M mode. Note 2: Combined applications include B/M, PWD/Color Doppler, and PWD/ Power Doppler modes. Concurrence of CDRH, Office of Device Evaluation (ODE) /Prescription Use (Per 21 CFR 801.109) (Divisio Division of Reproductive, Abdominal, Radiological Devices 510(k) Number {14}------------------------------------------------ 510(K) Number (if known): K070195 Device Name (transducer): BROADSOUND AT5L40B Ultrasound System: ATL HDI 5000 series Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Modes 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 | | | | | | | | | | | | Abdominal | | P | P | P | | Color<br>Doppler | P | | Note 1 | | | Intraoperative<br>(specify) | | | | | | | | | | | | Pediatric | | P | P | P | | Color<br>Doppler | P | | Note 1 | | | Small Organ<br>(specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | P | P | P | | Color<br>Doppler | | | Note 1 | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal | | P | P | P | | Color<br>Doppler | | | Note 1 | | | Conventional | | | | | | | | | | | | Musculo-skeletal<br>Superficial | | P | P | P | | Color<br>Doppler | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared by FDA under K002003; E = added under Appendix E Note 1: Combined applications include B/M, PWD/Color Doppler, and PWD/ Power Doppler modes. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Vorge 7. Wh (Division Sign-Off) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number {15}------------------------------------------------ 510(K) Number (if known): K070195 Device Name (transducer): Ultrasound System: ATL HDI 5000 series Indications for Use: BROADSOUND AT3P32A Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | |-------------------------------|---|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------| | Ophthalmic | | | | | | | | | | | | Fetal | | P | P | P | | P | P | | Note 1 | | | Abdominal | | P | P | P | P | P | P | | Note 2 | | | Intraoperative (specify) | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | P | P | P | P | P | P | | Note 2 | | | Cardiac | | P | P | P | P | P | P | | Note 2 | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared by FDA under K974269 & K961459; E = added under Appendix E Note 1: Combined application includes B/M mode. Note 2: Combined applications include PWD/Color Doppler and PWD/ Power Doppler modes.. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number {16}------------------------------------------------ 510(K) Number (if known): K070195 Device Name (transducer): BROADSOUND AT3P42A Ultrasound System: ATL HDI 5000 series Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Modes 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 | | Note 1 | | | | Abdominal | | P | P | P | P | P | P | | Note 2 | | | | Intraoperative | | | | | | | | | | | | | (specify) | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | Small Organ | | | | | | | | | | | | | (specify) | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | P | P | P | P | P | P | | Note 2 | | | | Cardiac | | P | P | P | P | P | P | | Note 2 | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | | Conventional | | | | | | | | | | | | | Musculo-skeletal<br>Superficial | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | N = new indication; P = previously cleared by FDA under K974269 & K961459; E = added under Appendix E Note 1: Combined application includes B/M mode. Note 2: Combined applications include PWD/Color Doppler and PWD/ Power Doppler modes.. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Sign-Off) on of Reproductive, Abdominal, and cal Devices