(8 days)
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and there is no description of training or test sets, which are typical for AI/ML-based devices.
No
The "Intended Use" section clearly states that the device is for "studies" (e.g., fetal, abdominal, cardiac), implying diagnostic rather than therapeutic purposes.
Yes
The APLIO is an ultrasound system intended for conducting various types of studies (fetal, abdominal, cardiac, etc.) across multiple anatomical sites, which are inherently diagnostic in nature for medical evaluation.
No
The device description explicitly states it is a "mobile system" and employs "a wide array of probes," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used for various imaging studies of different anatomical sites within the body. This is characteristic of diagnostic imaging devices, not IVDs.
- Device Description: The description clearly states it's an Ultrasound System, which is an imaging modality.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body, which is the defining characteristic of an IVD. The information focuses on imaging the body directly.
Therefore, the APLIO Ultrasound System is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The APLIO is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial) and laparoscopic.
Product codes
IYN, IYO, ITX
Device Description
The APLIO Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic Pulsed Doppler Imaging, Ultrasonic Pulsed Echo Imaging
Anatomical Site
Not Found
Indicated Patient Age Range
Fetal, Pediatric, Neonatal, Adult
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
510(k) Summary of Safety and Effectiveness: 21 CFR 807.92
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
|---|---|
| Address: | PO Box 2068,2441 Michelle Drive Tustin, CA 92781-2068 |
| Contact: | Paul Biggins, Regulatory Affairs Specialist |
| Telephone No.: | (714) 730-5000 |
| 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - | 1 | |||||
|---|---|---|---|---|---|---|
| And of address on and | - | t | A |
3
| Device Proprietary Name: | SSA-770A, Aplio Ultrasound System |
|---|---|
| Common Name: | Diagnostic ultrasound system |
NOV 1 3 2001
Classification:
| Regulatory Class: | II |
|---|---|
| Review Category: | Tier II |
Ultrasonic Pulsed Doppler Imaging System - Procode: 90-IYN [Fed.Reg.No.:892.1550] Ultrasonic Pulsed Echo Imaging System - Procode: 90-IYO [Fed.Reg.No.:892.1560] Diagnostic Ultrasonic Transducer - Procode: 90-ITX [Fed. Reg. No.: 892.1570]
Identification of Predicate Devices:
Toshiba America Medical Systems believes that this device is substantially equivalent to the SSA-390A/PowerVision 8000, 510(k) control number K991858 and the UIDM-400A, 510(k) control number K992886.
Device Description:
The APLIO Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.
Intended Use:
The APLIO is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial) and laparoscopic.
Safety Considerations:
This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601 (applicable portions), IEC601-2-37 (Draft), the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard. This unit is similar to that of the Toshiba SSA-390A/PowerVision 8000 and engineering assessments identify no unmitigated issues of risk or safety.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2001
Toshiba America Medical Systems, Inc. % Mr. Mark Job TÜV Product Service 1775 Old Highway 8 NW Suite 104 NEW BRIGHTON MN 25112-1891
Re: K013633
Trade Name: SSA-770A, APLIO Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: 90 IYN Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: 90 IYO Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Product Code: 90 ITX Regulatory Class: Class II Dated: November 1, 2001 Received: November 5, 2001
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 SSA-770A. APLIO Diagnostic System, as described in your premarket notification:
Transducer Model Number
PST-20CT PST-25AT
2
PVT-375AT
PVT-661VT
PLT-805AT
PLT-1202S
PLT-1204AX
PET-510MB
PET-704LA
PC-20M
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
3
Page 3 - Mr. Job
promotion and advertising of your device, please contact the Office of Compliance at (301) 594promotion and advertising of your do root, preference to preference to premarket 40.59. Also, please note the regulation on entreas, "Antition on your responsibilities under the notification (21 CFR Fall 807.77). Only genel Manufacturers, International and Consumer Act may be oblamed from the Division of Binan Manatestanters, and its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancyc bogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
4
Diagnostic Ultrasound Indications For Use Form
Transducer____ System X SSA-770A Model 510(k) Number(s) _
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Harmonic | ||||||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | n | n | n | n | n | n | n | n | |||
| Abdominal | n | n | n | n | n | n | n | n | |||
| Intraoperative (Specify) | n | n | n | n | n | n | n | ||||
| Intraoperative Neurological | |||||||||||
| Pediatric | n | n | n | n | n | n | n | n | n | ||
| Small Organ (Specify) | n | n | n | n | n | n | n | n | |||
| Neonatal Cephalic | n | n | n | n | n | n | n | n | n | n | |
| Adult Cephalic | n | n | n | n | n | n | n | n | n | n | |
| Cardiac | n | n | n | n | n | n | n | n | n | n | |
| Transesophageal | n | n | n | n | n | n | n | n | n | ||
| Transrectal | n | n | n | n | n | n | n | n | |||
| Transvaginal | n | n | n | n | n | n | n | n | |||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | n | n | n | n | n | n | n | n | |||
| Laparoscopic | n | n | n | n | n | n | n | ||||
| Musculo-skeletal Superficial | n | n | n | n | n | n | n | n | |||
| Musculo-skeletal | n | n | n | n | n | n | |||||
| Conventional | |||||||||||
| Other (specify) | |||||||||||
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF
(PLEASE DO NOT WRITE BELOW THIS LINE_CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brugdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K013693
510(k) Number
RA
5
Transducer Model Number: PST-20CT 510(k) Control Number:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Harmonic | |||||||||
| Imaging) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | |
| Cardiac | P | P | P | P | P | P | P | P | P | |
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Other (specify) |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF
(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Divisio Division of Re and Radiological D 510(k) Number
6
Transducer Model Number: PST-25AT 510(k) Control Number:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Harmonic | |||||||||
| Imaging) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | |
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | P | P | P | |
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| İntravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Other (specify) |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF
(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON OTHER PAGES IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy bradshaw
510(k) Number
7
Transducer Model Number: PVT-375AT 510(k) Control Number:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Harmonic | |||||||||
| Imaging | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | P | P | ||
| Intraoperative (Specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P | P | ||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Other (specify) |
N= new indication: P = Previously Cleared by FDA: F = Added under Appendix E (LTE)
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; CHI/2D; FEI/2D, CHI/BDF; FEI/BDF
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON OTHER PAGES TE NEGDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
Division of Reprodu and Radiological Devic Prescription Use (Per 21 CFR 801.109) 510(k) Number
8
Transducer Model Number: PVT-661VT 510(k) Control Number:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | P | P | P | P | P | ||
| Transvaginal | P | P | P | P | P | P | P | P | ||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Other (specify) |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF;BDF/MDF/PED; B-TDI; M-TDI; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF
Other: Harmonic Imaging (CHI, FEI)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDEN Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brandon
(Division Sign-Of Division of Reproduct ive. Abo and Radiological Devices 510(k) Number
9
Transducer Model Number: PLT-805AT 510(k) Control Number:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Harmonic | |||||||||
| Imaging | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | P | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | P | P | P | P | P | P | P | P | ||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | P | P | P | ||
| Other (specify) |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTHER PAGES IS NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Broydon
(Division Sign-C Division of Reproductive and Radiological Devic 510(k) Number
10
Transducer Model Number: PLT-1202S 510(k) Control Number:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | P | P | P | P | P | P | P | |||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal | P | P | P | P | P | P | P | |||
| Superficial | ||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | |||
| Other (specify) |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments:
| BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI | Combined Modes: B/M; B/PWD; BDF/PWD; |
|---|---|
| ----------------------------------- | -------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Snowdon
(Division Sign-Off) Division of Reproductive, Abe lominal, and Radiological Devices 510(k) Number 33
11
Transducer Model Number: PLT-1204AX 510(k) Control Number:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal | P | P | P | P | P | P | P | |||
| Superficial | ||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | |||
| Other (specify) | ||||||||||
| N= new indication; P = Previously Cleared by FDA; | E = Added under Appendix E (LTF) | |||||||||
| Additional Comments: | Combined | Modes: | B/M: | B/PWD: | BDF/PWD: | |||||
| BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IS NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. brogdon
(Division Sign-Off)/ Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_
12
Transducer Model Number: PET-510MB 510(k) Control Number:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | P | P | P | P | P | P | P | P | ||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Other (specify) | ||||||||||
| N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF) |
y, as listed by FWS, a - Listed under Appendix II (CIT
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD;
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Prescription Use (Per 21 CFR 801.109) and Radiological Devices
Prescription Use (Per 21 CFR 801.109) and Radiological Devices
13
Transducer Model Number: PET-704LA 510(k) Control Number:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | P | P | P | P | P | P | P | |||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Other (specify) |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments:
| Combined Modes: | B/M; B/PWD; BDF/PWD; |
|---|---|
| BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI |
(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON OTHER PAGES IS NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broadrick
(Division Sign-Off)
Division of Reproductive, Abd Prescription Use (Per 21 CFR 801.109) and Radiological Devices minal 510(k) Number
14
Transducer Model Number: PC-20M 510(k) Control Number:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | P | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N=new indication; P = Previously Cleared by FDA; = Added under App
Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; Additional Comments: BDF/MDF/PWD;B-TDI; M-TDI
(PLEASE DO NOT WRITE BELOW THIS LIME CONTINUE ON OTHER PAGES IE NEFDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancie Brandon
(Division Sign-Off) Division of Reproduct and Radiological Devices 510(k) Number .