(10 days)
No
The summary does not mention AI, ML, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
Explanation: The device is described as a "Diagnostic Ultrasound System" intended for "fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular and, musculo-skeletal (both conventional and superficial)" studies, indicating it is used for diagnosis, not therapy.
Yes
The device description explicitly states, "The FAMIO SSA-530A Diagnostic Ultrasound System is a mobile system."
No
The device description explicitly states it is a "Diagnostic Ultrasound System" and employs "probes," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to analyze these samples outside of the body.
- FAMIO SSA-530A Function: The description clearly states that the FAMIO SSA-530A is a Diagnostic Ultrasound System. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. This is a non-invasive procedure performed on the patient's body, not on a sample taken from the body.
- Intended Use: The intended uses listed (fetal, abdominal, cardiac, etc.) are all applications of medical imaging performed directly on the patient.
Therefore, based on the provided information, the FAMIO SSA-530A is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FAMIO SSA-530A is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular and, musculo-skeletal (both conventional and superficial).
Product codes
90-IYO, 90-ITX
Device Description
The FAMIO SSA-530A Diagnostic 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 and convex array with a frequency range of approximately 3.75MHz to 12MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic Pulsed Echo
Anatomical Site
fetal, abdominal, intraoperative, pediatric, small organs (thyroid, parathyroid, breast, scrotum, and penis), neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular, musculo-skeletal (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)
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
JUN 17 2005
Image /page/0/Picture/1 description: The image shows the text 'K 051500' in a handwritten style. The letter 'K' is on the left, followed by the numbers '051500'. The text appears to be written with a dark ink or marker on a white background. The handwriting is somewhat stylized, with the numbers having a slightly rounded appearance.
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, Sr. Manager of Regulatory Affairs |
| Telephone No.: | (714) 730-5000 |
| Device Proprietary Name: | SSA-530A, FAMIO |
|---|---|
| Common Name: | Diagnostic Ultrasound System |
Classification:
Regulatory Class: II Review Category: Tier II
Ultrasonic Pulsed Echo Imaging System - Product Code: 90-IYO [Fed.Reg.No.:892.1560] Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [Fed. Reg. No.: 892.1570]
Identification of Predicate Devices:
Toshiba America Medical Systems believes that this device is substantially equivalent to:
Device Description:
The FAMIO SSA-530A Diagnostic 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 and convex array with a frequency range of approximately 3.75MHz to 12MHz.
Intended Use:
The FAMIO SSA-530A is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular and, musculo-skeletal (both conventional and superficial).
Safety Considerations:
This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC60601-2-37 (applicable portions), and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2005
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K051500
Trade Name: FAMIO Diagnostic Ultrasound System, Model SSA-530A Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: IYO and ITX Dated: June 4, 2005 Received: June 7, 2005
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 FAMIO Diagnostic Ultrasound System, Model SSA-530A, as described in your premarket notification:
Transducer Model Number
| PVQ-375A | PVQ-662A |
|---|---|
| PVQ-641V | PLF-308P |
| PLQ-805A | PVQ-381A |
| PLQ-1203A |
2
Page 2 - Mr. Job
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 r may or subject to out and are and 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 Orth 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 (301) 443-6597 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 Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
System X_ Transducer___ Model_________________________________________________________________________________________________________________________________________________________________________ 510(k) Number(s)
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | P | ||||||
| W | |||||||||
| D | C | ||||||||
| W | |||||||||
| D | Color | ||||||||
| Doppler | Amplitude | ||||||||
| Doppler | Color | ||||||||
| Velocity | |||||||||
| Imaging | Combined | ||||||||
| (Specify) | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | |||||||||
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | |||||
| Abdominal | N | N | N | N | |||||
| Intraoperative (Specify)** | N | N | - | N | |||||
| Intraoperative Neurological | |||||||||
| Pediatric | N | N | N | N | |||||
| Small Organ (Specify)*** | N | N | N | ||||||
| Neonatal Cephalic | N | N | N | ||||||
| Adult Cephalic | |||||||||
| Cardiac | N | N | N | N | |||||
| Transesophageal | |||||||||
| Transrectal | N | N | N | ||||||
| Transvaginal | N | N | N | ||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | N | N | N | ||||||
| Laparoscopic | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | N | N | N | ||||||
| Musculo-skeletal | |||||||||
| Conventional | N | N | N |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments:
| | A C A B A B OFFICE
September of program of the control of
| I issue Harmonic Imaging does not use contrast agents |
|---|
| ----- |
| ** |
| *** |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc Brogdon
(Division Sign-Off) Presion of Reproducti an Dadiological Devic 5 (O(k) Number
4
Transducer X System _ PVQ-375A _ Model
510(k) Number(s)
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | P | C | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Color | ||||||||
| Velocity | |||||||||
| Imaging | Combined | ||||||||
| (Specify) | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging* | |||||||||
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | |||||
| Abdominal | N | N | N | N | |||||
| Intraoperative (Specify) | |||||||||
| Intraoperative Neurological | |||||||||
| Pediatric | N | N | N | N | |||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | |||||||||
| Laparoscopic | |||||||||
| Musculo-skeletal Superficial | |||||||||
| Musculo-skeletal | |||||||||
| Conventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments:
- Tissue Harmonic Imaging does not use contrast agents
(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 L. Brogdon
(Division Sign-Off) Pinston of Reproductive, Abdominal. and and dogical Devices 5)Olk, Number _
5
Transducer_X System_ PVQ-641V Model 510(k) Number(s)
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | P | |||||||
| W | ||||||||||
| D | C | |||||||||
| W | ||||||||||
| D | Color | |||||||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Tissue | |||||||||
| Harmonic | ||||||||||
| Imaging | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | N | N | N | |||||||
| Transvaginal | N | N | N | |||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M
Additional Comments: Combined Modes: B/M
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Higdon
(Division Sign-Off) / Division of Reproductive, Ab minal. and Radiological Devices 510(k) Number _
6
Transducer_X System _ PLQ-805A______________________________________________________________________________________________________________________________________________________________________ Model_ 510(k) Number(s)
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | P | ||||||
| W | |||||||||
| D | C | ||||||||
| W | |||||||||
| D | Color | ||||||||
| Doppler | Amplitude | ||||||||
| Doppler | Color | ||||||||
| Velocity | |||||||||
| Imaging | Combined | ||||||||
| (Specify) | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (Specify) | |||||||||
| Intraoperative Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | N | N | N | ||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | N | N | N | ||||||
| Laparoscopic | |||||||||
| Musculo-skeletal Superficial | N | N | N | ||||||
| Musculo-skeletal | N | N | N | ||||||
| Conventional | |||||||||
| N= new indication; | P = Previously Cleared by FDA; | E = Added under Appendix E (LTF) |
Combined Modes: B/M Additional Comments:
(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, Abdominal, and Radiological Devices 510(k) Number _
7
System _ Transducer X PLQ-1203A____________________________________________________________________________________________________________________________________________________________________ Model_ 510(k) Number(s)
| Clinical Application | B | M | P | C | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Tissue Harmonic Imaging |
|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (Specify) | |||||||||
| Intraoperative Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | N | N | N | N | |||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | N | N | N | ||||||
| Laparoscopic | |||||||||
| Musculo-skeletal Superficial | N | N | N | ||||||
| Musculo-skeletal | N | N | N | ||||||
| Conventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M;
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED)
Company Concurrence of CDRUL - Office of Daving Flool on AC DET Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broydon
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
8
System _ Transducer_X PVQ-662A_ Model_ 510(k) Number(s)
510(k) Number(s)
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | P | |||||||
| W | |||||||||
| D | C | ||||||||
| W | |||||||||
| D | Color | ||||||||
| Doppler | Amplitude | ||||||||
| Doppler | Color | ||||||||
| Velocity | |||||||||
| Imaging | Combined | ||||||||
| (Specify) | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | N | N | N | ||||||
| Intraoperative (Specify) | |||||||||
| Intraoperative Neurological | |||||||||
| Pediatric | N | N | N | ||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | N | N | N | ||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | |||||||||
| Laparoscopic | |||||||||
| Musculo-skeletal Superficial | |||||||||
| Musculo-skeletal | |||||||||
| Conventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Choagdon
(Division Sign-Off) (Division Sign-on)
Division of Reproductive, Abdominal, Division of Roprobection of Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
9
Transducer X System _______________________________________________________________________________________________________________________________________________________________________ Model________________________________________________________________________________________________________________________________________________________________________ PLF-308P 510(k) Number(s)
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | P | |||||||
| W | |||||||||
| D | C | ||||||||
| W | |||||||||
| D | Color | ||||||||
| Doppler | Amplitude | ||||||||
| Doppler | Color | ||||||||
| Velocity | |||||||||
| Imaging | Combined | ||||||||
| (Specify) | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | N | N | N | ||||||
| Intraoperative (Specify) | N | N | N | ||||||
| Intraoperative | |||||||||
| Neurological | |||||||||
| Pediatric | N | N | N | ||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | |||||||||
| Laparoscopic | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Musculo-skeletal | |||||||||
| Conventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED)
Nancy Brogdon
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number -
10
System _ Transducer X Model_ PVQ-381A_ 510(k) Number(s)
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | P | ||||||
| W | |||||||||
| D | C | ||||||||
| W | |||||||||
| D | Color | ||||||||
| Doppler | Amplitude | ||||||||
| Doppler | Color | ||||||||
| Velocity | |||||||||
| Imaging | Combined | ||||||||
| (Specify) | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging* | |||||||||
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | |||||
| Abdominal | N | N | N | N | |||||
| Intraoperative (Specify) | - | ||||||||
| Intraoperative Neurological | |||||||||
| Pediatric | N | N | N | N | |||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | N | N | N | N | |||||
| Transesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | |||||||||
| Laparoscopic | |||||||||
| Musculo-skeletal Superficial | |||||||||
| Musculo-skeletal | |||||||||
| Conventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: ___ Combined Modes: B/M
关 Tissue Harmonic Imaging does not use contrast agents
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off) (Division Sign-Oil)
Division of Reproductive, Abdominal.
Division of Reproductive, Abdominal. Division of Ropress
and Radiological Devices and number -----