(23 days)
No
The summary does not mention AI, ML, or any related terms, and the description of the device and performance studies does not suggest the use of such technologies.
No
The device is described as a "Diagnostic Ultrasound System" intended for "ultrasound evaluation" and "imaging and analysis." It does not mention any therapeutic capabilities.
Yes
The device is explicitly named "Prosound F75 Diagnostic Ultrasound System" and its intended use is for "ultrasound evaluation" of various body parts.
No
The device description explicitly states it consists of a "mobile console" with hardware components like a keyboard, specialized controls, and a display, indicating it is a hardware system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that the Prosound F75 Diagnostic Ultrasound System is used for ultrasound evaluation of various anatomical sites within the body. It acquires, processes, and displays images based on sound waves interacting with internal tissues.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient. Its function is entirely based on non-invasive imaging of the body's internal structures.
Therefore, the device falls under the category of diagnostic imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Trans-vaginal , Trans-rectal, Gynecological, Musculo-sketal and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications.
The Prosound F75 diagnostic ultrasound system and its transducers are intended for use in diagnostic ultrasound examinations. These ultrasound applications for use include: Small Parts, Intraoperative, Abdominal, Gynecological, Cardiac, Musculo-skeletal, Transvaginal, Neonatal: Cephalic, Fetal & Peripheral Vascular.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal, Abdominal, Intra-operative (liver, pancreas, gall bladder..), Small Organ ((breast, testes & thyroid..)), Neonatal Cephalic, Cardiac, Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal Conventional, Gynecological.
Product codes
IYN, ITX, IYO
Device Description
The Prosound F75 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Trans-vaginal, Trans-rectal, Musculo-skeletal, Gynecological, Neonatal Cephalic. Small Parts-(breast, testes & thyroid..), Intra-operative- (liver, pancreas, gall bladder..).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physician
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)
Non-clinical Tests: The device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform with applicable medical device safety standards.
Clinical Tests: None Required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K041916, K992663, K043196, K012080, K963616, K003739, K060059, K032875
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
י
.
"
Model Prosound F75
510(K)
1026 KI FEB 1 7 2011
510(k) Summary of Safety and Effectiveness ・ Prepared in accordance with 21 CFR Part 807.92
| Section a): | |
|---|---|
| 1. Submitter: | Aloka Co., Ltd., 10 Fairfield Boulevard, Wallingford, CT 06492 |
| Contact Person: | Richard J. Cehovsky, RA/QA Mngr., |
| Tel: (203)269-5088 Ext. 346, Fax: 203-269-6075 | |
| Date Prepared: | 11/24/2010 |
| 2. Device Name: | Aloka Prosound F75 Diagnostic Ultrasound System |
| Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550 , 90 IYN | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90 ITX | |
| Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90 IYO | |
| 3. Marketed Device: | Aloka Alpha 10 Diagnostic Ultrasound System, K043196, (90-IYN, ITX, IYO) |
| ( A device currently in commercial distribution) | |
| 4. Device Description: | The Prosound F75 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display. |
| 5. Indications for Use: | The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Trans-vaginal , Trans-rectal, Gynecological, Musculo-sketal and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications. |
| 6. Comparison w/ Predicate Device: | The Aloka Prosound F75 is technically comparable and substantially equivalent to the current Aloka Alpha 10-(K043196). It has the same technological characteristics, key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate device. |
| Section b): | |
| 1. Non-clinical Tests: | The device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform with applicable medical device safety standards. |
| 2. Clinical Tests: | None Required. |
| 3. Conclusion: | Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effectiveness performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka Prosound F75 Diagnostic Ultrasound System and its transducers are substantially equivalent with respect to safety and effectiveness to its predicate and other currently cleared Aloka systems. |
1
New Indications for Use: There are no new indications for use. 1.3.2
Previously Cleared Indications for Use: 1.3.3
The Prosound F75 diagnostic ultrasound system and its transducers are intended for use in diagnostic ultrasound examinations. These ultrasound applications for use include: Small Parts, Intraoperative, Abdominal, Gynecological, Cardiac, Musculo-skeletal, Transvaginal, Neonatal: Cephalic, Fetal & Peripheral Vascular.
The Prosound F75 has the same indications for use as its predicate - Aloka Alpha 10- (K043196) and other market cleared systems and transducers manufactured by Aloka.
Promotional information for the Prosound F75 is provided in Appendix D of this submission.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Aloka Co., Ltd (Aloka America) % Mr. Michael S. Ogunleye 510(k) Program Manager/Medical Lead Auditor TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
FEB 1 7 2011
Re: K110207
Trade/Device Name: Aloka Prosound F75 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 14, 2011 Received: January 25, 2011
Dear Mr. Ogunleye:
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
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 Aloka Prosound F75, as described in your premarket notification: ··
Transducer Model Number
| UST-567 | UST-5411 | UST-9146T |
|---|---|---|
| UST-675P | UST-5415 | UST-9147 |
| ASU-1010 | UST-9118 | UST-52105 |
| UST-2265-2 | UST-9130 | UST-52119S |
| UST-2266-5 | UST-9133 | UST-52121S |
| UST-5293-5 | UST-9146I | UST-52124 |
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 895. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (301) 796-6881.
Sincerely Yours.
han DOK for
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
4
Indications for Use
510(K) Number (if known): Device Name:
Indications For Use:
Aloka Prosound F75
The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Trans-vaginal, Trans-rectal, Musculo-skeletal, Gynecological and Neonatal Cephalic applications.
The device is not indicated for Ophthalmic applications.
Prescription Use_ P (Part 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aushad D.K.
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110207
Page 1 of 1
5
1.3.1
Diagnostic Ultrasound Indications for Use Form Prosound F75 .
Intended 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 | ||||||||||
| (CD) | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | N | N | N | N | See Note 1 | |||||
| Abdominal | N | N | N | N | See Note 1 | |||||
| Intra-operative (specify) | N | N | N | N | See Note 1 | |||||
| Intra-operative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | N | N | N | N | See Note 1 | |||||
| Neonatal Cephalic | N | N | N | N | See Note 1 | |||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | See Note 1, 2 | ||||
| Transesophageal | ||||||||||
| Transrectal | N | N | N | N | See Note 1 | |||||
| Transvaginal | N | N | N | N | See Note 1 | |||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | See Note 1 | |||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | N | N | N | N | ||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | N | N | N | N | See Note 1 |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes: Note I- B/M, B/PWD, M/CD, B/CWD, B/CD/CWD Applications: Small Parts-(breast, testes & thyroid..), Intra-operative- (liver, pancreas, gall bladder..)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
510K K110207
6
Diagnostic Ultrasound Indications for Use Form UST-567 (K041916)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler
(CD) | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(specify) | Other (specify) |
|----------------------------------|---|---|---|-----|-----|--------------------------|----------------------|------------------------------|-----------------------|-----------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | N | N | N | | N | | | See Note 1 | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | | | See Note 1 | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | N | N | N | | N | | | See Note 1 | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other: | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: B/M, B/WD, M/CD, B/CD/PWD
Applications: Small Parts: ( breasts, testes, thyroid ... )
. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
510K K110207
7
Diagnostic Ultrasound Indications for Use Form UST-675P (K992663)
Intended 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 | ||||||||||
| (CD) | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | P | See Note 1 | |||||
| Transvaginal | P | P | P | P | See Note 1 | |||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: BM, B/PWD, M/CD, B/CD/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Mihail D. O'Brien
(Division Sign-Off)
510K K110207
8
Diagnostic Ultrasound Indications for Use Form ASU-1010 (K043196)
Intended 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 | ||||||||||
| (CD) | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | P | P | See Note 1 | |||||
| Abdominal | P | P | P | P | See Note 1 | |||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal- | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | P | P | P | P | See Note 1 |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: B/M, B/PWD, M/CD, B/CD/PWD
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
No br. 10 Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K Kilox22
9
Diagnostic Ultrasound Indications for Use Form UST-2265-2 (K012080)
Intended 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 | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | ||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Division of Alakological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K110267
45
10
Diagnostic Ultrasound Indications for Use Form UST-2266-5 (K963616)
Intended 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 | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | ||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110267
11
Diagnostic Ultrasound Indications for Use Form UST-5293-5 (K003739)
Intended 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 | ||||||||||
| (CD) | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | See Note 1, 2 | ||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: BM, BPWD, MCD, B/CD/PWD, Note 2: B/CWD, B/CD/CWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
510K. K110207
12
Diagnostic Ultrasound Indications for Use Form UST-5411 (K043196)
Intended 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 | |||||||||||
| (CD) | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | P | P | P | P | See Note 1 | ||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | See Note 1 | ||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | P | P | P | P | See Note 1 | ||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: B/M, B/PWD, M/CD, B/CD/PWD
Applications: Small Parts: (breasts, testes, thyroid ... )
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Preseription Use (Per 21 CFR 801.109)
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.
510(K)
Diagnostic Ultrasound Indications for Use Form UST-5415 (K043196)
Intended 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 | |||||||||||
| (CD) | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | N | N | N | N | See Note 1 | ||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | N | N | N | See Note 1 | ||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | N | N | N | N | See Note 1 | ||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: BM, BIPWD, MICD, BICD/PWD
Applications: Small Parts: (breasts, testes, thyroid....)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
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Diagnostic Ultrasound Indications for Use Form UST-9118 (K992663)
Intended 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 | ||||||||||
| (CD) | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | P | P | See Note 1 | |||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | See Note 1 | |||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | P | P | P | P | See Note 1 |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: B/M, B/PWD, M/CD, B/CD/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
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510K K110267
50
15
Diagnostic Ultrasound Indications for Use Form UST-9130 (K043196)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | ||||||||||
| (CD) | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | P | P | See Note 1 | |||||
| Abdominal | P | P | P | P | See Note 1 | |||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | P | P | P | P | See Note 1 |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: B/M, B/PWD, M/CD, B/CD/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
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510K K110207
16
Diagnostic Ultrasound Indications for Use Form UST-9133 (K060059)
Intended 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 | |||||||||||
| (CD) | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | P | P | P | P | See Note 1 | ||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | P | P | P | P | See Note 1 | ||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretbral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes-Note 1: BM, B/PWD, M/CD, B/CD/PWD.
Applications: Intra-operative- (liver, pancreas, gall bladder..)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
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17
Diagnostic Ultrasound Indications for Use Form UST-91461 (K963616)
Intended 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 | ||||||||||
| (CD) | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | N | N | N | N | See Note 1 | |||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes-Note 1: BM, B/PWD, M/CD, B/CD/PWD.
Applications: Intra-operative- (liver, pancreas, gall bladder.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Division Sign-Off
510K. K115207
18
ﺍ
Diagnostic Ultrasound Indications for Use Form UST-9146T (K963616)
Intended 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 | |||||||||||
| (CD) | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | N | N | N | N | See Note 1 | ||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: BM, B/PWD, M/CD, B/CD/PWD.
Applications: Intra-operative- (liver, pancreas, gall bladder.).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Mh Dork
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19
Diagnostic Ultrasound Indications for Use Form UST-9147 (K043196)
Intended 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 | ||||||||||
| (CD) | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | N | N | N | N | See Note 1 | |||||
| Abdominal | N | N | N | N | See Note 1 | |||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: Gynecological | N | N | N | N | See Note 1 |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes: BM, B/PWD, M/CD, B/CD/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
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20
Diagnostic Ultrasound Indications for Use Form UST-52105 (K032875
Intended 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 | ||||||||||
| (CD) | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | See Note 1, 2 | ||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: B/M, B/PWD, M/CD, B/CD/PWD & Note 2: B/CWD, B/CD/CWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
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510K K110207 56
56
21
Diagnostic Ultrasound Indications for Use Form UST-52119S (K003739)
Intended 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 | |||||||||||
| (CD) | Amplitude | ||||||||||
| Velocity | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac, Pediatric | N | N | N | N | N | N | See Note 1, 2 | ||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: BM, BPWD, MCD, B/CDPWD, & Note 2: B/CWD, B/CD/CWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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22
Diagnostic Ultrasound Indications for Use Form UST-521218 (K003739)
Intended 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 | ||||||||||
| (CD) | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (Pediatric) | N | N | N | N | N | N | See Note 1, 2 | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: BM, B/PWD, MCD, B/CD/PWD & Note 2: B/CWD, B/CD/CWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
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510K. K110207
દક
23
1
Diagnostic Ultrasound Indications for Use Form UST-52124 (K032875)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | ||||||||||
| (CD) | Amplitude | |||||||||
| Velocity | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | Note 1, 2 | ||||
| Adult Cephalic | ||||||||||
| Cardiac (Neonatal) | N | N | N | N | N | Note 1, 2 | ||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other: |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined includes Note 1: BM, BPWD, MCD, B/CDPWD, Note 2: B/CWD, B/CD/CWD
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59 ·
(Division Sign-Off)
(Uivision of Radiological Devices Division of Radiological Devices
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ica of In Vitro Diagnostic Device
510K K110207