JOPClass II
Transducer, Ultrasonic
21 CFR 870.2880 / Cardiovascular
JOP is the FDA product code for Transducer, Ultrasonic, a class II device type, regulated under 21 CFR 870.2880. As of , FDA records hold 72 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- JOP
- Device name
- Transducer, Ultrasonic
- Regulation
- 21 CFR 870.2880
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 72
- Ingested recalls
- 1
Clearances, product code JOP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1984 | 10 |
| 1985 | 11 |
| 1986 | 11 |
| 1987 | 12 |
| 1988 | 5 |
| 1989 | 4 |
| 1990 | 1 |
| 1991 | 5 |
| 1994 | 1 |
| 1995 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2007 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2024 | 2 |
Applicants with the most clearances
Product code JOP| Applicant | Clearances |
|---|---|
| Advanced Technology Laboratories, Inc. | 7 |
| Acuson Computed Sonography | 6 |
| GE Medical Systems Information Technologies, Inc. | 3 |
| Imex Medical Systems, Inc. | 3 |
| Interspec, Inc. | 3 |
| Johnson & Johnson Professionals, Inc. | 3 |
| Koven Technology, Inc. | 3 |
| Applied Biometrics, Inc. | 2 |
| Ausonics Pty, Ltd. | 2 |
| Biosound, Inc. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
