JAQClass II
System, Applicator, Radionuclide, Remote-Controlled
21 CFR 892.5700 / Radiology
JAQ is the FDA product code for System, Applicator, Radionuclide, Remote-Controlled, a class II device type, regulated under 21 CFR 892.5700. As of , FDA records hold 208 510(k) clearances under this code, the most recent dated , and 52 recalls.
Classification record
- Product code
- JAQ
- Device name
- System, Applicator, Radionuclide, Remote-Controlled
- Regulation
- 21 CFR 892.5700
- Device class
- Class II
- Review panel
- Radiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 208
- Ingested recalls
- 52
Clearances, product code JAQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1981 | 1 |
| 1983 | 1 |
| 1984 | 2 |
| 1985 | 1 |
| 1986 | 3 |
| 1988 | 1 |
| 1989 | 4 |
| 1990 | 3 |
| 1991 | 1 |
| 1992 | 8 |
| 1993 | 2 |
| 1995 | 3 |
| 1996 | 4 |
| 1997 | 1 |
| 1998 | 5 |
| 1999 | 6 |
| 2000 | 6 |
| 2001 | 2 |
| 2002 | 7 |
| 2003 | 7 |
| 2004 | 7 |
| 2005 | 6 |
| 2006 | 13 |
| 2007 | 11 |
| 2008 | 10 |
| 2009 | 10 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 7 |
| 2013 | 6 |
| 2014 | 7 |
| 2015 | 11 |
| 2016 | 6 |
| 2017 | 7 |
| 2018 | 7 |
| 2019 | 2 |
| 2020 | 4 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 10 |
| 2025 | 6 |
| 2026 | 2 |
Applicants with the most clearances
Product code JAQ| Applicant | Clearances |
|---|---|
| Varian Medical Systems, Inc. | 59 |
| Nucletron BV | 35 |
| Mick Radio-Nuclear Instruments, Inc. | 22 |
| Nucletron-Oldelft Corp. | 7 |
| Alpha Omega Services Inc | 6 |
| Senorx, Inc. | 5 |
| Varian Assoc., Inc. | 5 |
| Cianna Medical, Inc. | 4 |
| Omnitron Intl., Inc. | 4 |
| Proxima Therapeutics, Inc. | 4 |
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.
