FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
APPLICATORS FOR AFTERLOADING BRACHYTHERAPY
K Number: K082530
·
Decision Oct 30, 2008
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
206
Applicant Total
4
Review Days
58
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- APPLICATORS FOR AFTERLOADING BRACHYTHERAPY
- K Number
- K082530
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.5700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Isodose Control B.V.
- Date Received
- September 2, 2008
- Decision Date
- October 30, 2008
- Product Code
- JAQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAQ), ordered by most recent decision date.
MAASTRO Rectal Applicator Set
FDA 510(k)
FDA Class 2
·Radiology
Rectal Applicator
FDA 510(k)
FDA Class 2
·Radiology
Guided Aarhus Applicator Set
FDA 510(k)
FDA Class 2
·Radiology
CT/ MR Tandem and Ovoid Set
FDA 510(k)
FDA Class 2
·Radiology
Intracavitary/Interstitial System
FDA 510(k)
FDA Class 2
·Radiology
Titanium Flexible Geometry FSD Applicator Set (GM11013400)
FDA 510(k)
FDA Class 2
·Radiology