NEUTRON THERAPY SYSTEM
FDA 510(k) clearance K063691 · decided 2007-01-31
Clearance details
- K-number
- K063691
- Device name
- NEUTRON THERAPY SYSTEM
- Applicant
- Northern Illinois Univ. Outreach
- Decision
- Substantially Equivalent
- Date received
- 2006-12-12
- Decision date
- 2007-01-31
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- IWL
- Device class
- 2
- Regulation number
- 892.5300
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Northern Illinois Univ. Outreach
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS (K852804) | Medcyc. Corp. | 1985-10-15 |
| ISOCENTRIC NEUTRON THERAPY SYSTEMS (K812337) | The Cyclotron Corp. | 1981-10-02 |
| MODEL 4100 14 MEV NEUTRON GEN. THERAPY (K811778) | The Cyclotron Corp. | 1981-07-23 |
Recalls involving this device
No recalls on record reference this clearance.