MODEL 4100 14 MEV NEUTRON GEN. THERAPY
FDA 510(k) clearance K811778 · decided 1981-07-23
Clearance details
- K-number
- K811778
- Device name
- MODEL 4100 14 MEV NEUTRON GEN. THERAPY
- Applicant
- The Cyclotron Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-06-23
- Decision date
- 1981-07-23
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- IWL
- Device class
- 2
- Regulation number
- 892.5300
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NEUTRON THERAPY SYSTEM (K063691) | Northern Illinois Univ. Outreach | 2007-01-31 |
| MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS (K852804) | Medcyc. Corp. | 1985-10-15 |
| ISOCENTRIC NEUTRON THERAPY SYSTEMS (K812337) | The Cyclotron Corp. | 1981-10-02 |
Recalls involving this device
No recalls on record reference this clearance.