I2C
FDA 510(k) clearance K132847 · decided 2013-11-20
Clearance details
- K-number
- K132847
- Device name
- I2C
- Applicant
- Ion Beam Applications S.A.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-11
- Decision date
- 2013-11-20
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- LHN
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Philadelphia, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged pa recall (Z-0836-2015) | Ion Beam Applications S.A. | 2014-12-19 |