INTRABEAM SYSTEM
FDA 510(k) clearance K051055 · decided 2005-05-23
Clearance details
- K-number
- K051055
- Device name
- INTRABEAM SYSTEM
- Applicant
- Carl Zeiss Surgical GmbH
- Decision
- Substantially Equivalent
- Date received
- 2005-04-26
- Decision date
- 2005-05-23
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- JAD
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Car recall (Z-2989-2011) | Carl Zeiss Meditec, Inc. | 2011-08-10 |