The following data is part of a premarket notification filed by Carl Zeiss Meditec, Inc. with the FDA for Intrabeam System With Intrabeam Spherical Applicators.
| Device ID | K121653 |
| 510k Number | K121653 |
| Device Name: | INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS |
| Classification | System, Therapeutic, X-ray |
| Applicant | CARL ZEISS MEDITEC, INC. 5160 HACIENDA DRIVE Dublin, CA 95030 |
| Contact | Sarah Harrington |
| Correspondent | Sarah Harrington CARL ZEISS MEDITEC, INC. 5160 HACIENDA DRIVE Dublin, CA 95030 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-05 |
| Decision Date | 2012-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049539101631 | K121653 | 000 |
| 04049539101624 | K121653 | 000 |
| 04049539101617 | K121653 | 000 |
| 04049539101600 | K121653 | 000 |
| 04049539101594 | K121653 | 000 |
| 04049539101587 | K121653 | 000 |
| 04049539101570 | K121653 | 000 |
| 04049539101563 | K121653 | 000 |