The following data is part of a premarket notification filed by Ge Healthcare Technologies with the FDA for Ge Healthcare Insta Trak 3500plus/ Fluoro Trak 9800 Plus System With Axcess Bone Pin, Model Part # 1006955.
| Device ID | K051734 |
| 510k Number | K051734 |
| Device Name: | GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | GE HEALTHCARE TECHNOLOGIES 439 SOUTH UNION STREET, 3RD FL Lawrence, MA 01843 |
| Contact | Raj Kasbekar |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-06-28 |
| Decision Date | 2005-11-23 |
| Summary: | summary |