CENTRALITE BACKPOINTER
FDA 510(k) clearance K954414 · decided 1995-10-23
Clearance details
- K-number
- K954414
- Device name
- CENTRALITE BACKPOINTER
- Applicant
- Diacor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-09-21
- Decision date
- 1995-10-23
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- IWE
- Device class
- 1
- Regulation number
- 892.5780
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Salt Lake City, UT, 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 |
|---|---|---|
| CT Sim Laser System (K152303) | Gammex, Inc. | 2015-09-11 |
| DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (K973162) | Hogan & Hartson | 1997-11-20 |
| GREEN TEC-2100 (K955236) | Medtec, Inc. | 1996-05-24 |
| TEC-2110 GREEN LASER MODEL MT-HNG (K950293) | Medtec, Inc. | 1995-08-18 |
| CENTRALITE(R)-DLL SERIES (K950112) | Diacor, Inc. | 1995-08-16 |
| MED-TEC STRING RETICLE TRAY (K951601) | Medtec, Inc. | 1995-05-11 |
| HP BACK POINTER SYSTEM (K943802) | Medtec, Inc. | 1994-12-07 |
| LASER ALIGNMENT TOOL (K943381) | Philips Medical Systems North America, Inc. | 1994-08-09 |
| TEC 2101 (MODEL MT-HPLGD) (K941169) | Medtec, Inc. | 1994-07-18 |
| TEC 2100 (MODEL MT-LPLGD) (K935760) | Medtec, Inc. | 1994-01-25 |
| RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM (K934519) | Medtec, Inc. | 1993-12-13 |
| AZ 92 (K931974) | A2j, Inc. | 1993-10-08 |
Recalls involving this device
No recalls on record reference this clearance.