The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fdr D-evo Ii Flat Panel Detector System.
| Device ID | K142003 |
| 510k Number | K142003 |
| Device Name: | FDR D-EVO II FLAT PANEL DETECTOR SYSTEM |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
| Contact | Katherine Y Choi |
| Correspondent | Katherine Y Choi FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-23 |
| Decision Date | 2014-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410355420 | K142003 | 000 |
| 04547410308518 | K142003 | 000 |
| 04547410308501 | K142003 | 000 |
| 04547410308211 | K142003 | 000 |
| 04547410305067 | K142003 | 000 |
| 04547410290899 | K142003 | 000 |
| 04547410290851 | K142003 | 000 |
| 04547410289077 | K142003 | 000 |
| 04547410289053 | K142003 | 000 |
| 04547410289039 | K142003 | 000 |
| 04547410289015 | K142003 | 000 |
| 04547410288995 | K142003 | 000 |
| 04547410288971 | K142003 | 000 |
| 04547410288957 | K142003 | 000 |
| 04547410288902 | K142003 | 000 |
| 04547410288858 | K142003 | 000 |
| 04547410308525 | K142003 | 000 |
| 04547410308532 | K142003 | 000 |
| 04547410448214 | K142003 | 000 |
| 04547410438352 | K142003 | 000 |
| 04547410431599 | K142003 | 000 |
| 04547410361377 | K142003 | 000 |
| 04547410361360 | K142003 | 000 |
| 04547410361353 | K142003 | 000 |
| 04547410361346 | K142003 | 000 |
| 04547410355406 | K142003 | 000 |
| 04547410335286 | K142003 | 000 |
| 04547410333374 | K142003 | 000 |
| 04547410319385 | K142003 | 000 |
| 04547410309324 | K142003 | 000 |
| 04547410309294 | K142003 | 000 |
| 04547410309249 | K142003 | 000 |
| 04547410308549 | K142003 | 000 |
| 04547410288803 | K142003 | 000 |