The following data is part of a premarket notification filed by Perkinelmer, Inc. with the FDA for Perkinelmer Xrd 1622 Ap3 Med Flat Panel Detector.
| Device ID | K122495 |
| 510k Number | K122495 |
| Device Name: | PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis, IN 46236 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis, IN 46236 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-16 |
| Decision Date | 2012-11-28 |
| Summary: | summary |