The following data is part of a premarket notification filed by Konica Minolta, Inc. with the FDA for Skr 3000.
Device ID | K171716 |
510k Number | K171716 |
Device Name: | SKR 3000 |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | Konica Minolta, Inc. 1 Sakura-machi Hino-shi, JP 191-8511 |
Contact | Tsutomu Fukui |
Correspondent | Russell D. Munves Storch Amini & Munves PC 140 East 45th Street, 25th Floor New York, NY 10017 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-06-09 |
Decision Date | 2017-08-25 |