The following data is part of a premarket notification filed by Medison Radiology Systems, Inc. with the FDA for Cordless Compact Mobile X-ray System.
Device ID | K002685 |
510k Number | K002685 |
Device Name: | CORDLESS COMPACT MOBILE X-RAY SYSTEM |
Classification | System, X-ray, Mobile |
Applicant | MEDISON RADIOLOGY SYSTEMS, INC. 151 SOUTH PFINGSTEN RD. Deerfield,, IL 60015 |
Contact | John W Lee |
Correspondent | John W Lee MEDISON RADIOLOGY SYSTEMS, INC. 151 SOUTH PFINGSTEN RD. Deerfield,, IL 60015 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-28 |
Decision Date | 2000-09-15 |