Submission Details
| 510(k) Number | K920393 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 30, 1992 |
| Decision Date | April 06, 1992 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
Cleared
Traditional
MU125M MOBILE X-RAY SYSTEM
Apr 1992
Decision
67d
Days
Class 2
Risk
About This 510(k) Submission
K920393 is an FDA 510(k) clearance for the MU125M MOBILE X-RAY SYSTEM, a System, X-ray, Photofluorographic (Class II — Special Controls, product code IZG), submitted by Shimadzu Medical Systems (Gardena, US). The FDA issued a Cleared decision on April 6, 1992, 67 days after receiving the submission on January 30, 1992. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1730.
Device Classification
| Product Code | IZG — System, X-ray, Photofluorographic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1730 |
Manufacturer
Similar Devices — IZG System, X-ray, Photofluorographic
K960082 · Spinal Specialties, Inc.
· Mar 1996
K960146 · GE Medical Systems
· Feb 1996
K913436 · Brotherston/Pxi
· Nov 1992
K910503 · B. Braun of America, Inc.
· Oct 1991
K903808 · Advanced Med/Surg, Inc.
· Jan 1991
K892659 · Oldelft Corp. of America
· Nov 1989
More from Shimadzu Medical Systems
View all
K082224
· ITX · Dec 2008
K071287
· ITX · Jan 2008
K071289
· ITX · Jan 2008
K071291
· ITX · Jan 2008
K061643
· IYN · Jul 2006