Submission Details
| 510(k) Number | K973556 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 19, 1997 |
| Decision Date | April 24, 1998 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
Cleared
Traditional
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000
Apr 1998
Decision
217d
Days
Class 2
Risk
About This 510(k) Submission
K973556 is an FDA 510(k) clearance for the IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Imex Medical Systems, Inc. (Golden, US). The FDA issued a Cleared decision on April 24, 1998, 217 days after receiving the submission on September 19, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.
Device Classification
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1550 |
Manufacturer
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