Submission Details
| 510(k) Number | K940285 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 10, 1994 |
| Decision Date | April 29, 1994 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
K940285 - ACUSON PICTURE ARCHIVING & COMMUNICATION SYSTEM MODIFICATION
(FDA 510(k) Clearance)
Apr 1994
Decision
109d
Days
Class 2
Risk
K940285 is an FDA 510(k) clearance for the ACUSON PICTURE ARCHIVING & COMMUNICATION SYSTEM MODIFICATION, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on April 29, 1994, 109 days after receiving the submission on January 10, 1994. 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 |
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