Submission Details
| 510(k) Number | K001711 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 05, 2000 |
| Decision Date | June 20, 2000 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1
Jun 2000
Decision
15d
Days
Class 2
Risk
About This 510(k) Submission
K001711 is an FDA 510(k) clearance for the M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Agilent Technologies, Inc. (Andover, US). The FDA issued a Cleared decision on June 20, 2000, 15 days after receiving the submission on June 5, 2000. 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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