K780993 is an FDA 510(k) clearance for the ULTRASOUND IMAGING SYSTEM. This device is classified as a Retractor (Class I - General Controls, product code GAD).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1978, 57 days after receiving the submission on June 14, 1978.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K780993 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1978 |
| Decision Date | August 10, 1978 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | GAD — Retractor |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |