Submission Details
| 510(k) Number | K912893 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 1991 |
| Decision Date | November 05, 1991 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
Cleared
Traditional
ORTHOPANTOMOGRAPH 100
Nov 1991
Decision
127d
Days
Class 2
Risk
About This 510(k) Submission
K912893 is an FDA 510(k) clearance for the ORTHOPANTOMOGRAPH 100, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Instrumentarium Corp. (Finland, FI). The FDA issued a Cleared decision on November 5, 1991, 127 days after receiving the submission on July 1, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.
Device Classification
| Product Code | EHD — Unit, X-ray, Extraoral With Timer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.1800 |
Manufacturer
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