Submission Details
| 510(k) Number | K953246 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 11, 1995 |
| Decision Date | September 29, 1995 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
OCTOROLL
Sep 1995
Decision
80d
Days
Class 1
Risk
About This 510(k) Submission
K953246 is an FDA 510(k) clearance for the OCTOROLL, a Cradle, Patient, Radiologic (Class I — General Controls, product code KXH), submitted by Octostop, Inc. (Montreal, H2x2t7, CA). The FDA issued a Cleared decision on September 29, 1995, 80 days after receiving the submission on July 11, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1830.
Device Classification
| Product Code | KXH — Cradle, Patient, Radiologic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 892.1830 |
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