Submission Details
| 510(k) Number | K872317 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 17, 1987 |
| Decision Date | August 12, 1987 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
Cleared
Traditional
BC 1800 FINGER POSITIONER
Aug 1987
Decision
56d
Days
Class 2
Risk
About This 510(k) Submission
K872317 is an FDA 510(k) clearance for the BC 1800 FINGER POSITIONER, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on August 12, 1987, 56 days after receiving the submission on June 17, 1987. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.
Device Classification
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1680 |
Manufacturer
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