Submission Details
| 510(k) Number | K963941 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 01, 1996 |
| Decision Date | November 27, 1996 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
Cleared
Traditional
THE PHARAOH COMPENSATING FILTER
Nov 1996
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K963941 is an FDA 510(k) clearance for the THE PHARAOH COMPENSATING FILTER, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Octostop, Inc. (Montreal, Qc., CA). The FDA issued a Cleared decision on November 27, 1996, 57 days after receiving the submission on October 1, 1996. 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
Similar Devices — KPR System, X-ray, Stationary
All 353
K250954 · Carestream Health
· Jan 2026
K252000 · Shanghai United Imaging Healthcare Co., Ltd.
· Nov 2025
K251167 · Shanghai United Imaging Healthcare Co., Ltd.
· Sep 2025
K250788 · Ge Hualun Medical Systems Co. , Ltd.
· Aug 2025
K250790 · Dk Medical Systems Co., Ltd.
· Aug 2025
K250738 · Siemens Medical Solutions
· Jul 2025
More from Octostop, Inc.
View all
K972766
· KPR · Aug 1997
K953246
· KXH · Sep 1995
K952871
· KPR · Jul 1995
K942916
· IXQ · Sep 1994
K940306
· KPR · Sep 1994