Octostop Compensating Filters
FDA 510(k) K940306 · Octostop, Inc.
510(k) numberK940306
Submission
- Device name
- Octostop Compensating Filters
- Applicant
- Octostop, Inc.
Montreal, Qc., CA - Received
- January 12, 1994
- Decision date
- September 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…KPR · Traditional | DRTECH Corporation | 09/08/2026SE |
| K260488 | MULTIX Impact; MULTIX Impact CKPR · Traditional | Siemens Medical Solutions USA, Inc. | 08/31/2026SE |
| K260481 | GC85AKPR · Traditional | Samsung Electronics Co., Ltd. | 08/27/2026SE |
| K260482 | DRE DuoKPR · Traditional | Jpi Healthcare Co, Ltd. | 06/15/2026SE |
| K253446 | AeroDR TX c02KPR · Traditional | Dk Medical Systems Co., Ltd. | 04/10/2026SE |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…KPR · Traditional | Carestream Health | 01/20/2026SE |
| K252000 | uDR Arria & uDR ArisKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 11/26/2025SE |
| K251167 | uDR Aurora CXKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 09/19/2025SE |
| K250788 | Definium Tempo SelectKPR · Traditional | Ge Hualun Medical Systems Co. , Ltd. | 08/28/2025SE |
| K250790 | Innovision-DxiiKPR · Traditional | Dk Medical Systems Co., Ltd. | 08/01/2025SE |
More from Dk Medical Systems Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K972766 | Pivoting Compensating Filters for the HeadKPR · Traditional | 08/14/1997SE |
| K963941 | The Pharaoh Compensating FilterKPR · Traditional | 11/27/1996SE |
| K953246 | OctorollKXH · Traditional | 09/29/1995SE |
| K952871 | Ridges PlusKPR · Traditional | 07/20/1995SE |
| K942916 | Octopaque UniversalIXQ · Traditional | 09/08/1994SE |
| K935444 | Octostop(R) Chair (New ModelIXR · Traditional | 09/02/1994SE |
| K930124 | Variant of Octostop and OctopaqueKXH · Traditional | 02/09/1994SE |
| K930357 | Accessory to Universal OctopaqueKXH · Traditional | 07/13/1993SE |
| K926069 | Wrist TractionKPR · Traditional | 01/21/1993SE |
| K913711 | Gentle SlopeKPR · Traditional | 10/14/1992SE |
Questions and answers
When was Octostop Compensating Filters cleared by the FDA?
Octostop Compensating Filters (K940306) received a 510(k) decision of Substantially Equivalent on September 6, 1994, 237 days after the submission was received.
What is the product code of K940306?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.