Accessory to Universal Octopaque
FDA 510(k) K930357 · Octostop, Inc.
510(k) numberK930357
Submission
- Device name
- Accessory to Universal Octopaque
- Applicant
- Octostop, Inc.
Montreal, Qc., CA - Received
- January 26, 1993
- Decision date
- July 13, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code KXH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122174 | Pediatric Positioner Pad SetKXH · Traditional | Ge Healthcare Coils (Usa Instruments, Inc.) | 11/16/2012SE |
| K953246 | OctorollKXH · Traditional | Octostop, Inc. | 09/29/1995SE |
| K930124 | Variant of Octostop and OctopaqueKXH · Traditional | Octostop, Inc. | 02/09/1994SE |
| K933134 | Spectrum DG-P7000 Pediatric CradleKXH · Traditional | Spectrum X-Ray Corp. | 10/07/1993SE |
| K884292 | Stretcher TableKXH · Traditional | Fischer Imaging Corp. | 03/31/1989SE |
| K863890 | Mamm-AireKXH · Traditional | Ar Custom Medical Products, Ltd. | 10/14/1986SE |
| K840463 | Digital CradleKXH · Traditional | Spectrum X-Ray Corp. | 02/21/1984SE |
| K813561 | Spectrum Pediatric Cardle TableKXH · Traditional | Spectrum X-Ray Corp. | 01/29/1982SE |
More from Spectrum X-Ray Corp.
| 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 |
| K940306 | Octostop Compensating FiltersKPR · Traditional | 09/06/1994SE |
| K935444 | Octostop(R) Chair (New ModelIXR · Traditional | 09/02/1994SE |
| K930124 | Variant of Octostop and OctopaqueKXH · Traditional | 02/09/1994SE |
| K926069 | Wrist TractionKPR · Traditional | 01/21/1993SE |
| K913711 | Gentle SlopeKPR · Traditional | 10/14/1992SE |
Questions and answers
When was Accessory to Universal Octopaque cleared by the FDA?
Accessory to Universal Octopaque (K930357) received a 510(k) decision of Substantially Equivalent on July 13, 1993, 168 days after the submission was received.
What is the product code of K930357?
The FDA product code is KXH – Cradle, Patient, Radiologic, a Class I (low risk) device regulated under 21 CFR 892.1830.