Wall Bucky Holders Lt. & Rt. Hand, & Center Mount
FDA 510(k) K925934 · Continental X-Ray Corp.
510(k) numberK925934
Submission
- Device name
- Wall Bucky Holders Lt. & Rt. Hand, & Center Mount
- Applicant
- Continental X-Ray Corp.
Broadview, IL, US - Received
- November 20, 1992
- Decision date
- March 4, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K953402 | Universix 190IXY · Traditional | Philips Medical Systems (Cleveland), Inc. | 08/11/1995SE |
| K953336 | VRS 3 Wall StandIXY · Traditional | Philips Medical Systems (Cleveland), Inc. | 08/11/1995SE |
| K946114 | Sensori-Motor Rating ScaleIXY · Traditional | Cmed | 04/28/1995SE |
| K946260 | NTBS-1417, 1436, TBS-1417IXY · Traditional | Scott Imaging Intl., Inc. | 03/31/1995SE |
| K930249 | Bc/Wt/PfIXY · Traditional | Tingle X-Ray Products, Inc. | 04/27/1993SE |
| K930230 | Radiographic Wall-Mounted Cassette HolderIXY · Traditional | American Medical Sales, Inc. | 04/27/1993SE |
| K924445 | BA-4 Wall Bucky and BA-42 Tilting Wall BuckyIXY · Traditional | Control-X, Inc. | 02/19/1993SE |
| K922443 | Vert-X Universal Vertical Bucky StandIXY · Traditional | Afp Imaging Corp. | 10/26/1992SE |
| K915667 | Model H170 Pediatric Chest X-Ray UnitIXY · Traditional | H.L. Lyons Co. | 01/31/1992SE |
| K895034 | Buckys Models YMB-15A, YMB-15B and YMB-15CIXY · Traditional | Yamato Medical Corp. | 11/15/1989SE |
More from Yamato Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K972442 | Ceiling Mounted Lateral Positioner, Model No. 6896.002JAA · Traditional | 09/11/1997SE |
| K962140 | ICT-2000, Integrated C-Arm/Table Multipurpose Radiographic/Fluoroscopic Positioning…JAA · Traditional | 07/25/1996SE |
| K961690 | Cardioarc Series: Positioner C-Arm Models No. 6896.001 and 6896.105JAA · Traditional | 06/27/1996SE |
| K954581 | Arc SeriesIZI · Traditional | 12/21/1995SE |
| K950571 | Linear FR Tomographic System: 0MT 8000, Model No. 6681.270IZF · Traditional | 03/31/1995SE |
| K942175 | Linear Tomographic System: PMT 6000IZF · Traditional | 08/17/1994SE |
| K942100 | Model TM Ep High Voltage GeneratorIZO · Traditional | 06/07/1994SE |
| K934686 | Molybdenum/Rhodium FiltersIZO · Traditional | 05/26/1994SE |
| K931724 | Electrophysiology (Ep) Table Ep 2000 SeriesKXJ · Traditional | 06/14/1993SE |
| K921986 | Patient Information Manager (Pim)IZH · Traditional | 10/16/1992SE |
Questions and answers
When was Wall Bucky Holders Lt. & Rt. Hand, & Center Mount cleared by the FDA?
Wall Bucky Holders Lt. & Rt. Hand, & Center Mount (K925934) received a 510(k) decision of Substantially Equivalent on March 4, 1993, 104 days after the submission was received.
What is the product code of K925934?
The FDA product code is IXY – Holder, Radiographic Cassette, Wall-Mounted, a Class I (low risk) device regulated under 21 CFR 892.1880.