Spectrum Automatic Chest Unit Model C
FDA 510(k) K791811 · Spectrum X-Ray Corp.
510(k) numberK791811
Submission
- Device name
- Spectrum Automatic Chest Unit Model C
- Applicant
- Spectrum X-Ray Corp.
Mchenry, IL, US - Received
- September 18, 1979
- Decision date
- October 26, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K945635 | Trans X-1000KPX · Traditional | Canon USA, Inc. | 02/01/1995SE |
| K935157 | Articulated, Laparoscopic, and Side-Viewing T-ProbesKPX · Traditional | Regulatory Consultants TO the Medical Device Indus | 08/09/1994SE |
| K934850 | Nuclear Associates Personnel Protective ShieldsKPX · Traditional | Victoreen, Inc. | 11/22/1993SE |
| K933035 | BCM-600TXKPX · Traditional | B C Medical , Ltd. | 10/08/1993SE |
| K925598 | Buckymatic Automatic Chest Film ChangerKPX · Traditional | Acoma Medical Imaging, Inc. | 02/01/1993SE |
| K924423 | MWX-7440 High Speed BuckyKPX · Traditional | Midwest X-Ray Equipment Co. | 01/15/1993SE |
| K925169 | Shimadzu Radiograpjhic Stand BR-100KPX · Traditional | Shimadzu Medical Systems | 12/03/1992SE |
| K920196 | OX-600KPX · Traditional | Stardard X-Ray Sales Co. | 10/14/1992SE |
| K922483 | Du Pont Compact Daylight System 2000KPX · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/11/1992SE |
| K905789 | Franklin 9000 Wall StandKPX · Traditional | Mallinckrodt Group, Inc. | 05/20/1991SE |
More from Mallinckrodt Group, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K933134 | Spectrum DG-P7000 Pediatric CradleKXH · Traditional | 10/07/1993SE |
| K931563 | Spectrum Mark I Special Procedures TableIXR · Traditional | 08/23/1993SE |
| K870707 | Pentamax 1 Model B Table SystemIXR · Traditional | 05/14/1987SE |
| K840463 | Digital CradleKXH · Traditional | 02/21/1984SE |
| K834494 | Spectrum X-Ray CorpIZZ · Traditional | 02/21/1984SE |
| K827450 | Simplamatic III · Traditional | 05/19/1982SE |
| K813561 | Spectrum Pediatric Cardle TableKXH · Traditional | 01/29/1982SE |
| K791812 | Spectrum Emergency & Trauma Table SystemIXR · Traditional | 11/05/1979SE |
Questions and answers
When was Spectrum Automatic Chest Unit Model C cleared by the FDA?
Spectrum Automatic Chest Unit Model C (K791811) received a 510(k) decision of Substantially Equivalent on October 26, 1979, 38 days after the submission was received.
What is the product code of K791811?
The FDA product code is KPX – Changer, Radiographic Film/Cassette, a Class II (moderate risk) device regulated under 21 CFR 892.1860.