Table, Radiographic, Stationary Top
Regulation 892.1980
0510(k)s in 12 months (27 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in IXQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Med Tec Inc | 0 | 4 |
| Civco Medical Instruments Inc | 0 | 3 |
| Atomic Products Corp. | 2 | 0 |
| Continental X-Ray Corp. | 2 | 0 |
| Garrels X-Ray Products, Inc. | 2 | 0 |
| Medtec, Inc. | 2 | 0 |
| Tecnomed, Inc. | 2 | 0 |
| Altairex Manufacturing, Inc. | 1 | 0 |
| Brattle Instrument Corp. | 1 | 0 |
| Carolina X-Ray Co., Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2011 | Civco Medical Instruments Inc CIVCO SBRT System, REF MTSBRT001L, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa
Product Usage: The recalled product is intended to support and a Terminated |
IXQ | K973842 |
| Aug 15, 2011 | Civco Medical Instruments Inc CIVCO SBRT System, REF MTSBRT001, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa
Product Usage: The recalled product is intended to support and ai Terminated |
IXQ | K973842 |
| Aug 15, 2011 | Civco Medical Instruments Inc CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa
Product Usage: The recalled product is intended to support and aid in positioning a patient during radiologic Terminated |
IXQ | K973842 |
| Nov 16, 2010 | Med Tec Inc CIVCO Posifix Extension, REF MTIL6606, Reusable non-sterile extension for use with the Universal Couchtop. The firm name on the label is CIVCO, Orange City, IA.
For use to support and aid in positi Terminated |
IXQ | K973842 |
| Nov 16, 2010 | Med Tec Inc CIVCO Type-S Extension, REF MTIL6605, Reusable non-sterile extension for use with Universal Couchtop. The firm name on the label is CIVCO, Orange City, IA.
For use to support and aid in positioning Terminated |
IXQ | K973842 |
| Nov 16, 2010 | Med Tec Inc CIVCO Rectangular Extension, REF MTIL6600, Reusable non-sterile extension for use with Universal Couchtop. The firm name on the label is CIVCO, Orange City, IA.
For use to support and aid in positio Terminated |
IXQ | K973842 |
| Aug 20, 2009 | Med Tec Inc Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion. Terminated |
IXQ | K973842 |
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