Automatic Cassette Loader
FDA 510(k) K902761 · Mallinckrodt Group, Inc.
510(k) numberK902761
Submission
- Device name
- Automatic Cassette Loader
- Applicant
- Mallinckrodt Group, Inc.
Cincinnati, OH, US - Received
- June 25, 1990
- Decision date
- October 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 |
|---|---|---|
| K945053 | LF CT Hig Pressure CathetersFOZ · Traditional | 05/19/1995SE |
| K945140 | Uro-FloLJH · Traditional | 03/08/1995SE |
| K943581 | Hydradjust IV Urological TableIXR · Traditional | 01/04/1995SE |
| K943122 | Surgical DrapesKKX · Traditional | 09/07/1994SE |
| K934664 | HydragownFYA · Traditional | 05/24/1994SE |
| K920742 | Hydrajust IV Urological TableIXR · Traditional | 04/27/1992SE |
| K912944 | CT 8000 Digital Injection SystemDXT · Traditional | 02/04/1992SE |
| K913264 | Hydraview 1000 Digital Image Process/Stor DeviceLLZ · Traditional | 11/01/1991SE |
| K905789 | Franklin 9000 Wall StandKPX · Traditional | 05/20/1991SE |
| K904147 | Hugh Young II Urological X-Ray SystemKPR · Traditional | 12/13/1990SE |
Questions and answers
When was Automatic Cassette Loader cleared by the FDA?
Automatic Cassette Loader (K902761) received a 510(k) decision of Substantially Equivalent on October 9, 1990, 106 days after the submission was received.
What is the product code of K902761?
The FDA product code is KPX – Changer, Radiographic Film/Cassette, a Class II (moderate risk) device regulated under 21 CFR 892.1860.