Krypton Cart
FDA 510(k) K811677 · Medi-Physics Inc. Dba Nycomed Amersham Imaging
510(k) numberK811677
Submission
- Device name
- Krypton Cart
- Applicant
- Medi-Physics Inc. Dba Nycomed Amersham Imaging
Mchenry, IL, US - Received
- June 15, 1981
- Decision date
- July 2, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K110900 | Disposable Thyroid CollarKPY · Traditional | Bloxr Corporation | 06/24/2011SE |
| K962622 | Intra-Oral Thermoplastic ShieldKPY · Traditional | Medtec, Inc. | 10/01/1996SE |
| K954456 | Thermoplastic ShieldKPY · Traditional | Medtec, Inc. | 12/21/1995SE |
| K954146 | Utk-Dte Autilary ShieldKPY · Traditional | Mallinckrodt Medical | 12/06/1995SE |
| K953610 | AukulyteKPY · Traditional | Aukland Medical Plastics, Inc. | 09/26/1995SE |
| K951004 | 2001 Special Procedure Lamp (Low Voltage) (AS Exhibits #2 & 4)KPY · Traditional | Kenex , Ltd. | 04/10/1995SE |
| K951003 | Kenex Radiation Shield (Various Models AS Exhibits #2 & 5)KPY · Traditional | Kenex , Ltd. | 04/03/1995SE |
| K940539 | Stand Imaging Dose Calibrator Shielded Work PlatformKPY · Traditional | Standard Imaging, Inc. | 03/16/1994SE |
| K934206 | Mavig Angio Shield Models 6290 & 6272KPY · Traditional | F. Walter Hanel GmbH | 10/07/1993SE |
| K912378 | Davis Lead Apron/Radiographic Various Cat. NumbersKPY · Traditional | Davis Lead Aprons, Inc. | 03/18/1992SE |
More from Davis Lead Aprons, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K010821 | ECHOSEED/IODINE-125 Seeds, Model 6733KXK · Special | 04/11/2001SE |
| K940632 | I-125 Rapid StrandIWI · Traditional | 09/02/1994SE |
| K921961 | Sdmo Applicator Code: ASN.8236IWJ · Traditional | 07/01/1992SE |
| K915156 | I-125 Seeds Code: 6702KXK · Traditional | 01/06/1992SE |
| K914281 | I-125 Seeds, Code: 6711KXK · Traditional | 11/22/1991SE |
| K914268 | I-125 Seeds in Carrier, Code: 6720KXK · Traditional | 11/22/1991SE |
| K811688 | Tungsten Syringe ShieldIWR · Traditional | 07/02/1981SE |
| K811118 | Krypton Masks & TubingIYT · Traditional | 06/02/1981SE |
Questions and answers
When was Krypton Cart cleared by the FDA?
Krypton Cart (K811677) received a 510(k) decision of Substantially Equivalent on July 2, 1981, 17 days after the submission was received.
What is the product code of K811677?
The FDA product code is KPY – Shield, Protective, Personnel, a Class I (low risk) device regulated under 21 CFR 892.6500.