Medi-Physics Inc. Dba Nycomed Amersham Imaging
United StatesFDA applicant, unverified
- Devices
- 9
What Medi-Physics Inc. Dba Nycomed Amersham Imaging makes
Medi-Physics Inc. manufactures medical devices for radiation therapy and imaging, including sealed radioactive iodine-125 seeds used in brachytherapy, applicators for seed implantation, and specialized shielding for syringes. Their portfolio also covers krypton gas delivery systems, such as masks, tubing, and carts, designed for respiratory applications in medical imaging. These products are intended for precise radiation dosing and patient safety in clinical settings.
The company’s devices are regulated under the FDA’s 510(k) pathway, with products classified as Class I and Class II. Iodine-125 seeds and related applicators fall under Class II due to their higher risk potential, while other items like krypton delivery systems are classified as Class I. These devices are listed in the FDA’s 510(k) clearance registry, reflecting their compliance with U.S. medical device regulations.
Catalogue
Krypton Masks & Tubing Ref K811118
Regimes: 510(k) Registry: 510(k)I-125 Seeds, Code: 6711 Ref K914281
Regimes: 510(k) Registry: 510(k)Sdmo Applicator Code: ASN.8236 Ref K921961
Regimes: 510(k) Registry: 510(k)I-125 Seeds Code: 6702 Ref K915156
Regimes: 510(k) Registry: 510(k)I-125 Rapid Strand Ref K940632
Regimes: 510(k) Registry: 510(k)I-125 Seeds In Carrier, Code: 6720 Ref K914268
Regimes: 510(k) Registry: 510(k)Krypton Cart Ref K811677
Regimes: 510(k) Registry: 510(k)Tungsten Syringe Shield Ref K811688
Regimes: 510(k) Registry: 510(k)Echoseed/Iodine-125 Seeds, Model 6733 Ref K010821
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medi-Physics Inc. Dba Nycomed Amersham Imaging have in the registry?
The registry currently lists 9 devices for Medi-Physics Inc. Dba Nycomed Amersham Imaging. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medi-Physics Inc. Dba Nycomed Amersham Imaging's devices?
Among its 9 most recently registered devices, Medi-Physics Inc. Dba Nycomed Amersham Imaging has devices listed in FDA 510(k) (9 devices).
What risk classes do Medi-Physics Inc. Dba Nycomed Amersham Imaging's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Medi-Physics Inc. Dba Nycomed Amersham Imaging's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medi-Physics Inc. Dba Nycomed Amersham Imaging in the registry?
The most recently registered devices listed for Medi-Physics Inc. Dba Nycomed Amersham Imaging include KRYPTON MASKS & TUBING, I-125 SEEDS, CODE: 6711, SDMO APPLICATOR CODE: ASN.8236 and I-125 SEEDS CODE: 6702.