Machlett Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Machlett Laboratories, Inc. makes
Machlett Laboratories, Inc. manufactures calibration tools and imaging components for medical diagnostics, including a 1.5-inch focal spot resolution pattern for X-ray equipment and gamma cameras used in nuclear medicine imaging. Their portfolio also includes the RDP-2000, a device related to radiation dose measurement and quality assurance in medical imaging systems.
The company’s products are regulated under FDA Class I and Class II categories, with some devices authorised via the 510(k) pathway. Their devices are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
1.5` Focal Spot Resolution Pattern Ref K810254
Regimes: 510(k) Registry: 510(k)Rdp-2000 Ref K813158
Regimes: 510(k) Registry: 510(k)Raytheon Medical Imaging Ref K802888
Regimes: 510(k) Registry: 510(k)Gamma Camera Ref K780969
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Machlett Laboratories, Inc. have in the registry?
The registry currently lists 4 devices for Machlett Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Machlett Laboratories, Inc.'s devices?
Among its 4 most recently registered devices, Machlett Laboratories, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Machlett Laboratories, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Machlett Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Machlett Laboratories, Inc. in the registry?
The most recently registered devices listed for Machlett Laboratories, Inc. include 1.5` FOCAL SPOT RESOLUTION PATTERN, RDP-2000, RAYTHEON MEDICAL IMAGING and GAMMA CAMERA.