Computerized Imaging Reference Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Computerized Imaging Reference Systems, Inc. makes
Computerized Imaging Reference Systems, Inc. manufactures tissue-equivalent breast simulators and bone density CT phantoms, which are used for calibration, quality assurance, and testing in medical imaging systems. These devices replicate anatomical structures to help ensure accurate imaging diagnostics and equipment performance.
The company’s products are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for use in the United States, where they are subject to compliance with FDA standards for medical imaging phantoms and simulators.
Catalogue
- Registry: GUDID
- Registry: GUDID
Tissue-Equivalent Breast Simulator Ref K865100
Regimes: 510(k) Registry: 510(k)Bone Density Ct Phantom Ref K852528
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 108245655
- [email protected]
- Phone
- (321) 259-6862
Frequently asked questions
How many devices does Computerized Imaging Reference Systems, Inc. have in the registry?
The registry currently lists 4 devices for Computerized Imaging Reference Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Computerized Imaging Reference Systems, Inc.'s devices?
Among its 4 most recently registered devices, Computerized Imaging Reference Systems, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Computerized Imaging Reference Systems, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Computerized Imaging Reference Systems, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Computerized Imaging Reference Systems, Inc. in the registry?
The most recently registered devices listed for Computerized Imaging Reference Systems, Inc. include Precision Cut EBT3 GafChromic(TM) Film 158200, TISSUE-EQUIVALENT BREAST SIMULATOR and BONE DENSITY CT PHANTOM.