Chicago X-Ray Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Rotograph Plus Ref K972968
Regimes: 510(k) Registry: 510(k)Flash Dent Ref K931300
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Explor-X (Azteh) Hf Ref K954565
Regimes: 510(k) Registry: 510(k)
FDA recalls
2012
- 3 Jul 2012 Z-1179-2013 Class II Terminated The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 1010.3. Also, the user's manual was found to have missing or improperly labeled information as required by 21 CFR 1020.30(h).
Frequently asked questions
How many devices does Chicago X-Ray Systems, Inc. have in the registry?
The registry currently lists 4 devices for Chicago X-Ray Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Chicago X-Ray Systems, Inc.'s devices?
Among its 4 most recently registered devices, Chicago X-Ray Systems, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Chicago X-Ray Systems, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Chicago X-Ray Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Chicago X-Ray Systems, Inc.?
FDA recall records list 1 recall initiated by Chicago X-Ray Systems, Inc., the most recent initiated on 3 Jul 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Chicago X-Ray Systems, Inc. in the registry?
The most recently registered devices listed for Chicago X-Ray Systems, Inc. include ROTOGRAPH PLUS, FLASH DENT, AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER and EXPLOR-X (AZTEH) HF.