X-Cel X-Ray Corp.
Country not established FDA establishment FEI 1418484
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 1
What X-Cel X-Ray Corp. makes
X-CEL X-Ray Corp. manufactures intraoral and panoramic dental X-ray systems, including the IDX-60 intraoral X-ray unit and the ORT90 series (ORT90W, ORT90M, ORT90R) for panoramic imaging. Their portfolio also includes the P-75W/P-75M X-ray units and the M6-M model, designed for dental radiography applications.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company’s products are intended for use in the United States, where they are subject to compliance with U.S. medical device regulations.
Catalogue
Idx-60 Intraoral X-Ray Ref K993958
510(k) 510(k)X-Cel X-Ray Models ORT90W, ORT90M And ORT90R Ref K871116
510(k) 510(k)X-Cell X-Ray #'s P-75W/P-75M Ref K811230
510(k) 510(k)M6-M Ref K930699
510(k) 510(k)
Company details
- FDA FEI number
- 1418484
- Address
- 4220 WALLER ST, Crystal Lake, IL, 60012
FDA recalls
FDA recall records list 1 recall initiated by X-CEL X-RAY CORP., initiated on 2002-11-12. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2002
- 12 Nov 2002 Z-0424-03 Unclassified (pre-2012) Terminated The X-Ray system contained a defective X-Ray tube shield.
Frequently asked questions
How many devices does X-CEL X-RAY CORP. have in the registry?
The registry currently lists 4 devices for X-CEL X-RAY CORP.. Devices recorded under merged duplicate company entries are counted once.
Which registries list X-CEL X-RAY CORP.'s devices?
Among its 4 most recently registered devices, X-CEL X-RAY CORP. has devices listed in FDA 510(k) (4 devices).
What risk classes do X-CEL X-RAY CORP.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for X-CEL X-RAY CORP.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for X-CEL X-RAY CORP.?
FDA recall records list 1 recall initiated by X-CEL X-RAY CORP., the most recent initiated on 2002-11-12. 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 X-CEL X-RAY CORP. in the registry?
The most recently registered devices listed for X-CEL X-RAY CORP. include IDX-60 INTRAORAL X-RAY, X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R, X-CELL X-RAY #'S P-75W/P-75M and M6-M.