Data / Medical devices / United States / X-Cel X-Ray Corp.
X-Cel X-Ray Corp.: FDA-registered device maker in Crystal Lake, IL, United States, 4 510(k) clearances
X-Cel X-Ray Corp. is registered with the FDA (registration 1418484) in Crystal Lake, IL, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 24, 2017. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1418484
- Address
- 4220 Waller ST --, Crystal Lake, IL, United States, 60012
- Owner or operator
- ARQUILLA, INC DBA X-CEL X-RAY CORP. (1418484)
- Roles
- Manufacturer
- First device listed
- July 20, 1992
- Registered through
- 2026
- Brand names listed
- X-Cel X-Ray Corporation
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assembly, Tube Housing, X-Ray, Diagnostic | ITY | 1 | Manufacturer | accessdata.fda.gov |
| Generator, Dermatological (Grenz Ray), Therapeutic X-Ray | IYH | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 24, 2017 | K160857 | HF 718BD X-Ray System | KPR | Substantially Equivalent | Arquilla, Inc. Dba X-Cel X-Ray Corporation | accessdata.fda.gov |
| August 9, 1993 | K930699 | M6-M | IZL | Substantially Equivalent | X-Cel X-Ray Corp. | accessdata.fda.gov |
| May 14, 1987 | K871116 | X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R | IYH | Substantially Equivalent | X-Cel X-Ray Corp. | accessdata.fda.gov |
| June 23, 1981 | K811230 | X-CELL X-RAY #'S P-75W/P-75M | KPR | Substantially Equivalent | X-Cel X-Ray Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 12, 2002 | 25571 | Not yet classified | Terminated | X-Cel MB-700 A/C Podiatry X-Ray System; X-Cel X-Ray Coporation, 4220 Waller Drive, Crystal Lake, IL 60012 | The X-Ray system contained a defective X-Ray tube shield. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Stationary
- All makers of System, X-Ray, Mobile
- All makers of Assembly, Tube Housing, X-Ray, Diagnostic
Updated February 24, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.