Virtual Imaging, Inc.
Deer Field, IL, US
Virtual Imaging, Inc. appears in FDA device records in Deer Field, IL. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Virtual Imaging, Inc. between 1987 and 2010. The busiest year on record is 2009, with 3. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1989 | 1 |
| 1992 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 3 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K093688 | CANON, MODEL URS-50RF | OWB | Substantially Equivalent | |
| K092439 | CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF | OWB | Substantially Equivalent | |
| K092280 | CYPHER DICOM PRINT SOLUTION | LMC | Substantially Equivalent | |
| K083725 | RADPRO ION | OWB | Substantially Equivalent | |
| K070390 | FLUOROPRO RF DIGITAL IMAGING SYSTEM | JAA | Substantially Equivalent | |
| K063262 | AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS | IZL | Substantially Equivalent | |
| K922313 | P-LINK | KPS | Substantially Equivalent | |
| K891695 | VIEW 1000 | LLZ | Substantially Equivalent | |
| K864854 | VIEW(TM) IMAGE PROCESSING AND VIEWING STATION | LLZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0460-2019 | RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography | There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separate from the Tube Head Mount and potentially fall off the system. | Class II | Terminated | |
| Z-1064-2015 | Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients. | There is a potential for unintended and erratic motion. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain