American Science and Engineering, Inc.
Mchenry, IL, US
American Science and Engineering, Inc. appears in FDA device records in Mchenry, IL. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for American Science and Engineering, Inc. between 1976 and 1983. The busiest year on record is 1976, with 2. The most recent is 1983, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1983 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K833237 | DIGITAL RADIOGRAPHY SYS DUAL GANTRIES | JAA | Substantially Equivalent | |
| K761004 | X-RAY SCANNER, WHOLE BODY, AS&E | IZF | Substantially Equivalent | |
| K760201 | X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC | JAK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2206-2015 | American Science & Engineering Inc,Gemini Cabinet X-ray system. | During factory testing, we discovered that Gemini systems could, in rare circumstances, experience a fault that leads to a state in which X-rays are being produced but the X-ray indicator lights (located on the operator's console and on both ends of the tunnel) are not illuminated. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain