American Science & Engineering, Inc.

FDA Regulatory Profile

American Science & Engineering, Inc. appears in FDA public data with 1 recall, 3 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2206-2015, Class II) was initiated on May 22, 2015. Its most recent 510(k) clearance was granted on December 8, 1983.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2206-2015Class IIAmerican Science & Engineering Inc,Gemini Cabinet X-ray system.May 22, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K833237DIGITAL RADIOGRAPHY SYS DUAL GANTRIESDecember 8, 1983
K761004X-RAY SCANNER, WHOLE BODY, AS&EDecember 16, 1976
K760201X-RAY SCANNER, COMPUTERIZED TOMOGRAPHICOctober 5, 1976