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510(k) K800998

ATLAS-S X-RAY SYSTEM W/KETROMAT GEN. by General X-Ray, Inc.

K800998 is an FDA 510(k) premarket notification submitted by General X-Ray, Inc. for the device "ATLAS-S X-RAY SYSTEM W/KETROMAT GEN.". The FDA issued a decision of Substantially Equivalent on May 28, 1980. General X-Ray, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1980
Date Received
April 25, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by General X-Ray, Inc.

  • K790451 — X-RAY UNITS, GX-101, UCIS-510 AND GX-111 (March 28, 1979)
  • K790511 — MOBILE X-RAY UNIT (March 26, 1979)
  • K790512 — PORTABLE X-RAY UNIT (March 26, 1979)
  • K790443 — PORTABLE X-RAY UNIT (March 26, 1979)
  • K790392 — 510 CARBINETTE X-RAY UNIT (March 26, 1979)
  • K790393 — PORTABLE X-RAY UNIT, MATRIX S GX-101 (March 26, 1979)
  • K781975 — MOBILE CARRIER (December 4, 1978)
  • K781675 — X-RAY COLLIMATOR (December 4, 1978)
  • K781976 — MOBILE X-RAY UNIT (December 4, 1978)
  • K781676 — X-RAY STAND, PORTABLE (October 17, 1978)

FDA data resources