510(k) K791811

SPECTRUM AUTOMATIC CHEST UNIT MODEL C by Spectrum X-Ray Corp. — Product Code KPX

K791811 is an FDA 510(k) premarket notification submitted by Spectrum X-Ray Corp. for the device "SPECTRUM AUTOMATIC CHEST UNIT MODEL C". The FDA issued a decision of Substantially Equivalent on October 26, 1979. The device falls under product code KPX (Changer, Radiographic Film/Cassette), a Class II device regulated under 21 CFR 892.1860. Spectrum X-Ray Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1979
Date Received
September 18, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Changer, Radiographic Film/Cassette
Device Class
Class II
Regulation Number
892.1860
Review Panel
RA
Submission Type