Atlas FDA

PRESTILIX 1690

FDA 510(k) clearance K843926 · decided 1984-12-17

Clearance details

K-number
K843926
Device name
PRESTILIX 1690
Applicant
Cgr Medical Corp.
Decision
Substantially Equivalent
Date received
1984-10-27
Decision date
1984-12-17
Days to decision
51 days
Clearance type
Traditional
Product code
IXR
Device class
2
Regulation number
892.1980
Medical specialty
Radiology
Advisory committee
Radiology
Location
Columbia, MD, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
VISION R/F TILTING TABLE (K000412)Villa Sistemi Medicali S.P.A.2000-04-24
LEGACY/LEGACY-D TABLE (K973039)GE Medical Systems1997-10-16
CAP-35B III/CINE 275 (K971128)Jamieson Film Co.1997-04-28
PHILIPS EASY DIAGNOST (K970640)Philips Medical Systems North America, Inc.1997-03-21
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 (K965105)U.S. Imaging Tables, Inc.1997-01-30
FLUOROVIEW SERIES FLUOROSCOPIC TABLES (K965096)U.S. Imaging Tables, Inc.1997-01-27
TILTING RADIOGRAPHIC TABLE (REMOTE) (K963851)Acoma Medical Imaging, Inc.1997-01-23
TANGENT VI TABLE (K961022)Fischer Imaging Corp.1996-05-03
COMPAX 90/15E (K954356)General Electric Co.1995-10-07
SURGICAL C-ARM TABLE, 9610 (K953557)U.S. Imaging Tables, Inc.1995-09-26
VACS TABLE, 9650 (K953556)U.S. Imaging Tables, Inc.1995-09-26
KOORDINAT M (K951176)Siemens Medical Solutions USA, Inc.1995-04-20

Recalls involving this device

No recalls on record reference this clearance.