Atlas FDA

RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.

FDA 510(k) clearance K871555 · decided 1988-03-02

Clearance details

K-number
K871555
Device name
RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.
Applicant
General Electric Co.
Decision
Substantially Equivalent
Date received
1987-04-22
Decision date
1988-03-02
Days to decision
315 days
Clearance type
Traditional
Product code
DXK
Device class
2
Regulation number
870.2330
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Milwaukee, WI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S017)General Electric Co.1988-07-29
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S013)General Electric Co.1988-07-15
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S016)General Electric Co.1988-06-30
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S014)General Electric Co.1988-05-05
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S015)General Electric Co.1988-05-02
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S012)General Electric Co.1987-11-25
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S011)General Electric Co.1987-06-18
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S010)General Electric Co.1987-03-30