Atlas FDA

GE QUASAR NUCLEAR MEDICINE SYSTEM

FDA 510(k) clearance K022960 · decided 2002-09-19

Clearance details

K-number
K022960
Device name
GE QUASAR NUCLEAR MEDICINE SYSTEM
Applicant
Ge Medical Systems F.I. Haifa
Decision
Substantially Equivalent
Date received
2002-09-06
Decision date
2002-09-19
Days to decision
13 days
Clearance type
Traditional
Product code
KPS
Device class
2
Regulation number
892.1200
Medical specialty
Radiology
Advisory committee
Radiology
Location
Tirat Hacarmel, IL
Third-party review
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system recall (Z-2097-2025)GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING2025-07-08
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H30 recall (Z-0888-2025)GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING2025-01-10
GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomograph recall (Z-0897-2025)GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING2025-01-10
GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000 recall (Z-0898-2025)GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING2025-01-10
GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H279 recall (Z-0899-2025)GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING2025-01-10
GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, recall (Z-0184-2015)GE Healthcare, LLC2014-12-16
GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD recall (Z-0185-2015)GE Healthcare, LLC2014-12-16
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models recall (Z-0186-2015)GE Healthcare, LLC2014-12-16
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3 recall (Z-0187-2015)GE Healthcare, LLC2014-12-16
Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system i recall (Z-0188-2015)GE Healthcare, LLC2014-12-16
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models recall (Z-0189-2015)GE Healthcare, LLC2014-12-16
GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable recall (Z-1198-2014)GE Healthcare, LLC2014-03-13
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Qua recall (Z-1199-2014)GE Healthcare, LLC2014-03-13
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usag recall (Z-1200-2014)GE Healthcare, LLC2014-03-13
GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye recall (Z-1787-2013)GE Healthcare, LLC2013-07-24
GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual recall (Z-1078-2013)GE Healthcare, LLC2013-04-10
GE Healthcare Infinia, Model Numbers: ASM000886, ASM001391, ASM001333, ASM001465, ASM00147 recall (Z-1001-2009)GE Medical Systems, LLC2009-04-21
GE Healthcare Infinia Hawkeye, Model Numbers: H3000WR, H3000WW, H3000WZ, H3000YM and H3000 recall (Z-1002-2009)GE Medical Systems, LLC2009-04-21
GE Healthcare Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD. P recall (Z-1003-2009)GE Medical Systems, LLC2009-04-21
GE Healthcare Infinia Hawkeye(R), Model numbers: H2508PY H3000WN H3000WR H3000WW H3000WY H recall (Z-1094-2009)GE Medical Systems, LLC2009-04-10
GE Healthcare Infinia Hawkeye(R) 4, Model numbers: H3000WC H3000WD Intended use: To perfor recall (Z-1095-2009)GE Medical Systems, LLC2009-04-10
GE Healthcare, Infinia, Model Numbers: ASM000886 ASM001391 ASM001333 ASM001465 ASM001473 A recall (Z-1119-2009)GE Medical Systems, LLC2009-04-10
GE Healthcare, Hawkeye for Infinia, Model Numbers: H3000WR , H3000WW, H3000WZ , H3000YM an recall (Z-1120-2009)GE Medical Systems, LLC2009-04-10
GE Healthcare, Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD. recall (Z-1121-2009)GE Medical Systems, LLC2009-04-10