GE Healthcare Coils
Aurora, OH, US
GE Healthcare Coils appears in FDA device records in Aurora, OH. FDA records list 64 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to GE Healthcare Coils carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- USA Instruments Incorporatedrecall
- Usa Instruments, Inc.510(k), recall
510(k) clearance history
Showing 50 of 64FDA records hold 64 510(k) clearances for GE Healthcare Coils between 1997 and 2005. The busiest year on record is 2003, with 18. The most recent is 2005, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 3 |
| 1998 | 3 |
| 2000 | 12 |
| 2001 | 5 |
| 2002 | 11 |
| 2003 | 18 |
| 2004 | 7 |
| 2005 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K052916 | USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY | MOS | Substantially Equivalent | |
| K052621 | 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL | MOS | Substantially Equivalent | |
| K052584 | 1.5T 12 CHANNEL BODY ARRAY | MOS | Substantially Equivalent | |
| K052585 | 3T HD BREAST ARRAY | MOS | Substantially Equivalent | |
| K050728 | OPEN BREAST COIL (OBC) WITH BIOPSY PLATES | MOS | Substantially Equivalent | |
| K042342 | MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL | MOS | Substantially Equivalent | |
| K042207 | 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL | MOS | Substantially Equivalent | |
| K042186 | 3.0T 8-CHANNEL CTL SPINE ARRAY | MOS | Substantially Equivalent | |
| K042009 | MARK III PHASED ARRAY SHOULDER COIL | MOS | Substantially Equivalent | |
| K041695 | LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE | LNH | Substantially Equivalent | |
| K041487 | QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT | MOS | Substantially Equivalent | |
| K033490 | SPIRIT 5000 CARDIAC COIL | MOS | Substantially Equivalent | |
| K033753 | PELVIC ARRAY COIL | MOS | Substantially Equivalent | |
| K033235 | GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL | MOS | Substantially Equivalent | |
| K033353 | MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES | MOS | Substantially Equivalent | |
| K032618 | 3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL | MOS | Substantially Equivalent | |
| K032538 | 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL | MOS | Substantially Equivalent | |
| K032474 | 3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL | MOS | Substantially Equivalent | |
| K032415 | MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL | MOS | Substantially Equivalent | |
| K031365 | PRIMA III TOTALSENSE TORSO COIL | MOS | Substantially Equivalent | |
| K031366 | PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL | MOS | Substantially Equivalent | |
| K031172 | SPIRIT III TOTALSENSE CARDIAC COIL | MOS | Substantially Equivalent | |
| K031143 | ALPHA 5000 WRIST COIL | MOS | Substantially Equivalent | |
| K031139 | PREMIER III PHASED ARRAY CTL SPINE COIL | MOS | Substantially Equivalent | |
| K031056 | MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL | MOS | Substantially Equivalent | |
| K030371 | PRIMA III TOTALSENSE TORSO COIL | MOS | Substantially Equivalent | |
| K030042 | PREMIER III PHASED ARRAY CTL SPINE COIL | MOS | Substantially Equivalent | |
| K023982 | LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST COIL | MOS | Substantially Equivalent | |
| K024187 | SPIRIT III TOTALSENSE CARDIAC COIL | MOS | Substantially Equivalent | |
| K023650 | INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL | MOS | Substantially Equivalent | |
| K023247 | CHAMPION 5000 PERIPHERAL VASCULAR COIL | MOS | Substantially Equivalent | |
| K022007 | LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES | MOS | Substantially Equivalent | |
| K022582 | EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL | MOS | Substantially Equivalent | |
| K021330 | MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL | MOS | Substantially Equivalent | |
| K021141 | MILLENNIUM 5000 MEUROVASCULAR COIL | MOS | Substantially Equivalent | |
| K021262 | MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL | MOS | Substantially Equivalent | |
| K013854 | MARK 5000 QUADRATURE SHOULDER COIL | MOS | Substantially Equivalent | |
| K014086 | CTL BODY / SPINE ARRAY COIL | MOS | Substantially Equivalent | |
| K013595 | PREMIER III PHASED ARRAY CTL SPINE COIL | MOS | Substantially Equivalent | |
| K013594 | BODY ARRAY COIL | MOS | Substantially Equivalent | |
| K013592 | EXTREMITY COIL | MOS | Substantially Equivalent | |
| K013541 | SHOULDER COIL | MOS | Substantially Equivalent | |
| K013528 | CRYSTAL 5000 PHASES ARRAY TMJ COIL | MOS | Substantially Equivalent | |
| K011683 | NURVO 9000 ENDOCAVITARY COILS | MOS | Substantially Equivalent | |
| K010946 | MARK 9000 PHASED ARRAY SHOULDER COIL | MOS | Substantially Equivalent | |
| K010730 | MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL | MOS | Substantially Equivalent | |
| K002483 | POWER 5000 GENERAL PURPOSE COIL | MOS | Substantially Equivalent | |
| K002482 | VISION 9000 PHASED ARRAY TORSO COIL | MOS | Substantially Equivalent | |
| K001870 | MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL | MOS | Substantially Equivalent | |
| K001582 | LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE | MOS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1529041 | 3005214683 | GE Healthcare Coils | 1515 DANNER DR, AURORA, OH 44202 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0519-2007 | The recalled product is the Large grid biopsy plate, part #2414797. The biopsy plate is labeled in part: Large Grid Biopsy Plate, part 2414797, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The large grid biopsy plate is packaged and sold as a part of catalogue 2414798 and 2415277. | The packaging used for the Breast Biopsy plate may exhibit small holes or tears. | Terminated | ||
| Z-0518-2007 | The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is labeled in part: Disposable Biopsy Plate, part U1-150131, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with GE coils and with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The disposable biopsy plate for use with GE coils is packaged and sold as a part of catalogue U1-160051, U1-150190, U1-150131. The disposable biopsy plate for use with OEM coils is packaged and sold as part of catalogue U1-150226, U1-150190, U1-155068, U1-160016, U1-160052, U1-160085, U1-160166, U1-160175, 2412158, 2416938, 2417842, and U1-150131. | The packaging used for the Breast Biopsy plate may exhibit small holes or tears | Terminated | ||
| Z-0517-2007 | The recalled product is the Lateral biopsy plate, part #2414346. The biopsy plate is labeled in part: Lateral Biopsy Plate, part 2414346, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with GE coils during Magnetic Resonance breast biopsy procedures. The lateral biopsy plate is packaged and sold as a part of catalogue E8800BG, M3087JG, G3087JH, M3335LA. | The packaging used for the Breast Biopsy plate may exhibit small holes or tears | Terminated | ||
| Z-0516-2007 | The recalled product is the medial biopsy plate, part #2414342. The biopsy plate is labeled in part: Medial Biopsy Plate, part 2414342, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with GE coils during Magnetic Resonance breast biopsy procedures. The medial biopsy plate, part #2414342 is packaged and sold as a part of catalogue numbers E8800BF, M3087JG, G3087JH, and M3335LA. | The packaging used for the Breast Biopsy plate may exhibit small holes or tears | Terminated | ||
| Z-0505-2007 | LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral Biopsy plate is sent to customers in the following configurations: 1) The plate is purchased in sets of 5 as part number E8800BG 8 Channel Breast Biopsy Lateral Grids (pack of 5 grids) or 2) the plate is purchased in pairs with the following part numbers: M3087JG, which contains Liberty 9000 8-Channel Breast Coil, 2 plates and a manual; G3087JH, which contains 2 plates and a manual; M3335LA, which contains a 3T HD 8 channel Vibrant Breast Array, 2 plates and a manual. | The packaging used for the Breast Biopsy Plate may exhibit small holes or tears. | Terminated | ||
| Z-0164-2007 | 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System. | The firm determined that certain potential conditions for use of their medical device, outside of recommended practices, or operating manual descriptions, could result in a localized RF burn and/or electrical shock to a patient on which the device is being used. | Terminated | ||
| Z-0163-2007 | 1.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System. | The firm determined that certain potential conditions for use of their medical device, outside of recommended practices, or operating manual descriptions, could result in a localized RF burn and/or electrical shock to a patient on which the device is being used. | Terminated | ||
| Z-0849-04 | Prima III TotalSENSE Torso Coil (Body Array Coil), labeled as Manufactured by: USA Instruments, Inc. This device is a component of the Magnetom TRIO 3.0T MRI Systems, manufactured by Siemens AG Medical Solutions. | A defective capacitor in the Body Array Coil may result in unstable, unreliable performance, with excessive heating of patient's body. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain