Fischer Imaging Corp.
Denver, CO, US
Fischer Imaging Corp. appears in FDA device records in Denver, CO. FDA records list 69 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 11 recalls for this company.
FDA records held for this company
510(k) clearance history
Showing 50 of 69FDA records hold 69 510(k) clearances for Fischer Imaging Corp. between 1981 and 2004. The busiest year on record is 1988, with 21. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1986 | 2 |
| 1988 | 21 |
| 1989 | 7 |
| 1990 | 2 |
| 1991 | 10 |
| 1992 | 8 |
| 1993 | 3 |
| 1994 | 6 |
| 1995 | 2 |
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K042095 | MAMMOTEST | IZH | Substantially Equivalent | |
| K021113 | MAMMOPATH | MWP | Substantially Equivalent | |
| K981414 | LC POSITIONER | JAA | Substantially Equivalent | |
| K973400 | MAMMOTEST ADAPTER DRIVER | IZH | Substantially Equivalent | |
| K964806 | MD-1835 | IXL | Substantially Equivalent | |
| K961207 | EP-X BIPLANE | JAA | Substantially Equivalent | |
| K961022 | TANGENT VI TABLE | IXR | Substantially Equivalent | |
| K950291 | DIGITAL 625HF | IZO | Substantially Equivalent | |
| K945619 | ATHENA HFX | IZH | Substantially Equivalent | |
| K944150 | MICRO X-65 HF | IZO | Substantially Equivalent | |
| K944149 | MICRO X-80 HF | IZO | Substantially Equivalent | |
| K944148 | MICRO X-30HF | IZO | Substantially Equivalent | |
| K944147 | MICRO X-50 HF | IZO | Substantially Equivalent | |
| K943504 | RSX-525HF | IZO | Substantially Equivalent | |
| K926560 | EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER | JAA | Substantially Equivalent | |
| K934481 | EP-X | JAA | Substantially Equivalent | |
| K930792 | RSX 30HF | IZO | Substantially Equivalent | |
| K926575 | MAMMOTEST PRODUCT, MODIFICATION | EHD | Substantially Equivalent | |
| K924137 | CSP-A (CEILING SUSPENDED POSITIONER-ANGIO) | IZI | Substantially Equivalent | |
| K924345 | RADIOGRAPHIC FILM MARKETING SYSTEM | JAC | Substantially Equivalent | |
| K914748 | COMET C-125 | OXO | Substantially Equivalent | |
| K922454 | MOBILE ATHENA HF | IZH | Substantially Equivalent | |
| K923061 | MAMMOSCAN | IZH | Substantially Equivalent | |
| K915853 | TANGENT V | IXR | Substantially Equivalent | |
| K915199 | STORZ IMAGING SYSTEM | IZI | Substantially Equivalent | |
| K915592 | PEGASUS LATERAL CARDIAC POSITIONER | JAA | Substantially Equivalent | |
| K914266 | MICRO-X 30 HF | IZO | Substantially Equivalent | |
| K914236 | MICRO-X 50 HF | IZO | Substantially Equivalent | |
| K905694 | FVP-1000 FAMILY AND FVP-1000D FAMILY | JAA | Substantially Equivalent | |
| K912741 | ELITE R 90/15 | IXR | Substantially Equivalent | |
| K910647 | XIMATRON/CT OPTION | KPQ | Substantially Equivalent | |
| K912449 | MICRO-X 15 HF | IZO | Substantially Equivalent | |
| K912448 | CSP | OWB | Substantially Equivalent | |
| K912586 | TANGENT IV | IXR | Substantially Equivalent | |
| K905695 | MICRO-X 80HF | IZO | Substantially Equivalent | |
| K905501 | ELITE 5000 | IXR | Substantially Equivalent | |
| K900989 | ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM | IZH | Substantially Equivalent | |
| K900234 | PFM-90 CEILING TUBE SUPPORT | IYB | Substantially Equivalent | |
| K894913 | DA-100HS | JAA | Substantially Equivalent | |
| K893674 | RME 325R | IZO | Substantially Equivalent | |
| K893673 | RMS 180 | IXR | Substantially Equivalent | |
| K893653 | RADIOGRAPHIC CEILING TUBE SUPPORT CTS15 | IYB | Substantially Equivalent | |
| K893652 | RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60 | IYB | Substantially Equivalent | |
| K884292 | STRETCHER TABLE | KXH | Substantially Equivalent | |
| K885127 | SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM | LMC | Substantially Equivalent | |
| K883976 | CFX 625 | IZO | Substantially Equivalent | |
| K883985 | CARDIAC CX | JAA | Substantially Equivalent | |
| K883860 | ADVANTAGE | IZI | Substantially Equivalent | |
| K883831 | IMAGER | IZI | Substantially Equivalent | |
| K884134 | MICRO-X 100CP | IZO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MWPCabinet, X-Ray System
- LMCCamera, Multi Format, Radiological
- KXHCradle, Patient, Radiologic
- IXLDevice, Spot-Film
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile
- OWBInterventional Fluoroscopic X-Ray System
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- KPQSystem, Simulation, Radiation Therapy
- IZISystem, X-Ray, Angiographic
- JACSystem, X-Ray, Film Marking, Radiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZHSystem, X-Ray, Mammographic
- IZZTable, Radiographic, Non-Tilting, Powered
- IXRTable, Radiographic, Tilting
- IYBTube Mount, X-Ray, Diagnostic
- EHDUnit, X-Ray, Extraoral With Timer
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0757-06 | SenoScan Full Field Digital Mammography System--Product Number 94001G-3, 105200G | Software upgrade to preclude lost images during mammography procedure. | Terminated | ||
| Z-1527-05 | Electrophysiology Imaging System | Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient. | Terminated | ||
| Z-1526-05 | Electrophysiology Imaging System | Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient. | Terminated | ||
| Z-1525-05 | Electrophysiology Imaging System | Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient. | Terminated | ||
| Z-1524-05 | Electrophysiology Imaging System | Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient. | Terminated | ||
| Z-0713-05 | Bloom DTU-215-B Programmable Stimulator | Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients. | Terminated | ||
| Z-0787-05 | VersaRad Generator | Some VersaRad Systems have a faulty weld that may result in oil leakage. | Terminated | ||
| Z-0379-05 | MammoTest Breast Biopsy System. | X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning. | Terminated | ||
| Z-1094-04 | Fischer SenoScan True View Digital Mammography System. | Existing software may allow Image data to be truncated in the margin of the breast on processed patient images. | Terminated | ||
| Z-0974-04 | VersaRad/Traumex General Radiographic System. | If two of the four T-nuts that connect the transverse rail to the ceiling rail fail, the 'U' arm and transverse rails could fall and cause serious injury. | Terminated | ||
| Z-0939-04 | SenoScan True View Digital Mammography System | X-ray tube may overheat after high usage because of mis-wired thermal switch circuit. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain