Gastroenterology/Urology Diagnostic Ultrasound Devices
Definition: To Provide Ultrasonic Visualization Of Body Cavities That Can Be Accessed By Endoscope. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www. Gpo. Gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007. Pdf).
Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]
| Radiation Type | Acoustic |
| Radition Safety | Abbreviated |
| Annual Reports | No |
| 2074 | Endoscopic Ultrasound System, Gastroenterology-urology | Endoscope And Accessories. |
| 2074 | Endoscopic Ultrasound System, Gastroenterology-urology | Endoscope And Accessories. |
| K221952 | Endoscope Model EG-580UT And Endoscope Model EG-580UR | FUJIFILM Corporation |
| K221238 | FUJIFILM Ultrasonic Endoscope EG-740UT | FUJIFILM Corporation |
| K214089 | FUJIFILM Ultrasonic Processor SP-900 And FUJIFILM Ultrasonic Probe PB2020-M2 | Fujifilm Corporation |
| K203166 | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | PENTAX Of America, Inc. |
| K200090 | PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) | PENTAX Of America, Inc. |
| K183433 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation |
| K182004 | PENTAX Medical Endoscopic Ultrasound System | PENTAX Of America, Inc. |
| K180731 | Ultramatrix EUS Balloon | United States Endoscopy Group, Inc. (US Endoscopy) |
| K173184 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific |
| K172309 | Endoscopic Ultrasound Aspiration Needle | Micro-Tech (Nanjing) CO.,Ltd. |
| K171207 | FUJIFILM Ultrasonic Processor SP-900 And FUJIFILM Ultrasonic Probe PB2020-M | FUJIFILM Medical Systems U.S.A., Inc. |
| K163058 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | BOSTON SCIENTIFIC |
| K162447 | PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) With EPK-i5010 Video Processor And HI VISION Preirus Ultrasound Scanner | PENTAX Of America, Inc. |
| K160845 | Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | BOSTON SCIENTIFIC CORPORATION |
| K133312 | EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE | Boston Scientific Corporation |
| 10816765014322 | Endoscopic ultrasound system, gastroenterology-urology |
| 04961333233793 | Endoscopic Ultrasound System, Gastroenterology-Urology |
| 04961333232567 | Endoscopic Ultrasound System, Gastroenterology-Urology |
| 04961333232550 | Endoscopic Ultrasound System, Gastroenterology-Urology |
| 04961333228409 | Endoscopic ultrasound system, gastroenterology-urology |
| 04961333228362 | Endoscopic ultrasound system, gastroenterology-urology |
| 04961333224463 | Endoscopic ultrasound system, gastroenterology-urology |
| 04961333171507 | Endoscopic ultrasound system, gastroenterology-urology |
| 04961333169054 | Endoscopic ultrasound system, gastroenterology-urology |
| 04961333148288 | Endoscopic ultrasound system, gastroenterology-urology |
| 04961333123339 | Endoscopic ultrasound system, gastroenterology-urology |
| 04961333123322 | Endoscopic ultrasound system, gastroenterology-urology |
| 04961333123315 | Endoscopic ultrasound system, gastroenterology-urology |
| 04961333113545 | Endoscopic ultrasound system, gastroenterology-urology |
| 04961333085002 | Endoscopic ultrasound system, gastroenterology-urology |
| ACQUIRE | BOSTON SCIENTIFIC CORPORATION | 2020-03-31 |
| EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-03-30 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-03-25 |
| ULTRASONIC GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-03-22 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-03-19 |
| ULTRASONIC GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-03-18 |
| ULTRASONIC GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-03-17 |
| ULTRASONIC GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-03-09 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-03-09 |
| ULTRASONIC GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-03-09 |
| EXPECT SLIMLINE SL | BOSTON SCIENTIFIC CORPORATION | 2020-03-06 |
| PENTAX | HOYA CORPORATION PENTAX TOKYO OFFICE | 2020-03-04 |
| ACQUIRE | BOSTON SCIENTIFIC CORPORATION | 2020-03-04 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-03-04 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-03-03 |
| PENTAX | HOYA CORPORATION PENTAX TOKYO OFFICE | 2020-03-03 |
| PENTAX | HOYA CORPORATION PENTAX TOKYO OFFICE | 2020-03-03 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-03-03 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-27 |
| ULTRASONIC GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-27 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-27 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-27 |
| ULTRASONIC GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-26 |
| ULTRASONIC GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-25 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-20 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-19 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-17 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-17 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-16 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-13 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-13 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-11 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-02-10 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-01-24 |
| ULTRASONIC GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-01-17 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-01-07 |
| EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-01-06 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-12-25 |
| ULTRASONIC GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-12-24 |
| ACQUIRE | BOSTON SCIENTIFIC CORPORATION | 2019-12-02 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-11-27 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-11-25 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-11-25 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-11-18 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-11-14 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-11-11 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-11-08 |
| ULTRASONIC GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-11-08 |
| EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-10-31 |
| ULTRASONIC GASTROVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2019-10-15 |