Regulation Number |
Device Name |
Device Class |
Product Code |
§864.1860 |
Automated Digital Image Manual Interpretation Microscope
|
Class 2
|
OEO
|
§864.3700 |
Whole Slide Imaging System
|
Class 2
|
PSY
|
§864.3700 |
Digital Pathology Display
|
Class 2
|
PZZ
|
§864.3700 |
Digital Pathology Image Viewing And Management Software
|
Class 2
|
QKQ
|
§874.4680 |
Bronchoscope (Flexible Or Rigid)
|
Class 2
|
EOQ
|
§874.4710 |
Esophagoscope (Flexible Or Rigid)
|
Class 2
|
EOX
|
§874.4760 |
Nasopharyngoscope (Flexible Or Rigid)
|
Class 2
|
EOB
|
§876.1300 |
System, Imaging, Gastrointestinal, Wireless, Capsule
|
Class 2
|
NEZ
|
§876.1300 |
System, Imaging, Esophageal, Wireless, Capsule
|
Class 2
|
NSI
|
§876.1310 |
Magnetically Maneuvered Capsule Endoscopy System
|
Class 2
|
QKZ
|
§876.1330 |
Colon Capsule Imaging System
|
Class 2
|
PGD
|
§876.1500 |
Cystoscope And Accessories, Flexible/Rigid
|
Class 2
|
FAJ
|
§876.1500 |
Sigmoidoscope And Accessories, Flexible/Rigid
|
Class 2
|
FAM
|
§876.1500 |
Sigmoidoscope, Rigid, Electrical
|
Class 2
|
FAN
|
§876.1500 |
Choledochoscope And Accessories, Flexible/Rigid
|
Class 2
|
FBN
|
§876.1500 |
Cystourethroscope
|
Class 2
|
FBO
|
§876.1500 |
Telescope, Rigid, Endoscopic
|
Class 2
|
FBP
|
§876.1500 |
Enteroscope And Accessories
|
Class 2
|
FDA
|
§876.1500 |
Colonoscope And Accessories, Flexible/Rigid
|
Class 2
|
FDF
|
§876.1500 |
Duodenoscope And Accessories, Flexible/Rigid
|
Class 2
|
FDT
|
§876.1500 |
Anoscope And Accessories
|
Class 2
|
FER
|
§876.1500 |
Kit, Nephroscope
|
Class 2
|
FGA
|
§876.1500 |
Ureteroscope And Accessories, Flexible/Rigid
|
Class 2
|
FGB
|
§876.1500 |
Urethroscope
|
Class 2
|
FGC
|
§876.1500 |
Resectoscope
|
Class 2
|
FJL
|
§876.1500 |
Laparoscope, General & Plastic Surgery
|
Class 2
|
GCJ
|
§876.1500 |
Endoscope, Rigid
|
Class 2
|
GCM
|
§876.1500 |
Endoscope, Flexible
|
Class 2
|
GCQ
|
§876.1500 |
Angioscope
|
Class 2
|
LYK
|
§876.1500 |
Endoscope, Accessories, Narrow Band Spectrum
|
Class 2
|
NWB
|
§876.1500 |
Endoscopic Cholangiogram Kit
|
Class 2
|
NWT
|
§876.1500 |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
Class 2
|
OCS
|
§876.1500 |
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
|
Class 2
|
ODE
|
§876.1500 |
Endoscope, Accessories, Image Post-Processing For Color Enhancement
|
Class 2
|
PEA
|
§876.1520 |
Gastrointesinal Lesion Software Detection System
|
Class 2
|
QNP
|
§884.1600 |
Amnioscope, Transabdominal (Fetoscope) (And Accessories)
|
HDE
|
HFA
|
§884.1630 |
Colposcope (And Colpomicroscope)
|
Class 2
|
HEX
|
§884.1630 |
Vaginoscope And Accessories
|
Class 2
|
MOK
|
§884.1640 |
Culdoscope (And Accessories)
|
Class 2
|
HEW
|
§884.1690 |
Hysteroscope (And Accessories)
|
Class 2
|
HIH
|
§884.1690 |
Falloposcope
|
Class 2
|
MKO
|
§884.1720 |
Laparoscope, Gynecologic (And Accessories)
|
Class 2
|
HET
|