The following data is part of a premarket notification filed by Radiology Information Systems, Inc. with the FDA for Acculmaing.
| Device ID | K102849 |
| 510k Number | K102849 |
| Device Name: | ACCULMAING |
| Classification | System, Image Processing, Radiological |
| Applicant | RADIOLOGY INFORMATION SYSTEMS, INC. 1468 HARWELL AVE. Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith RADIOLOGY INFORMATION SYSTEMS, INC. 1468 HARWELL AVE. Crofton, MD 21114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-29 |
| Decision Date | 2010-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860009490628 | K102849 | 000 |