CEMAX-1000
FDA 510(k) K833525 · Contour Medical Systems, Inc.
510(k) numberK833525
Submission
- Device name
- CEMAX-1000
- Applicant
- Contour Medical Systems, Inc.
Mchenry, IL, US - Received
- September 22, 1983
- Decision date
- November 21, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code LMB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992131 | Samsung Raypax Long Term ArchiveLMB · Traditional | Samsung Sds Co., Ltd. | 09/13/1999SE |
| K984405 | Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000LMB · Traditional | Intracom Corp. | 02/08/1999SE |
| K983447 | Wise (II) Image Management SystemLMB · Special | Sectra-Imtec AB | 10/29/1998SE |
| K980243 | Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis)LMB · Traditional | Parameter Developments, Inc. | 04/03/1998SE |
| K973463 | Olicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE, ArchiveLMB · Traditional | O Tech, Inc. | 12/02/1997SE |
| K973413 | Id. Store (Release 2.0)LMB · Traditional | I.S.G. Technologies, Inc. | 11/25/1997SE |
| K972380 | Kodak Digital Science (KDS) Medical Image and Information Library (Miil)LMB · Traditional | Eastman Kodak Company | 09/11/1997SE |
| K971848 | TDK Medical Grade Cd-RLMB · Traditional | Tdk Electronics Corporation of America | 08/15/1997SE |
| K971451 | Wise Image Management SystemLMB · Traditional | O Tech, Inc. | 06/26/1997SE |
| K963936 | Accesspoint, Med E-Mail, Dicom ReaderLMB · Traditional | Biosound, Inc. | 03/31/1997SE |
Questions and answers
When was CEMAX-1000 cleared by the FDA?
CEMAX-1000 (K833525) received a 510(k) decision of Substantially Equivalent on November 21, 1983, 60 days after the submission was received.
What is the product code of K833525?
The FDA product code is LMB – Device, Digital Image Storage, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2010.