CUPTIMIZE™ Advanced
510(k) K231503
CUPTIMIZE™ Advanced is a Class II device made by Depuy Orthopaedics, Inc., cleared under FDA 510(k) K231503 on 22 Aug 2023, active as of 26 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231503 | Date22 Aug 2023 | StatusActive |
Official records
- FDA 510(k) database K231503
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K231503
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| CUPTIMIZE Advanced 4515-80-070 | 451580070 / 4515-80-070 | 10603295552093 | — | On the market |
| CUPTIMIZE Advanced 4515-80-071 | 451580071 / 4515-80-071 | 10603295552109 | — | On the market |
Similar devices
Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
- EzOrtho by Ewoosoft Co., Ltd.
- Synapse Cardiovascular by Fujifilm Medical System U.S.A., Inc.
- VM PACS WITH VM MEDICAL WORKSTATION by Visual Medica
- syngo Ultrasound Apps Suite (sUSAS) by SIEMENS MEDICAL SOLUTIONS USA, INC.
- Mimics Medical by Materialise NV
- IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 by Tomtec Imaging Systems GmbH
- PMD VIEWER by Spencer Technologies
- MD211G3 21.3 DIAGNOSTIC IMAGING LCD MONITOR by Prodigy Technology Consultant Co., Ltd.
- PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE by Philips Medical Systems North America, Inc.
- Vitrea Advanced Visualization, Version 7.6 by Vital Images, Inc.