Pinnacle Radiation Therapy Planning System
2 catalogue numbers from 16.4, listed by Philips Medical Systems (Cleveland), Inc., United States, under System, Planning, Radiation Therapy Treatment. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Fujian (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Manteia Technologies Co., Ltd. | Xiamen | Fujian | Manufacturer | 3 |
| Masep Medical Science & Technology DEVELOPMENT(SHENZHEN)Co. | Shenzhen | Guangdong | Manufacturer | 2 |
| Suzhou Linatech Medical Science AND Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Varian Medical Systems China Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Philips Medical Systems (Cleveland), Inc., United States |
|---|---|
| FDA product code | MUJ |
| Device type | System, Planning, Radiation Therapy Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K170086 |
| Record published | 2020-11-10 |
| Record revised | 2022-02-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2030-11-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16.4 | In distribution | |
| 18.0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RayStation | RaySearch Laboratories AB (publ) | 29 |
| System, Planning, Radiation Therapy Treatment | Nucletron B.V. | 17 |
| Panther TPS | Prowess, Inc. | 14 |
| RayCare | RaySearch Laboratories AB (publ) | 12 |
| Accuray Precision® Treatment Planning System | Accuray Incorporated | 7 |
| Monaco | Elekta Inc. | 7 |
| Eclipse Treatment Planning System for External Beam Radiation Therapy | Varian Medical Systems, Inc | 6 |
| syngo.via RT Image Suite | Siemens Healthcare Limited | 5 |
| Eclipse Treatment Planning System | Varian Medical Systems, Inc | 5 |
| Corvus 09 | Best Nomos | 4 |
| Monaco | Elekta Solutions AB | 4 |
| XKnife® | Integra Lifesciences Corporation | 4 |
Showing 12 of 98. All products under System, Planning, Radiation Therapy Treatment
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170086 | 2017-02-09 |
| K974770 | 1998-09-02 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips Medical Systems (Cleveland), Inc. | 510(k) number | 2025-08-05 | Class II | Software design | Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations. | 810 (350 U.S. and 460 O.U.S.) |
| Philips Medical Systems (Cleveland), Inc. | 510(k) number | 2025-07-17 | Class II | Software change control | Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the “Stopping Power Ratio” (SPR) , | 149 Serial Numbers |
| Philips Medical Systems (Cleveland), Inc. | 510(k) number | 2022-08-30 | Class II | Device Design | When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen. | 169 systems |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-02-11 | Class II | Software design | Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from 09/29/09 to 12/0 | 1016 | 2014-11-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.