PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "progeny" in a serif font. To the left of the word is a black graphic that appears to be two diamond shapes stacked on top of each other. The graphic is slightly tilted to the left. The word "progeny" is in lowercase letters. Image /page/0/Picture/2 description: The image shows a close-up of handwritten text, with the characters "K04182" prominently displayed at the top. Below this, there appears to be additional cursive writing, though it is somewhat blurred and less distinct. The overall impression is that of a document or label with a combination of alphanumeric identification and handwritten notes. # 510 (k) Summary AUG - 9 2004 As required by CFR section 807.92(c) #### General Information I. - July 2, 2004 Date: - Progeny Inc. Applicant: 1407 Barclay Blvd. Buffalo Grove, IL 60089 - E. M. Dolan Contact Person: - 847.850.3800, ext. 240 Telephone: - 847.459.5175 Fax: #### II. Names: Device Name: | Trade Name: | MPSe | |----------------------|-----------------------| | Common Name: | Progeny MPSe | | Classification Name: | Unit, X-ray Intraoral | #### III. Predicate Devices Schick Technologies Inc. CDR VisioDent RSV Durr Dental Vista Ray Trophy RVG #### IV. Product Description The X-ray MPS system is an intraoral receiver of the X-ray energy used by the dentist r ne A Tay NT & Systemler as vity. The MPSe sensor consists of 3 pieces: an X-ray to image toom an X-ray sensor driver and a power supply. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "progeny" in a serif font. To the left of the word is a black, stylized graphic that resembles a folded piece of paper or a stylized letter. The word "progeny" is written in lowercase letters. ing The Progeny MPSe Intraoral X-ray System consists of the following main components: Sensor X-Ray sensor driver Power Supply ## Accessories and Part Numbers X-ray sensor: By the number of the pixel array the CCD X-ray sensors that can be used with the MPSe driver are two. Number 1 has a matrix of 912 x 1368 (1.25 million pixels) and number 2 has 1250 x 1640 (2.05 million pixels). X-ray sensor driver: The driver module is a stand-alone or wall mounting It ray sellow a to a network storage device or display at a local display if the option is available. Power Supply: This is a medical certified unit that has 110-240V AC input and 12V output. Power Supplies that are also acceptable include medical certified power supply units with the output range of 6V to 26V . ### Other Devices The intraoral X-ray Sensor is intended for use in a Local Area Network in communication with storage devices such as Personal Computers or Laptops that are connected to the local network. #### Indications for Use / Rationale for Substantial Equivalence V. The MPSe System is to be used as an intraoral receiver of X-rays in Dental radiography. The MPSe shares the same indication for use, materials, design, operational and functional features and is therefore substantially equivalent to the predicate devices listed in section III of this summary. There are several major independent manufacturers of Intraoral Diagnostic Radiographic Systems on the US market. One is the Trophy Radiologie RVG. The 510(k) number is K950533. The classification of the Trophy Radiologie device is listed as product code EAP. The other currently marketed device is the Schick Technologies CDR. The 510(k) number is K933455. The classification of the Schick Technologies CDR is listed as product code EAP. Labeling for the currently marketed devices is included in section 2 of this document. {2}------------------------------------------------ | Image: Progeny Logo | Progeny, Inc. MPSe 510(k) | 7.2.04 | |---------------------|---------------------------|--------| | | | | There are several major independent manufacturers of Digital Intra Oral X-ray systems. I here are several major maopendo listed the most popular products from Schick In the comparison table below are not and Trophy in comparison to the Progeny MPSe digital X-ray system. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a handwritten text that appears to be a signature or a short note. The writing is somewhat illegible due to the style and quality of the image. The text seems to contain a combination of letters and possibly numbers, with some characters more distinct than others. Image /page/3/Picture/1 description: The image shows the word "progeny" in a serif font. The word is in lowercase letters. To the left of the word is a black graphic that looks like a stylized letter. # Comparison Table: | Characteristic | Schick<br>Technologies<br>Inc. | VisioDent | Durr<br>Dental | Trophy | Progeny Inc. | |------------------------------------|--------------------------------|--------------------|--------------------|--------------------|--------------------| | Product Name | CDR | RSV | Vista Ray | RVG | MPSe | | Number<br>sensors | 3 | 2 | 2 | 2 | 2 | | Sensor size<br>[mm] | 31 x 22<br>37 x 24<br>43 x 30 | 39 x 25<br>42 x 32 | 25 x 36<br>32 x 42 | 41 x 25<br>45 x 32 | 35 x 26<br>41 x 31 | | Technology | CMOS | CCD | CCD | CCD | CCD | | Interface to<br>PC | USB | USB | EPP | USB | Ethernet,<br>WLAN | | Dynamic<br>Range | 4096:1 | 4096 | 4096:1 | 4096:1 | 65536:1 | | Distance<br>between<br>Device & PC | | 5 | 5 or 30 | | Unlimited* | | Sensor Cable<br>length [m] | 2 | 2 | 2.5 | 2 | 2 | * Regarding IEEE802.3 Standard #### Safety and Effectiveness Information VI. In these safety instructions the word "system" refers to the Progeny MPSe and its accessories. 1. Read Instructions First: Please read and follow the safety and operating instructions before operating the system. 2. Retain Instructions: Keep the safety and operating instructions in a safe place for future reference. 3. Obey All Warnings: Warnings and cautions on the system and in safety and operating instructions must be adhered to. {4}------------------------------------------------ 1821 4. Following Instructions: If you have difficulty following or understanding the instructions in this booklet, call your dealer or supplier. orogeny 5. Cleaning: Unplug the system Power Cord from the wall outlet before cleaning. Do not spray any aerosol or non-aerosol sprays into the control unit or power supply. If not sprey any acreeee as as as and water on a damp cloth. Sterilization or disinfecting should be done only as recommended in the Section "Cleaning and Sterilization." 6. Moving: Do not place on an unstable surface. A system and cart combination o! Moring: Do noved with care. Quick stops, excessive force, and uneven surfaces may should be me rea will cart combination to overturn. Locate your system on a secure platform and avoid jarring the system while in operation. platform and a relea Jarring with an external DC power supply, and a three-wire grounding type plug (a plug having a third pin for grounding). The 3pronged plug must be operated only from standard 3-prong grounded wall outlets. If promoted plag man of the type of power supply to your office, consult your local power company. Company. The Power Supply will accept AC inputs in the range of 100-240 Volts, 50 or 60 Hz. In order to connect to the electrical power in a specific area, a detachable cord set with its' power plug approved for the particular AC receptacle must be used. This must be a Class I, 3-Wire, grounded connection. 8. Power Cord and Handpiece Cable Protection: The power cord and handpiece o. I o read on a car a d a that they are not likely to be walked on, pinched or kinked by items placed upon or against them. This may damage the cords and prevent the system from working properly. Pay particular attention to plugs and the point from which the cords exit the system. 9. Lightning: For added protection of this system during a lightning storm or when it is left unattended and unused for long periods of time, disconnect it from the wall outlet. This will prevent damage to the system due to lightning and power line surges. 10. Servicing: Except for the replacement of light bulbs, do not attempt to service this system yourself. Opening or removing covers may expose you to dangerous voltage or other hazards and may damage the system and void the warranty. 11. Ventilation: Openings in the system cabinet are provided to ensure proper ventilation. These openings must remain unobstructed at all times. Use caution when stacking the system near other equipment to ensure the normal operating temperature is not exceeded. Do not install this product into a closed rack or cabinet. Never place objects in or near openings in the cabinet. ### CAUTION: Never place the system on a soft surface that might block the ventilation openings in the bottom of the control unit. 12. Fluids: Keep fluids away from the system to avoid damage resulting from inadvertent spills. 13. Storage: Store the unit in temperatures of 10-40° C (50-104° F), humidity 0-90%. {5}------------------------------------------------ 7.2.04 14. Flammable Anesthetics: This equipment is not suitable for use with flammable anesthetics. anesments. 15. Mode of Operation: The mode of operation is continuous intermittent. 15. Mode of Operation: The mode of of protection is ordinary for this equipment. 16. Degree of Protection: The degree of protection is ordinary for this equipment. 10. Degree of I rotection: The dogres on inned protection from electric shock from 17. Auxmary Lquipment. 10 minute only to medical grade auxiliary equipment. icakage currents, it is important to e a statement: "Any TV, VCR, Printer, etc. must comply with the requirements on EN60601." 18. Damage Requiring Service: Disconnect the system from the wall outlet and 16. Damage Roquiering of Inc. under any of the following conditions: (a) If the power cord or handpiece cable is damaged. ogeny (b) If liquid has been spilled onto, or objects have fallen into the system. (0) If the system does not operate normally even if you follow the operating (C) it the system does not those controls that are covered by the operating instructions. Instructions: Adjustment or operation may result in damage and may require extensive work to restore the system to its normal operation. (d) If the product has been dropped or the cabinet has been damaged. (e) If the system exhibits a distinct change in performance. ## CAUTION: CAUTION. Do not attempt to remove the covers or service this product yourself. Dangerous Do not attempt to romovie the ode. Only the internal battery can be serviced in the voltages and hazards oney Replacement section for battery replacement. There are no other field serviceable parts inside your system. Refer all servicing to Progeny Inc. #### Conclusion VII. The Progeny MPSe System is determined to be substantially equivalent to the predicate 110 Trogery Mr 80 Byeathick Technologies CDR, The VisioDent RSV, The Durr Dental Vista Ray, and the Trophy RVG. The MPSe System is safe and effective when the device is used as labeled. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three thick, curved lines, giving it a modern and abstract appearance. Food and Drug Administra 9200 Corporate Boulevard Rockville MD 20850 AUG - 9 2004 Mr. E. M. Dolan Director of Quality Progeny, Inc. 1407 Barclay Blvd. BUFFALO GROVE IL 60089 Re: K041831 Trade/Device Name: Progeny MPSe Intraoral Dental X-ray Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: July 2, 2004 Received: July 19, 2004 Dear Mr. Dolan: We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Scenon 310(t) promation is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstated for use stated in the encrosure, to tegally mance to the Medical Device Amendments, or to commerce proct to May 20, 1770, the claciness with the provisions of the Federal Food, DNA devices that have been recuassince in accordance wall of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approval o You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, therefore, thatket the detect, cauge requirements for annual registration, listing of general controls provisions of the rest labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifical controls. Existing major regulations affecting your device can may be subject to such additional controls. Existing major regulations FDA may may be subject to such additional controls. Lincolney of the 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I same concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a determination that your active concessfiel. You must comply of the must comply or any Federal statures and regalations administration and listing (2) CFR Pat (2) CFR Pact with an the Act 3 requirements, meading, surfacturing practice requirements as set forth in the 807), labelling (21 CFR Part 820), BOOR Part 820); and if applicable, the electronic product quality Systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050. {7}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to ocgn marketing your any calence of your device to a legally premarket notification. The FDA imallig of substantial equivalities and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our lasting of the regulation number at the top of the letter: | 8xx. Ixxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and come of the regulation entitled, "Masbranding Office of Compliance at (301) 594-4639. Also, please note their - Other opense Othce of Compliance at (301) 394-4037. This, production of Some the Dinains of Sma by reference to premarket nomication (210) it it it is a brained from the Division of Small information on your responsibilities under the Act may be obtained from worker (80 information on your responsionities under the Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance in and includers (1800 Manufacturers, International and Collisation - Posicialist - Posicitires - Posts - Posts - Sollardsmamain.html. Sincerely yours, Nancy C. Boyden Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ page of 510(k) Number (if known): K041831 Device Name: Progeny MPse Intra-oral Dental X-ray Senso Indications For Use: Statement of Indication for Use: Intended Use: The Progety MPSe system is intended to use for acquisition of digital images of intra-The Progeny MPSe system is intended to use for acquisition of expection of growth interest to a computer for display by Ethernet. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Pct 21 CFR 801.109) OR Over-The-Counter Use (Optional Formal 1-2-96) Nancu C. Broadion (Division Sign-Off) Division of Reproductive. Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________